# ketryx.com > AI-optimized mirror of ketryx.com containing 757 pages totalling 267,352 words of clean markdown content, structured data, and semantic HTML. Original source: https://ketryx.com/. Last updated: 2026-07-03T14:59:21.563Z. Each page is available as HTML (with JSON-LD structured data) and Markdown (text-only, ideal for LLMs and RAG). ## Homepage - [Ketryx Trust Center | Powered by SafeBase](/content/trust/index.html): SafeBase monitors your security practices to enable you to win enterprise deals. (442 words) - [FDA, EU MDR, & ISO Compliance Software & Application Lifecycle Management (ALM) - Ketryx](/content/site-root.html): Build with FDA compliance and ALM software 3x faster with Ketryx Compliance Framework. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (696 words) ## Articles & Blog Posts - [Data Processing Addendum - Ketryx](/content/legal/data-processing-addendum/index.html): Build with FDA compliance and ALM software 3x faster with Ketryx Compliance Framework. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (3,185 words) - [Service Level Agreement - Ketryx](/content/legal/service-level-agreement/index.html): Build with FDA compliance and ALM software 3x faster with Ketryx Compliance Framework. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (893 words) - [Terms of Service - Ketryx](/content/legal/terms-of-service/index.html): ‍These Terms form a binding contract between Customer and Ketryx when accepted by Customer (“acceptance”). Customer accepts these Terms by (1) signing an Order referencing these Terms; (2) clicking... (5,848 words) - [What payload size and timeout limits should we configure on the proxy for Ketryx<->JDC integration flows? – Ketryx](/content/support/hc/en-us/articles/46954247472269-what-payload-size-and-timeout-limits-should-we-configure-on-the-proxy-for-ketryx-jdc-integration-flows.html): The nginx default request body limit of 1 MB is too small for some integration payloads, and the default 60s send/read timeouts can cut... (129 words) - [Azure DevOps - Ketryx Integrations](/content/integrations/azure-devops/index.html) (256 words) - [Page Not Found - Ketryx Compliance Framework](/content/ai-agents/index.html) (9 words) - [Webinars - How to Make Compliance Continuous for AI-Enabled SaMD - Ketryx Compliance Framework](/content/learn/webinars/register/how-to-make-compliance-continuous-for-ai-enabled-samd.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (182 words) - [Data Processing Addendum - June 2025 - Ketryx](/content/legal/data-processing-addendum-june-2025/index.html): This Data Processing Addendum (“Addendum”) supplements the Master Services Agreement (the “Agreement”) entered into by and between Customer (“Customer”) and Ketryx Corporation (“Ketryx”). This Adde... (3,189 words) - [EU CRA](/content/capabilities/eu-cra/index.html): A top 5 MedTech Surgical Robotics company partnered with Ketryx to modernize its cybersecurity risk assessment process and accelerate vulnerability assessments. After improving their Cybersecurity ... (993 words) - [robots-txt.html](/content/robots-txt.html) (8 words) - [Service Level Agreement - July 2025 - Ketryx](/content/legal/service-level-agreement-july-2025/index.html): Build with FDA compliance and ALM software 3x faster with Ketryx Compliance Framework. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (284 words) - [Former Medtronic CEO Bill Hawkins Joins Ketryx Board to Solve the AI Bottleneck in Life Sciences - Ketryx Compliance Framework](/content/press-release/bill-hawkins-joins-ketryx-board/index.html): Medical device leader joins Ketryx as regulated industries search for solutions to implement safe, verifiable AI at scale. (654 words) - [Former Medtronic CEO Joins Ketryx Board](/content/blog/former-medtronic-ceo-joins-ketryx-board/index.html): The appointment occurs as regulated industries search for solutions to implement safe, verifiable AI at scale. (173 words) - [Ex-Medtronic CEO Bill Hawkins joins Ketryx board](/content/blog/ex-medtronic-ceo-bill-hawkins-joins-ketryx-board/index.html): Retired Medtronic Chair and CEO Bill Hawkins has joined the Ketryx board, the medtech regulatory software developer will announce today. (197 words) - [How do you configure authentication via Okta? – Ketryx](/content/support/hc/en-us/articles/21758815519501-how-do-you-configure-authentication-via-okta.html): For authentication via Okta, create a new App Integration in your Okta instance and configure it in the following way: ... (234 words) - [How can an organization define custom authentication methods based on company domain? – Ketryx](/content/support/hc/en-us/articles/21758382028813-how-can-an-organization-define-custom-authentication-methods-based-on-company-domain.html): Once Ketryx Support verifies and configures a specific email domain for your organization, users trying to log in with an email address... (242 words) - [Why does the Ketryx login say "User... not found. Please sign up first" when trying to log in? – Ketryx](/content/support/hc/en-us/articles/21759031602573-why-does-the-ketryx-login-say-user-not-found-please-sign-up-first-when-trying-to-log-in.html): Ketryx requires some data for each new user, including your full name and organization. When trying to log in with an email address that... (87 words) - [Which authentication methods does Ketryx support? What SSO methods are available? – Ketryx](/content/support/hc/en-us/articles/21757990675085-which-authentication-methods-does-ketryx-support-what-sso-methods-are-available.html): By default, Ketryx supports the following authentication methods: Login via email (by clicking a "magic... (76 words) - [I submitted a spdx file via the Build API. Why aren't any or all dependencies loading in Ketryx? – Ketryx](/content/support/hc/en-us/articles/33377788131981-i-submitted-a-spdx-file-via-the-build-api-why-aren-t-any-or-all-dependencies-loading-in-ketryx.html): Ketryx can scan SPDX files, reported to Ketryx via the Build API, to extract crucial information about software packages, including... (280 words) - [What is the difference between the release vulnerability report and the "on-demand" vulnerability report data grid option on the Vulnerabilities page? – Ketryx](/content/support/hc/en-us/articles/30905424844685-what-is-the-difference-between-the-release-vulnerability-report-and-the-on-demand-vulnerability-report-data-grid-option-on-the-vulnerabilities-page.html): The vulnerability report can be downloaded in three different ways. The first way is through the release documents page. The second is... (272 words) - [Can Ketryx scan for dependencies outside of the built-in dependency scanner languages? – Ketryx](/content/support/hc/en-us/articles/31182931140109-can-ketryx-scan-for-dependencies-outside-of-the-built-in-dependency-scanner-languages.html): Yes! Outside of the built-in dependency scanner languages, Ketryx is able to support C#, C++, R and other languages not accounted for in... (172 words) - [Can I invite other users from outside the company domain (e.g., auditors)? – Ketryx](/content/support/hc/en-us/articles/21759063716109-can-i-invite-other-users-from-outside-the-company-domain-e-g-auditors.html): Yes, as an organization member with the Invite members permission, you can invite any other member based on their email address, even if... (79 words) - [How does Ketryx manage vulnerabilities as opposed to product and patient related risks? – Ketryx](/content/support/hc/en-us/articles/26344769795853-how-does-ketryx-manage-vulnerabilities-as-opposed-to-product-and-patient-related-risks.html): Ketryx automatically detects vulnerabilities in your repositories and presents them on the Vulnerabilities page within the SBOM module.... (115 words) - [How can I use "Release ref pattern" for connected repositories in the Ketryx project settings? – Ketryx](/content/support/hc/en-us/articles/30926144259725-how-can-i-use-release-ref-pattern-for-connected-repositories-in-the-ketryx-project-settings.html): Versioning items can be important when using Ketryx. Point-wise items will only appear in the version they are marked with, and... (192 words) - [How do I enable transitive dependencies for my SBOM? – Ketryx](/content/support/hc/en-us/articles/26048022136205-how-do-i-enable-transitive-dependencies-for-my-sbom.html): Ketryx built-in dependency scanning currently only supports direct dependencies of a project, e.g. top-level dependencies. To enable... (79 words) - [What languages does Ketryx built-in dependency scanning support? – Ketryx](/content/support/hc/en-us/articles/31174363679629-what-languages-does-ketryx-built-in-dependency-scanning-support.html): See latest list of supported languages in Ketryx documentation. (20 words) - [How do I have each component of my medical device upload an SBOM independently? When using the GitHub action to upload an SBOM, why does a specific version override the content of what I had previously uploaded? – Ketryx](/content/support/hc/en-us/articles/27487327158925-how-do-i-have-each-component-of-my-medical-device-upload-an-sbom-independently-when-using-the-github-action-to-upload-an-sbom-why-does-a-specific-version-override-the-content-of-what-i-had-previously-uploaded.html): Distinguish between different, effective builds. If you would like to utilize multiple, parallel, effective builds at the same time, you... (117 words) - [How can I use "Analyzed branch or tag" for connected repositories in the Ketryx project settings? – Ketryx](/content/support/hc/en-us/articles/30924834051469-how-can-i-use-analyzed-branch-or-tag-for-connected-repositories-in-the-ketryx-project-settings.html): The Analyzed branch or tag setting allows you to restrict the path(s) within your repository that should be "read" by Ketryx.... (149 words) - [Can I use Ketryx for C# dependencies management if I have Snyk or FOSSA? – Ketryx](/content/support/hc/en-us/articles/28128298892941-can-i-use-ketryx-for-c-dependencies-management-if-i-have-snyk-or-fossa.html): Yes. Since both Snyk and FOSSA can scan for C# dependencies, you can use Ketryx for dependencies and SBOM management. Yes, Ketryx scans... (103 words) - [Can I restrict which files from my repository are considered when Ketryx scans for dependencies? – Ketryx](/content/support/hc/en-us/articles/30922093460621-can-i-restrict-which-files-from-my-repository-are-considered-when-ketryx-scans-for-dependencies.html): Absolutely! For each repository connected to a project, you can optionally select "Restrict dependency file locations". When... (92 words) - [Does Ketryx Support Code Change Reviews (CCR) using GitLab? – Ketryx](/content/support/hc/en-us/articles/21757126498317-does-ketryx-support-code-change-reviews-ccr-using-gitlab.html): Ketryx does not support Code Change Reviews with GitLab at this time. We are working on adding this feature in the future. Please reach... (46 words) - [If we utilize different scanners, does Ketryx take this into account so we know what we have mitigated and what we haven't? – Ketryx](/content/support/hc/en-us/articles/27484255703565-if-we-utilize-different-scanners-does-ketryx-take-this-into-account-so-we-know-what-we-have-mitigated-and-what-we-haven-t.html): Yes, Ketryx is designed to integrate and analyze data from multiple vulnerability scanners. By comparing unique identifiers, such as... (82 words) - [How frequently does Ketryx scan the repository? – Ketryx](/content/support/hc/en-us/articles/31173740660621-how-frequently-does-ketryx-scan-the-repository.html): Ketryx scans upon initial setup, manual project sync via the SBOM module (click the “Refresh from Git” button), or if a file is reported... (50 words) - [Does Ketryx integrate with multiple vulnerability scanners beyond what is native in Ketryx? – Ketryx](/content/support/hc/en-us/articles/27484122855821-does-ketryx-integrate-with-multiple-vulnerability-scanners-beyond-what-is-native-in-ketryx.html): Yes, Ketryx scans SPDX files and your vulnerability scanner can likely output in this format. It parses the SPDX file and creates... (72 words) - [How is our connected source code repository processed by Ketryx? – Ketryx](/content/support/hc/en-us/articles/31173445927821-how-is-our-connected-source-code-repository-processed-by-ketryx.html): Repository data is downloaded to Ketryx infrastructure and scanned for processable files. The scan results are then processed. Once... (58 words) - [How do I utilize my biometric scanner for MFA if I am using 1Password? – Ketryx](/content/support/hc/en-us/articles/21798737138061-how-do-i-utilize-my-biometric-scanner-for-mfa-if-i-am-using-1password.html): When you get a prompt to use a security key to authenticate, click Use Security Key Next, click the button show in the 1Password prompt... (59 words) - [Why don't cybersecurity risk management fields copy over across all projects that share a repository in the SBoM module? Do I have to copy over information from the other project or is there an easy way to move this data? – Ketryx](/content/support/hc/en-us/articles/24712835634317-why-don-t-cybersecurity-risk-management-fields-copy-over-across-all-projects-that-share-a-repository-in-the-sbom-module-do-i-have-to-copy-over-information-from-the-other-project-or-is-there-an-easy-way-to-move-this-data.html): When performing Software Bill of Materials (SBoM) or cybersecurity risk management in one project, it might seem logical that the same... (271 words) - [Is there an audit log for system access? – Ketryx](/content/support/hc/en-us/articles/21759149171085-is-there-an-audit-log-for-system-access.html): Yes, all relevant actions of organization members are logged in an audit change log, which can be accessed by organization owners at the... (58 words) - [Can I change the version number pattern in an existing project? – Ketryx](/content/support/hc/en-us/articles/38906394897037-can-i-change-the-version-number-pattern-in-an-existing-project.html): It is strongly recommended to establish a consistent version numbering pattern at the beginning of a project and avoid changing it once... (227 words) - [Does Ketryx support Yarn v2+? – Ketryx](/content/support/hc/en-us/articles/21780470733325-does-ketryx-support-yarn-v2/index.html): Yes, Ketryx supports yarn version 1-4. (14 words) - [Can I export Risk items from Ketryx? – Ketryx](/content/support/hc/en-us/articles/33815149142925-can-i-export-risk-items-from-ketryx/index.html): Yes. Ketryx has an out-of-the-box (OOB) Risk Matrix that can be generated on-demand. To understand how to generate release documents,... (187 words) - [How can I create a custom field that is also editable in Ketryx? – Ketryx](/content/support/hc/en-us/articles/33980076701581-how-can-i-create-a-custom-field-that-is-also-editable-in-ketryx.html): Instructions on how to add custom fields to configuration items that are also editable in Ketryx can be found in our documentation here.... (188 words) - [Do open source SBOM generation tools introduce risk? – Ketryx](/content/support/hc/en-us/articles/33469434642445-do-open-source-sbom-generation-tools-introduce-risk.html): Introducing any software into your environment may introduce risk and therefore an appropriate supplier assessment should be conducted,... (70 words) - [How do I create a fine-grained Personal Access Token for GitHub? – Ketryx](/content/support/hc/en-us/articles/21757048657293-how-do-i-create-a-fine-grained-personal-access-token-for-github.html): Please see GitHub's documentation for more information on how to create a fine-grained PAT. NOTE: Make sure to choose... (143 words) - [For fields in Jira with field types "Paragraph" and “Number,” how do I add them into custom item fields configuration? – Ketryx](/content/support/hc/en-us/articles/38927573261197-for-fields-in-jira-with-field-types-paragraph-and-number-how-do-i-add-them-into-custom-item-fields-configuration.html): When adding custom item fields into Ketryx, the types of field options available in the custom item fields configuration in advanced... (116 words) - [Supply Chain Management: Software Dependencies – Ketryx](/content/support/hc/en-us/sections/23504268128013-supply-chain-management-software-dependencies.html): The purpose of this section is to answer questions related to the use of Ketryx Software Supply Chain Configuration Management to manage... (451 words) - [Can I omit the need for owner approval for certain items? – Ketryx](/content/support/hc/en-us/articles/33951656694285-can-i-omit-the-need-for-owner-approval-for-certain-items.html): Yes, the need for owner approval is configurable in the project advanced settings under "Approval rules". Normally in this... (137 words) - [Can I reverse a change in Jira and Ketryx? – Ketryx](/content/support/hc/en-us/articles/34411871899789-can-i-reverse-a-change-in-jira-and-ketryx.html): Yes, you can revert an item record to an earlier version. When you open an item in Ketryx from the All Items screen, you can see its item... (160 words) - [Who should be the owner of the Jira issue? – Ketryx](/content/support/hc/en-us/articles/21853814141325-who-should-be-the-owner-of-the-jira-issue.html): Normally, the owner of the Jira issue should be the person working on the issue. The owner of the issue could be changed (reassigned) if... (155 words) - [What Advanced Settings should I change when I "Use existing Jira configuration" for a new Ketryx Project – Ketryx](/content/support/hc/en-us/articles/34459704197261-what-advanced-settings-should-i-change-when-i-use-existing-jira-configuration-for-a-new-ketryx-project.html): When you create a new Jira-connected project in Ketryx, you have two options for Jira configurations: Use Ketryx Issue Types, Screens... (1,802 words) - [Does Ketryx offer integration with Git but not with GitHub for managing requirements, specifications, and test cases? Should these be written as markdown files instead of GitHub issues? – Ketryx](/content/support/hc/en-us/articles/23640520697613-does-ketryx-offer-integration-with-git-but-not-with-github-for-managing-requirements-specifications-and-test-cases-should-these-be-written-as-markdown-files-instead-of-github-issues.html): Ketryx provides a Git integration that supports the creation of configuration items as Markdown files. This feature is compatible with... (137 words) - [Why are my statuses in Jira not syncing to the correct states in Ketryx? – Ketryx](/content/support/hc/en-us/articles/38927784039821-why-are-my-statuses-in-jira-not-syncing-to-the-correct-states-in-ketryx.html): The first step to troubleshooting this problem is to ensure that the project in Ketryx has been synced with Jira. Note: After an initial... (241 words) - [How do I apply our configured Ketryx settings across all projects? – Ketryx](/content/support/hc/en-us/articles/21762823864077-how-do-i-apply-our-configured-ketryx-settings-across-all-projects.html): For a complete guide on "Advanced Settings", read our training documentation here. Advanced settings may be configured on the... (106 words) - [What fields can be retrieved through REST API call? – Ketryx](/content/support/hc/en-us/articles/38216521340557-what-fields-can-be-retrieved-through-rest-api-call.html): Currently, only default fields in Ketryx are accessible through the REST API when retrieving item details, which can be done through the... (95 words) - [Why are there fewer dependencies in the Ketryx SBOM module than parsed and shown on the build page? – Ketryx](/content/support/hc/en-us/articles/33469493841293-why-are-there-fewer-dependencies-in-the-ketryx-sbom-module-than-parsed-and-shown-on-the-build-page.html): One reason why there may be fewer dependencies in the SBOM module than on the build page, is that the uploaded SBOM contains transitive... (105 words) - [Advanced Settings – Ketryx](/content/support/hc/en-us/sections/26302138178957-advanced-settings/index.html) (472 words) - [Can I change the timezone on my templated documents? – Ketryx](/content/support/hc/en-us/articles/32427960165005-can-i-change-the-timezone-on-my-templated-documents.html): Yes! When you are printing something like:{createdAt}it will return a datetime object of default display format. Understanding the... (197 words) - [How do I create a Personal Access Token (PAT) (classic) for GitHub? – Ketryx](/content/support/hc/en-us/articles/21756997496717-how-do-i-create-a-personal-access-token-pat-classic-for-github.html): Please see GitHub's documentation or follow the following steps to create a PAT: Go to your GitHub account... (126 words) - [How do I create an App Password for Bitbucket? – Ketryx](/content/support/hc/en-us/articles/21752095570445-how-do-i-create-an-app-password-for-bitbucket.html): Please see Bitbucket's documentation for information on how to create an App Password. When entering the... (87 words) - [How can I add my own types of requirements in the Ketryx Requirement Type field? – Ketryx](/content/support/hc/en-us/articles/33980507891597-how-can-i-add-my-own-types-of-requirements-in-the-ketryx-requirement-type-field.html): The Ketryx field Requirement type has a strict list of 37 options for a type of requirement. To add custom names for requirement types,... (283 words) - [How do I create a Repository Access Token for Bitbucket? – Ketryx](/content/support/hc/en-us/articles/21752061838221-how-do-i-create-a-repository-access-token-for-bitbucket.html): A guide on how to create such a token can be found here. The same authentication method is used to fetch the Git... (83 words) - [How can I integreate with GitHub repositories? – Ketryx](/content/support/hc/en-us/articles/21756772560013/index.html): The integration process with GitHub varies slightly depending on whether you are working with public or private repositories. Here's a... (214 words) - [How do you validate the agents? Do you have to validate them as they keep learning or as the model is updated? – Ketryx](/content/support/hc/en-us/articles/37340758570637-how-do-you-validate-the-agents-do-you-have-to-validate-them-as-they-keep-learning-or-as-the-model-is-updated.html): We validate Ketryx Agents by designing test scenarios that simulate real-world use casesand cover both typical and edge-case... (162 words) - [What are the limitations of Jira users without Ketryx accounts? Do I need a Ketryx account? – Ketryx](/content/support/hc/en-us/articles/22251527181581-what-are-the-limitations-of-jira-users-without-ketryx-accounts-do-i-need-a-ketryx-account.html): Jira users without Ketryx accounts are not able to approve items. Additionally, they will not have access to the Ketryx platform to view... (121 words) - [What package managers does Ketryx support and and how does Ketryx utilize these package managers for its operations? – Ketryx](/content/support/hc/en-us/articles/23640426787213-what-package-managers-does-ketryx-support-and-and-how-does-ketryx-utilize-these-package-managers-for-its-operations.html): Ketryx utilizes package managers as a key part of its process for automatically detecting software bill of materials (SBOM) and... (70 words) - [How do I change the tag delimiter in a templated document? – Ketryx](/content/support/hc/en-us/articles/30636900050189-how-do-i-change-the-tag-delimiter-in-a-templated-document.html): Ketryx has a powerful document templating mechanism that can generate highly customizable documents for Milestones and Releases. Certain... (323 words) - [Traceability – Ketryx](/content/support/hc/en-us/sections/23504346139405-traceability/index.html): The purpose of this section is to answer questions related to the setup and processes for interpreting, maintaining and verifying the... (318 words) - [Ketryx Agents and Assistant – Ketryx](/content/support/hc/en-us/sections/37333057263501-ketryx-agents-and-assistant/index.html) (171 words) - [Can an item retain its approvals when transitioning from a controlled status (e.g., Closed/Approved) to 'Obsolete'? – Ketryx](/content/support/hc/en-us/articles/38205586792973-can-an-item-retain-its-approvals-when-transitioning-from-a-controlled-status-e-g-closed-approved-to-obsolete.html): To maintain approvals when transitioning from a controlled state such as "Approved" or "Closed" to an obsolete or... (181 words) - [Why are there differences between the vulnerabilities shown in the SBOM module and on the Vulnerability page? – Ketryx](/content/support/hc/en-us/articles/33469559674253-why-are-there-differences-between-the-vulnerabilities-shown-in-the-sbom-module-and-on-the-vulnerability-page.html): The primary reason that there may be differences between the vulnerabilities shown in the SBOM module and on the Vulnerability page is... (132 words) - [What is the difference between the "Open" and "In Progress" states? – Ketryx](/content/support/hc/en-us/articles/21854117688461-what-is-the-difference-between-the-open-and-in-progress-states.html): Open - The item is proposed. In Progress - The item proposal is being drafted into a final proposal. The ticket can be... (52 words) - [What are my options for electronic signatures in Ketryx? – Ketryx](/content/support/hc/en-us/articles/42366628823181-what-are-my-options-for-electronic-signatures-in-ketryx.html): Understanding Signature Types in KetryxKetryx supports two types of Part 11 compliant signatures: Click-through signatures: Users... (344 words) - [Do system-level controls apply to custom item types? – Ketryx](/content/support/hc/en-us/articles/39101855857805-do-system-level-controls-apply-to-custom-item-types.html): Yes, system-level controls in Ketryx do apply to custom item types as they behave in the same way as default item types, including being... (137 words) - [The page you were looking for doesn't exist – Ketryx](/content/support/hc/en-us/articles/30854773095053-can-i-configure-ketryx-to-require-multi-factor-authentication-mfa-only-for-certain-actions.html) (21 words) - [Does Ketryx Support Multiple Traceability Matrices? – Ketryx](/content/support/hc/en-us/articles/34649528754445-does-ketryx-support-multiple-traceability-matrices.html): Yes, Ketryx can support multiple traceability matrices. Organizations often maintain multiple discipline-specific traceability areas. ... (539 words) - [Where do Ketryx Agents source their data, and what access do they have to my data? – Ketryx](/content/support/hc/en-us/articles/37340739529741-where-do-ketryx-agents-source-their-data-and-what-access-do-they-have-to-my-data.html): Agents can consume data from any document or system connected to Ketryx. This might include your QMS and connected systems like Jira,... (45 words) - [Do Ketryx Agents train on our data? – Ketryx](/content/support/hc/en-us/articles/37333103725965-do-ketryx-agents-train-on-our-data/index.html): Ketryx-connected AI vendors, including OpenAI, are restricted through a zero-dataretention endpoint from storing and using the data... (71 words) - [How is my data secured when using Ketryx AI features? – Ketryx](/content/support/hc/en-us/articles/40700429234317-how-is-my-data-secured-when-using-ketryx-ai-features.html): Ketryx upholds enterprise-grade security standards, validated through SOC 2 Type II. The description below provides a technical overview... (273 words) - [What are the definitions and origins of the change types listed in our Work Instructions (Corrective, Preventive, Adaptive, Perfective), and can these be customized in Ketryx? – Ketryx](/content/support/hc/en-us/articles/38158862911757-what-are-the-definitions-and-origins-of-the-change-types-listed-in-our-work-instructions-corrective-preventive-adaptive-perfective-and-can-these-be-customized-in-ketryx.html): These four types of change come from ISO/IEC 14764: Corrective: modifications of software to fix a bug or other failure to meet... (177 words) - [How do I import data into my Jira project? – Ketryx](/content/support/hc/en-us/articles/36221222607117-how-do-i-import-data-into-my-jira-project.html): Jira has a powerful import tool that can be used for data migrations, even if they are from one project to another within the same... (2,170 words) - [What are "used dependencies"? – Ketryx](/content/support/hc/en-us/articles/21759819175565-what-are-used-dependencies/index.html): Used Dependencies are for managing Software of Unknown Provenance (SOUP) in the Ketryx Dependencies Module. IEC 62304 Section 8.1.2... (128 words) - [How can I filter and manage risks of different types? – Ketryx](/content/support/hc/en-us/articles/35013768180109-how-can-i-filter-and-manage-risks-of-different-types.html): Risks can be viewed in Ketryx on the All items screen, Traceability module, and Risks module. When managing risks in the Risk module,... (385 words) - [Git Based Configuration Items – Ketryx](/content/support/hc/en-us/sections/23504413661325-git-based-configuration-items/index.html): The purpose of this section is to answer questions related to the Git-based configuration items feature and incorporation of... (81 words) - [How can I make a custom read-only field with a default value appear only for a specific item type in Ketryx? – Ketryx](/content/support/hc/en-us/articles/39870359050509-how-can-i-make-a-custom-read-only-field-with-a-default-value-appear-only-for-a-specific-item-type-in-ketryx.html): When you use the Extra field names setting in Ketryx, any field listed there (and with a value, such as a default) will appear in all... (314 words) - [How can we customize the agents? – Ketryx](/content/support/hc/en-us/articles/37340822307853-how-can-we-customize-the-agents/index.html): In addition to Ketryx's templated AI agents, you can create your own custom agents. Hereare some effective agent prompts you can use when... (176 words) - [How does Ketryx ensure that unique IDs are created for git-based configuration items? – Ketryx](/content/support/hc/en-us/articles/25423143412877-how-does-ketryx-ensure-that-unique-ids-are-created-for-git-based-configuration-items.html): Ketryx assigns a unique identifier to each object using the UUID v4 method. This number is encoded in Crockford Base32, which is... (84 words) - [How do I make a field required? – Ketryx](/content/support/hc/en-us/articles/26302171426061-how-do-i-make-a-field-required/index.html): To make a field required, you must configure the proper advanced setting in Ketryx. As the organization owner, navigate to the advanced... (164 words) - [Can I still use the Github for Jira application with Ketryx? – Ketryx](/content/support/hc/en-us/articles/26429866878989-can-i-still-use-the-github-for-jira-application-with-ketryx.html): Yes. You can still utilize the Github for Jira application with Ketryx. This application is an independent feature that will not impact... (43 words) - [Sign up to Ketryx](/content/support/auth/v3/register/index.html) (57 words) - [How can I integreate with Bitbucket repositories? – Ketryx](/content/support/hc/en-us/articles/21751975235981/index.html): The integration process with Bitbucket varies slightly depending on whether you are working with public or private repositories. Here's a... (275 words) - [Are there any industries that could see particular benefits from these agents? – Ketryx](/content/support/hc/en-us/articles/37341113217677-are-there-any-industries-that-could-see-particular-benefits-from-these-agents.html): Medical Technology and Digital Health companies are clear beneficiaries, particularly those working on: Class II or Class III medical... (208 words) - [Reset your password for Ketryx](/content/support/auth/v3/password/forgot/index.html) (22 words) - [Risk Management – Ketryx](/content/support/hc/en-us/sections/23504341449357-risk-management/index.html): The purpose of this section is to answer questions related to the usage and operations of the Ketryx Lifecycle Management system... (77 words) - [How can I add a private repository? – Ketryx](/content/support/hc/en-us/articles/21757870215181-how-can-i-add-a-private-repository/index.html): For private repositories, you need to add authentication information. This is done on the project settings page, where you can enable... (74 words) - [How do I create a custom item type in Ketryx? – Ketryx](/content/support/hc/en-us/articles/34864380894221-how-do-i-create-a-custom-item-type-in-ketryx.html): Detailed instructions on how to create a custom item type in Ketryx and mapping the custom item to a Jira custom issue type can be found... (53 words) - [How do Ketryx Agents differ from other agents? – Ketryx](/content/support/hc/en-us/articles/37341050279437-how-do-ketryx-agents-differ-from-other-agents.html): Ketryx AI Agents differ from generic AI tools because they operate with the completecontext of your quality system, organization, and... (289 words) - [Why can't I move a ticket item from the in progress state to resolved? – Ketryx](/content/support/hc/en-us/articles/26300603143437-why-can-t-i-move-a-ticket-item-from-the-in-progress-state-to-resolved.html): If you are unable to move a ticket item from the In Progress state to a Resolved state, it is likely that you have not yet assigned a... (70 words) - [How do we get documentation to reflect git-based configuration items? – Ketryx](/content/support/hc/en-us/articles/27851967456781-how-do-we-get-documentation-to-reflect-git-based-configuration-items.html): Release documents are populated with relevant items associated with that release version. In the case of git-based items, versions are... (123 words) - [Why is the Risk edit screen showing errors when I try to save? – Ketryx](/content/support/hc/en-us/articles/32159244862349-why-is-the-risk-edit-screen-showing-errors-when-i-try-to-save.html): If you see errors on the Risk edit screen when trying to save, you are most likely not using the Ketryx default screen or workflow (or... (262 words) - [Why are the changes that I made to advanced settings not syncing in my project? – Ketryx](/content/support/hc/en-us/articles/40768991039245-why-are-the-changes-that-i-made-to-advanced-settings-not-syncing-in-my-project.html): The first thing to consider is if you have made changes to the advanced settings at the organization or project level. Updating... (111 words) - [We currently use team-managed projects. How can I migrate my projects to company-managed? – Ketryx](/content/support/hc/en-us/articles/23553727728141-we-currently-use-team-managed-projects-how-can-i-migrate-my-projects-to-company-managed.html): Please follow the instructions in this Jira support article to migrate your team-managed project to a company-managed... (138 words) - [How can I display Git-based repository Item IDs in my release documents? – Ketryx](/content/support/hc/en-us/articles/36120729247885-how-can-i-display-git-based-repository-item-ids-in-my-release-documents.html): You can include Git-based repository Item IDs in your release documents by adding the {item.repositoryItemId} tag to your document... (172 words) - [Does Ketryx support C# dependency scanning? – Ketryx](/content/support/hc/en-us/articles/34462839525517-does-ketryx-support-c-dependency-scanning.html): Ketryx be used for C# dependency management through integration with external scanners. Here's how: Ketryx can parse SPDX (Software... (108 words) - [Can I use Ketryx to create an agent that connects to a Large Language Model (LLM) via API or MCP to generate documents like grant applications, FDA pre-submission documents, or 60601 testing checklists? Can this agent use my data in Ketryx as well as the – Ketryx](/content/support/hc/en-us/articles/37341151648269-can-i-use-ketryx-to-create-an-agent-that-connects-to-a-large-language-model-llm-via-api-or-mcp-to-generate-documents-like-grant-applications-fda-pre-submission-documents-or-60601-testing-checklists-can-this-agent-use-my-data-in-ketryx-as-well-as-the.html): MCP, or the Model Context Protocol, is an open standard developed by Anthropic to standardize how AI applications provide context to... (183 words) - [What appears in the "Identification of characteristics related to safety" section of the Risk Management File? – Ketryx](/content/support/hc/en-us/articles/22885654914829-what-appears-in-the-identification-of-characteristics-related-to-safety-section-of-the-risk-management-file.html): In Ketryx standard defaults, this section of the Risk Management File will be populated with all design inputs and outputs (RQ, SW, HW)... (176 words) - [Can I link git-based Software Items Specifications to dependencies, in Git? – Ketryx](/content/support/hc/en-us/articles/34058945104909-can-i-link-git-based-software-items-specifications-to-dependencies-in-git.html): Yes. The usedDependencies field allows you to link Software Item Specifications (SWs) to dependencies, using itemID. Once you do this,... (85 words) - [What challenges/industry gaps do these agents seek to address? – Ketryx](/content/support/hc/en-us/articles/37340989195789-what-challenges-industry-gaps-do-these-agents-seek-to-address.html): Time to respond and act based on complaints and emerging cybersecurity threats are the big ones. Today, a single software patch can take... (172 words) - [Which file types from github does Ketryx support? – Ketryx](/content/support/hc/en-us/articles/34639562613005-which-file-types-from-github-does-ketryx-support.html): Ketryx currently supports managing configuration items in the following file formats: Markdown (.md) files (support for all item types)... (85 words) - [Does Ketryx support Git-based risks? – Ketryx](/content/support/hc/en-us/articles/41955656286861-does-ketryx-support-git-based-risks/index.html): Yes, you can create a risk in a .md file in Git, which will be read only in Ketryx. To do this, use the following field keys: Initial... (101 words) - [How can I set up post-market vulnerability notifications for a specific release? – Ketryx](/content/support/hc/en-us/articles/35465739509517-how-can-i-set-up-post-market-vulnerability-notifications-for-a-specific-release.html): From the All Items screen, navigate to Releases on the left-hand side and select a Version you'd like to set-up post-market vulnerability... (111 words) - [How do I write KQL to find items with empty fields? – Ketryx](/content/support/hc/en-us/articles/42928936616717-how-do-i-write-kql-to-find-items-with-empty-fields.html): In order to write KQL to find items where a particular field is empty (empty string matching), the following KQL should be... (65 words) - [How can I generate a Code Change Review (CCR) report in Ketryx? – Ketryx](/content/support/hc/en-us/articles/21748742683533-how-can-i-generate-a-code-change-review-ccr-report-in-ketryx.html): Once set up, the Code Change Review report is available on a project's Code page. To go there, navigate to the project for which a report... (107 words) - [What is the "Reference as a used service" check box for? – Ketryx](/content/support/hc/en-us/articles/39686428032013-what-is-the-reference-as-a-used-service-check-box-for.html): Enable this check box if the referenced project provides services or functionality that your current project depends on, rather than... (92 words) - [Can I connect the agents to my ALM system where I manage requirements? – Ketryx](/content/support/hc/en-us/articles/37341026433293-can-i-connect-the-agents-to-my-alm-system-where-i-manage-requirements.html): Yes! Agents can see data, like requirements, from any system you’ve connected toKetryx, including Jira, Polarion, Jama, and ADO. This... (54 words) - [For mono repositories connecting to Ketryx, can you split depending on what module within a given mono repo? – Ketryx](/content/support/hc/en-us/articles/35519836930061-for-mono-repositories-connecting-to-ketryx-can-you-split-depending-on-what-module-within-a-given-mono-repo.html): Yes. A given Ketryx project can be configured to specifically interact with subsets of a repo. This can be done in a number of ways,... (102 words) - [Why is my custom item type not showing up with default realtions? – Ketryx](/content/support/hc/en-us/articles/40223990284173-why-is-my-custom-item-type-not-showing-up-with-default-realtions.html): Custom Item types do not automatically come with default relations. These can be configured through the custom relations advanced... (60 words) - [Can I use Ketryx to document threat models in my system? – Ketryx](/content/support/hc/en-us/articles/34864644510861-can-i-use-ketryx-to-document-threat-models-in-my-system.html): Ketryx supports threat model documentation using STRIDE (Spoofing, Tampering, Repudiation, Information disclosure, Denial of service,... (64 words) - [Milestones – Ketryx](/content/support/hc/en-us/sections/23504299065997-milestones/index.html): The purpose of this section is to answer questions related to activities that will be performed as part of the development of a product... (28 words) - [Can Ketryx invalidate items that use custom workflows? – Ketryx](/content/support/hc/en-us/articles/30580999441421-can-ketryx-invalidate-items-that-use-custom-workflows.html): Absolutely! As those who use custom workflows may already know, the Approval Workflow advanced setting allows Ketryx users to define the... (133 words) - [How do I exclude items with an 'obsolete' status from Ketryx? – Ketryx](/content/support/hc/en-us/articles/35940769861901-how-do-i-exclude-items-with-an-obsolete-status-from-ketryx.html): If your organization uses an 'obsolete' status name to indicate that an item is no longer relevant to the product, and Ketryx is reading... (112 words) - [How do I map relation names to Ketryx relation types when fetching data from Jira? – Ketryx](/content/support/hc/en-us/articles/35448737563661-how-do-i-map-relation-names-to-ketryx-relation-types-when-fetching-data-from-jira.html): In your organization, head to the advanced settings and find the ‘Relation names’ configuration. (Organization -> Advanced ->... (98 words) - [How do the 'to' and 'from' filters work in a custom document template? – Ketryx](/content/support/hc/en-us/articles/35015216385037-how-do-the-to-and-from-filters-work-in-a-custom-document-template.html): The 'to' and 'from' tags are powerful filters that allow you to look into a related items field values when looping through configuration... (364 words) - [How often does Ketryx backup our data? – Ketryx](/content/support/hc/en-us/articles/26300341624973-how-often-does-ketryx-backup-our-data.html): Ketryx performs daily backups in AWS and data is stored in different regions than the source. All backups are set for long term retention. (34 words) - [How can I use the SOUP dependency analysis feature? – Ketryx](/content/support/hc/en-us/articles/21757716545805-how-can-i-use-the-soup-dependency-analysis-feature.html): Please see our MAN-03 Supply Chain Management documentation for more information on how to use the SOUP dependency analysis feature. (32 words) - [Are the signatures in Jira part 11 compliant or just the final document signatures? – Ketryx](/content/support/hc/en-us/articles/34659561469069-are-the-signatures-in-jira-part-11-compliant-or-just-the-final-document-signatures.html): Ketryx offers the ability to make electronic signatures Part 11 compliant through multi-factor authentication (MFA). This can be applied... (99 words) - [How do I enable AI in Ketryx? – Ketryx](/content/support/hc/en-us/articles/34649814412173-how-do-i-enable-ai-in-ketryx/index.html): Ketryx Intelligence can be enabled or disabled within your organization using the advanced settings menu, as shown below. Some AI... (105 words) - [What is the process for adding a new user to Ketryx? – Ketryx](/content/support/hc/en-us/articles/34650178865805-what-is-the-process-for-adding-a-new-user-to-ketryx.html): To add a new user to Ketryx, there are two main approaches: 1. Inviting users: As an organization member with the "Invite... (188 words) - [How is Ketryx different from JIRA tracking and Bitbucket? – Ketryx](/content/support/hc/en-us/articles/26947571029133-how-is-ketryx-different-from-jira-tracking-and-bitbucket.html): Regulated development teams leverage modern tools like Jira for project tracking, requirement and issue management, and test management.... (620 words) - [How can I integreate with Azure DevOps repositories? – Ketryx](/content/support/hc/en-us/articles/24253538199053-how-can-i-integreate-with-azure-devops-repositories.html): The integration process with Azure DevOps varies slightly depending on whether you are working with public or private repositories.... (195 words) - [Frequently Asked Questions – Ketryx](/content/support/hc/en-us/categories/21249394265741-frequently-asked-questions/index.html) (813 words) - [What is the latest Ketryx version deployed into production? – Ketryx](/content/support/hc/en-us/articles/34382023953933-what-is-the-latest-ketryx-version-deployed-into-production.html): To determine the active version of Ketryx, click on your name in the bottom left corner and look at the top of the menu that pops up. (39 words) - [How can I update my SBOM that I already uploaded through the Ketryx Build API? – Ketryx](/content/support/hc/en-us/articles/35929896326157-how-can-i-update-my-sbom-that-i-already-uploaded-through-the-ketryx-build-api.html): If you uploaded a CycloneDX (CDX) file through the Ketryx Build API, and would like to update the information or add additional... (203 words) - [ What permissions does the Bitbucket Repository Access Token need? – Ketryx](/content/support/hc/en-us/articles/21748245503629-what-permissions-does-the-bitbucket-repository-access-token-need.html): The following permissions are needed for the Code Change Review feature to work: Repository: Read ... (30 words) - [Can I connect a Jira Project to Ketryx and then utilize Ketryx items to build out my Jira project without creating items in Jira? – Ketryx](/content/support/hc/en-us/articles/35458958465165-can-i-connect-a-jira-project-to-ketryx-and-then-utilize-ketryx-items-to-build-out-my-jira-project-without-creating-items-in-jira.html): Yes you can utilize Ketryx items to build out your Jira project! By utilizing the "Enforcer" mode when you create a Ketryx... (167 words) - [Why can't I see my approvals or traceability widget in Jira? – Ketryx](/content/support/hc/en-us/articles/26297818322701-why-can-t-i-see-my-approvals-or-traceability-widget-in-jira.html): Mismatched email addresses One common issue is that your email address for Ketryx may differ from the one you use for Jira. Access to... (245 words) - [How do I create custom fields in Jira and Ketryx? – Ketryx](/content/support/hc/en-us/articles/26759980233741-how-do-i-create-custom-fields-in-jira-and-ketryx.html): If you would like to add custom fields to Ketryx default item types, or custom item types, and have Ketryx read those fields, you can... (754 words) - [If I want a specific approval rule to only apply to certain types of requirements, is that possible and how do I configure Ketryx? – Ketryx](/content/support/hc/en-us/articles/35452024285581-if-i-want-a-specific-approval-rule-to-only-apply-to-certain-types-of-requirements-is-that-possible-and-how-do-i-configure-ketryx.html): Yes, it is possible to apply specific approval rules to subsets of requirements. The key is to apply a Ketryx Query Language (KQL)... (178 words) - [Can I use the Jira External Systems Importer to import my risk items, along with their risk matrices? – Ketryx](/content/support/hc/en-us/articles/36571632331405-can-i-use-the-jira-external-systems-importer-to-import-my-risk-items-along-with-their-risk-matrices.html): Yes, Risk items and their risk matrix values can be imported to Ketryx via Jira's External Systems Importer. The instructions below... (572 words) - [How do you add your repository to Ketryx for an existing project? – Ketryx](/content/support/hc/en-us/articles/21757614969741-how-do-you-add-your-repository-to-ketryx-for-an-existing-project.html): To add your repository to a new project, click here. To add your repository to Ketryx for an existing project: Click into the... (221 words) - [Can Ketryx convert our existing Jira native links to Ketryx custom relational fields? – Ketryx](/content/support/hc/en-us/articles/34638792892685-can-ketryx-convert-our-existing-jira-native-links-to-ketryx-custom-relational-fields.html): Yes, Ketryx can convert existing Jira native links to Ketryx custom relational fields! This can be done in 2 different ways. The first... (298 words) - [How do I set up multifactor authentication (MFA)? – Ketryx](/content/support/hc/en-us/articles/34607326609037-how-do-i-set-up-multifactor-authentication-mfa.html): To set up your Multi-Factor Authentication, in the bottom left corner of the screen, click on your name, then select "Configure... (160 words) - [How can I upload a CycloneDX Artifact through Build API? – Ketryx](/content/support/hc/en-us/articles/34640773879949-how-can-i-upload-a-cyclonedx-artifact-through-build-api.html): In order to upload a CycloneDx Artifact to the Ketryx Build API you will need to make two HTTP requests. In order to complete these HTTP... (230 words) - [Is there a change log available, and can I view the changes made along with the user who made them? – Ketryx](/content/support/hc/en-us/articles/34411839266445-is-there-a-change-log-available-and-can-i-view-the-changes-made-along-with-the-user-who-made-them.html): Yes there is a record history available for every configuration item in Ketryx. If a change is made to an item, whether that item has... (200 words) - [Can I create a new/custom Ketryx relation type for the traceability widget? – Ketryx](/content/support/hc/en-us/articles/35459225997709-can-i-create-a-new-custom-ketryx-relation-type-for-the-traceability-widget.html): Currently Ketryx does not support the creation of custom relation types within our traceability widget. For more information on the... (39 words) - [How can we customize the dropdown options for probabilities and severities in the Ketryx risk management module to match our risk assessment criteria? – Ketryx](/content/support/hc/en-us/articles/30133045593485-how-can-we-customize-the-dropdown-options-for-probabilities-and-severities-in-the-ketryx-risk-management-module-to-match-our-risk-assessment-criteria.html): You can customize the dropdown options for each risk assessment parameter, such as probabilities and severities, within Ketryx's risk... (154 words) - [Is it possible to approve uploaded release documents in Ketryx? – Ketryx](/content/support/hc/en-us/articles/33815532250253-is-it-possible-to-approve-uploaded-release-documents-in-ketryx.html): Yes. Approval of uploaded release documents can be enabled within project settings, under 'Release controls'. The control, 'Require... (71 words) - [How can I quickly find the project I'm looking for? – Ketryx](/content/support/hc/en-us/articles/34659720549133-how-can-i-quickly-find-the-project-i-m-looking-for.html): First, you can use these buttons to change the sort of the projects between alphabetically by name (default) and recently updated: ... (77 words) - [How do I create a Personal Access Token for Azure DevOps? – Ketryx](/content/support/hc/en-us/articles/24253777197325-how-do-i-create-a-personal-access-token-for-azure-devops.html): Please see Azure DevOps's documentation. The scope Code with Read capability should be selected. When entering the authentication... (49 words) - [How can I use the Code Change Review (CCR) feature with Bitbucket? – Ketryx](/content/support/hc/en-us/articles/21748165509645-how-can-i-use-the-code-change-review-ccr-feature-with-bitbucket.html): For Ketryx to fetch Pull Request data from Bitbucket, authentication needs to happen via a Repository Access Token. Access tokens can be... (134 words) - [How do I configure my total probability risk matrix if I do not utilize P1 and P2 values? – Ketryx](/content/support/hc/en-us/articles/35452806088333-how-do-i-configure-my-total-probability-risk-matrix-if-i-do-not-utilize-p1-and-p2-values.html): When doing risk controls, we lookup the total probability of a risk occurring (Ptotal) based off the occurrence probability (P1) and harm... (253 words) - [I connected a Jira project and it changed the icons of my issue types. What do I do now? – Ketryx](/content/support/hc/en-us/articles/35012666964749-i-connected-a-jira-project-and-it-changed-the-icons-of-my-issue-types-what-do-i-do-now.html): If a company-managed Jira project is connected to Ketryx using the "Use Ketryx issue types, screens and workflows" Ketryx... (388 words) - [What types of automated documentation checks, including traceability, are available? – Ketryx](/content/support/hc/en-us/articles/25424500670221-what-types-of-automated-documentation-checks-including-traceability-are-available.html): Ketryx implements a variety of automated documentation checks, or "engineering controls," which are based on traceability, the... (130 words) - [How can I see or export the users in my Ketryx organization? How do I know how many users are in my organization? – Ketryx](/content/support/hc/en-us/articles/34543606818445-how-can-i-see-or-export-the-users-in-my-ketryx-organization-how-do-i-know-how-many-users-are-in-my-organization.html): From any page in Ketryx, on the right sidebar, click on "Organization" and then select "Members" From the members... (130 words) - [Why is my new trace widget link not in a Ketryx custom link field in Jira? – Ketryx](/content/support/hc/en-us/articles/38327414171149-why-is-my-new-trace-widget-link-not-in-a-ketryx-custom-link-field-in-jira.html): This is expected behavior. For example, when you create a child requirement in the traceability widget in Jira, the parent item will show... (98 words) - [How do I generate release documents? – Ketryx](/content/support/hc/en-us/articles/33815271363597-how-do-i-generate-release-documents/index.html): This video walks you through how to generate Release Documents in Ketryx., Use Loom to record quick videos of your screen and cam. Explain anything clearly and easily – and skip the meeting. An essential tool for hybrid workplaces. (90 words) - [How do you add your repository to Ketryx for a new project? – Ketryx](/content/support/hc/en-us/articles/21757485801229-how-do-you-add-your-repository-to-ketryx-for-a-new-project.html): To add your repository for an existing project, click here. To add your repository to Ketryx is during project creation: From the... (216 words) - [How can I use the Code Change Review feature with Azure DevOps? – Ketryx](/content/support/hc/en-us/articles/24253862909197-how-can-i-use-the-code-change-review-feature-with-azure-devops.html): Ketryx does not support Code Change Reviews with Azure DevOps at this time. We are working on adding this feature in the future. Please... (52 words) - [How can I clear my SBOM that I uploaded via the Build API? – Ketryx](/content/support/hc/en-us/articles/35931870276237-how-can-i-clear-my-sbom-that-i-uploaded-via-the-build-api.html): In the case that you would like to restart or reset your SBOM upload via CDX file using the Build API, there is a method that can make... (270 words) - [Does Ketryx provide any documentation mapping ISO 13485, IEC 62304, and ISO 14971 requirements to parts, items, or workflows in Ketryx? – Ketryx](/content/support/hc/en-us/articles/30133016984205-does-ketryx-provide-any-documentation-mapping-iso-13485-iec-62304-and-iso-14971-requirements-to-parts-items-or-workflows-in-ketryx.html): Ketryx provides configurable tools that can be aligned with the requirements of ISO 13485, IEC 62304, and ISO 14971, and we can provide... (174 words) - [Why isn't the Traceability module in Ketryx showing a direct trace to items one-step removed? – Ketryx](/content/support/hc/en-us/articles/34440058415373-why-isn-t-the-traceability-module-in-ketryx-showing-a-direct-trace-to-items-one-step-removed.html): The default configuration for Ketryx's traceability matrix can be found in the project advanced settings (click the question icon next to... (179 words) - [Is Ketryx SOC 2 Type II certified? Is Ketryx SOC 1 and SOC 3 certified? – Ketryx](/content/support/hc/en-us/articles/34459729393165-is-ketryx-soc-2-type-ii-certified-is-ketryx-soc-1-and-soc-3-certified.html): Yes, Ketryx maintains certifications for SOC 2 Type II, SOC 1, and SOC 3. Maintenance of these certifications highlights our ongoing... (60 words) - [How can I use the Code Change Review (CCR) feature with GitHub? – Ketryx](/content/support/hc/en-us/articles/21747786838413-how-can-i-use-the-code-change-review-ccr-feature-with-github.html): For Ketryx to fetch Pull Request data from GitHub, authentication needs to happen via a Personal Access Token. Access tokens can be... (101 words) - [Is there anything I should know before downloading the Ketryx Connector for Jira app from Atlassian Marketplace? – Ketryx](/content/support/hc/en-us/articles/35012116592525-is-there-anything-i-should-know-before-downloading-the-ketryx-connector-for-jira-app-from-atlassian-marketplace.html): After the Ketryx app is installed from Atlassian Marketplace and setup is complete, you will be able to link your existing Jira spaces to... (208 words) - [Does Ketryx have a training matrix to manage training requirements for different users or groups, particularly for an ISO 13485-compliant QMS? Can it be used to manage training for all staff, even those not involved in design and development? – Ketryx](/content/support/hc/en-us/articles/30133127230477-does-ketryx-have-a-training-matrix-to-manage-training-requirements-for-different-users-or-groups-particularly-for-an-iso-13485-compliant-qms-can-it-be-used-to-manage-training-for-all-staff-even-those-not-involved-in-design-and-development.html): Ketryx offers flexibility in assigning and managing training requirements for different users or groups within the organization. Through... (202 words) - [I connected Ketryx to my Jira project. Why aren't I seeing Ketryx configurations and schemes in my project? – Ketryx](/content/support/hc/en-us/articles/35013102072589-i-connected-ketryx-to-my-jira-project-why-aren-t-i-seeing-ketryx-configurations-and-schemes-in-my-project.html): Assuming you have downloaded the Ketryx Connector app from Atlassian Marketplace, Ketryx configurations and schemes (ex. Ketryx Risk... (276 words) - [Could Ketryx personnel add users to groups or add users to the organization for me? – Ketryx](/content/support/hc/en-us/articles/27191589729037-could-ketryx-personnel-add-users-to-groups-or-add-users-to-the-organization-for-me.html): Access to Ketryx, and membership in groups, should be managed and closely monitored by your organization owner. As a general rule, Ketryx... (73 words) - [How do I enable Part 11 multi-factor authentication (MFA) electronic signatures for my organization? – Ketryx](/content/support/hc/en-us/articles/25257664977165-how-do-i-enable-part-11-multi-factor-authentication-mfa-electronic-signatures-for-my-organization.html): To enhance the security of electronic signatures within your organization, you can enable multi-factor authentication (MFA). Follow these... (88 words) - [What determines ‘full traceability’ in the release checklist? – Ketryx](/content/support/hc/en-us/articles/38723354067341-what-determines-full-traceability-in-the-release-checklist.html): The matrix can show 100% completion if all configured traceability checks are fulfilled, even if some items are present as dangling or... (106 words) - [How do I create a Group Access Token for GitLab? – Ketryx](/content/support/hc/en-us/articles/24254145591309-how-do-i-create-a-group-access-token-for-gitlab.html): An alternative to the Personal Access Token is the Group Access Token. Steps on how to create one can be found in GitLab's documentation.... (76 words) - [Where can I find Ketryx validation reports for the Ketryx Platform itself? – Ketryx](/content/support/hc/en-us/articles/34460169025805-where-can-i-find-ketryx-validation-reports-for-the-ketryx-platform-itself.html): You may have received a notification that the platform has updated or the version number on the bottom left-hand-side menu has changed.... (148 words) - [I've added my GitHub repository, but I still can't see the Code Change Review (CCR) Report. What can I do? – Ketryx](/content/support/hc/en-us/articles/21747500582669-i-ve-added-my-github-repository-but-i-still-can-t-see-the-code-change-review-ccr-report-what-can-i-do.html): Follow the below process to make sure you have added an authentication token for your repository in the project settings page. ... (123 words) - [What repository platforms are currently supported? – Ketryx](/content/support/hc/en-us/articles/21757300208781-what-repository-platforms-are-currently-supported.html): Ketryx supports Git repository data fetching for repositories hosted on GitHub, Bitbucket, GitLab and Azure DevOps and any other Git... (49 words) - [I only have one p value - can I remove the other field from the risk screen? – Ketryx](/content/support/hc/en-us/articles/37025513958925-i-only-have-one-p-value-can-i-remove-the-other-field-from-the-risk-screen.html): If you only have one probability value (a single "P" value, rather than separate P1 and P2 values), you can configure your... (159 words) - [Does Ketryx provide validation documentation to its customers? – Ketryx](/content/support/hc/en-us/articles/27195302688013-does-ketryx-provide-validation-documentation-to-its-customers.html): Yes, Ketryx can provide our customers with a full validation package. Ketryx is certified by UL to ISO 13485, ISO 14971, and IEC 62304.... (79 words) - [Can I export all of my data from Ketryx? – Ketryx](/content/support/hc/en-us/articles/33547670469517-can-i-export-all-of-my-data-from-ketryx.html): Yes, Ketryx offers the following options for exporting your data 1. Project Export Mechanism What it does: Generates an archive... (127 words) - [Which rich text formats does Ketryx support? – Ketryx](/content/support/hc/en-us/articles/40473454761229-which-rich-text-formats-does-ketryx-support.html): The limitation of Ketryx's Edit form rich-text fields are noted below.Ketryx's rich-text fields support: Bold: Command+B (for Mac) or... (326 words) - [Do you have any documentation that can help manage compliance to IEC 62366-1 (Usability engineering)? – Ketryx](/content/support/hc/en-us/articles/30133233551885-do-you-have-any-documentation-that-can-help-manage-compliance-to-iec-62366-1-usability-engineering.html): The Ketryx platform is designed to support and document compliance processes for various standards, including IEC 62366-1. Ketryx allows... (206 words) - [Can we add another level in traceability to link System Requirements to Hardware or Software Requirements for more detailed subsystem traceability? – Ketryx](/content/support/hc/en-us/articles/34415657616525-can-we-add-another-level-in-traceability-to-link-system-requirements-to-hardware-or-software-requirements-for-more-detailed-subsystem-traceability.html): Yes, Ketryx provides flexibility in configuring traceability levels and relationships between different types of requirements and... (87 words) - [How do i migrate data into a Ketryx project? – Ketryx](/content/support/hc/en-us/articles/38472623230733-how-do-i-migrate-data-into-a-ketryx-project.html): When you create a new Jira-connected project in Ketryx, you have two options for Jira configurations: Use Ketryx Issue Types, Screens and... (432 words) - [Is Ketryx connected to Jira on a project-by-project basis or is it connected to the entire instance? – Ketryx](/content/support/hc/en-us/articles/24800396609933-is-ketryx-connected-to-jira-on-a-project-by-project-basis-or-is-it-connected-to-the-entire-instance.html): Ketryx integrates with the entire Jira instance. This means that when you create a project in Ketryx, you can choose from any of the... (157 words) - [Why Can’t I Template My Additional Traceability Matrix? – Ketryx](/content/support/hc/en-us/articles/38927655688077-why-can-t-i-template-my-additional-traceability-matrix.html): If you are trying to call an additional traceability matrix in a document template, and it is not showing up, it is likely that your... (101 words) - [How to change resolution field in Jira – Ketryx](/content/support/hc/en-us/articles/39469935708941-how-to-change-resolution-field-in-jira.html): This video explains how to configure Post Functions in a Jira workflow to manage the Resolution field automatically.You will learn how..., In this video, I walk you through the process of enabling post functions for the resolution in our project management tool. I demonstrate how to edit the workflow, specifically focusing on the transition from "Resolved" to "Closed" and then how to clear the resolution field when transitioning back to "Reopen." I also highlight the importance of ensuring the resolution field reflects the correct status during these transitions. Please follow along with the steps I outlined, and make sure to implement these changes in your own workflows. Let me know if you have any questions! (81 words) - [How do I configure Ketryx so that risks are automatically associated and prompt mitigation or reassessment when a requirement or test is updated? – Ketryx](/content/support/hc/en-us/articles/38970797940621-how-do-i-configure-ketryx-so-that-risks-are-automatically-associated-and-prompt-mitigation-or-reassessment-when-a-requirement-or-test-is-updated.html): When requirements or tests are updated, Ketryx can automatically trigger a risk impact assessment. By enabling “Require re-verification... (288 words) - [What permissions are required to delete items in Jira? – Ketryx](/content/support/hc/en-us/articles/24711606205837-what-permissions-are-required-to-delete-items-in-jira.html): To delete Jira issues, it's important to ensure that the appropriate permissions are set correctly within your project. Follow these... (175 words) - [Can I use an external vulnerability scanner and report those results to Ketryx? – Ketryx](/content/support/hc/en-us/articles/37030761075853-can-i-use-an-external-vulnerability-scanner-and-report-those-results-to-ketryx.html): Yes. If you would like to use a vulnerability scanner (outside of the built-in one), report these findings to Ketryx, and subsequently... (114 words) - [How do I create a Project Access Token for GitLab? – Ketryx](/content/support/hc/en-us/articles/21757239552013-how-do-i-create-a-project-access-token-for-gitlab.html): An alternative to the Personal Access Token is the Project Access Token. For instructions on creating a Project Access Token in Gitlab,... (69 words) - [How do I export Jira items for a Ketryx migration? – Ketryx](/content/support/hc/en-us/articles/35192684635277-how-do-i-export-jira-items-for-a-ketryx-migration.html): A key thing to understand about exporting Jira items for a Ketryx migration is that each CSV has to contain fewer than 1000 items. This... (379 words) - [What email account should I use when integrating Ketryx with my other systems? – Ketryx](/content/support/hc/en-us/articles/35449305507213-what-email-account-should-i-use-when-integrating-ketryx-with-my-other-systems.html): We strongly recommend setting up and using a service account with administrator privileges (e.g. ketryx@yourcompany.com) to connect... (152 words) - [How do I generate a table of contents on custom templated documents? – Ketryx](/content/support/hc/en-us/articles/36060719826317-how-do-i-generate-a-table-of-contents-on-custom-templated-documents.html): If you are using one of the Standard Template Files rather than the out of the box documents, you will notice that there is a {@toc}... (240 words) - [Why do systems documents and templated documents have different behavior for prompting re-generation? – Ketryx](/content/support/hc/en-us/articles/37192573748621-why-do-systems-documents-and-templated-documents-have-different-behavior-for-prompting-re-generation.html): System documents require regeneration when any underlying data or configuration items referenced by the document are changed, even if the... (213 words) - [How do I utilize the Jira API to generate identifier numbers for Ketryx select option fields? – Ketryx](/content/support/hc/en-us/articles/37023732119309-how-do-i-utilize-the-jira-api-to-generate-identifier-numbers-for-ketryx-select-option-fields.html): The first thing to do is to determine if the field that you are trying to generate identifier numbers for is a Ketryx field. Ketryx... (182 words) - [How do I add Xray items to Jira and see them in Ketryx? – Ketryx](/content/support/hc/en-us/articles/35191871579277-how-do-i-add-xray-items-to-jira-and-see-them-in-ketryx.html): To add Xray item types to Ketryx in Jira, you'll need to follow a process similar to adding custom item types. Ketryx integrates with... (374 words) - [What is a Fork Release in Ketryx and what can it be used for? – Ketryx](/content/support/hc/en-us/articles/38269808425357-what-is-a-fork-release-in-ketryx-and-what-can-it-be-used-for.html): A fork release in Ketryx refers to creating a new version of a release that branches off from an existing baseline - such as version 1.1... (274 words) - [How does Ketryx validate integrations? – Ketryx](/content/support/hc/en-us/articles/35197205593997-how-does-ketryx-validate-integrations.html): Ketryx offers various integrations with tools like Jira, GitHub, TestRail, Jama, and Xray. All integrations that are part of... (122 words) - [How can I define custom document IDs? – Ketryx](/content/support/hc/en-us/articles/36224248371981-how-can-i-define-custom-document-ids.html): To set a static document ID within your generated documents, you can define a custom template variable (ex. DocId) within advanced... (148 words) - [How can I lock multiple records at once? – Ketryx](/content/support/hc/en-us/articles/37254143228173-how-can-i-lock-multiple-records-at-once.html): Note: Record locks (associating a record with a version explicitly) will take precedence over item exclusion. That is, if I lock a... (181 words) - [Can a System Requirement trace from a Risk, in addition to a parent User Need Requirement, especially when identified during a preliminary risk assessment? – Ketryx](/content/support/hc/en-us/articles/34415439274125-can-a-system-requirement-trace-from-a-risk-in-addition-to-a-parent-user-need-requirement-especially-when-identified-during-a-preliminary-risk-assessment.html): Yes, a System Requirement can trace from a Risk. You can establish this traceability using the traceability widget or its associated... (129 words) - [How can I generate ATs in my templated documents? – Ketryx](/content/support/hc/en-us/articles/37190412367501-how-can-i-generate-ats-in-my-templated-documents.html): ATs in Ketryx are elements that are created when automated tests are reported directly against design items (e.g. RQ or SW), as opposed... (90 words) - [Why does Ketryx introduce custom relation fields rather than using Jira's native links? – Ketryx](/content/support/hc/en-us/articles/21723770012557-why-does-ketryx-introduce-custom-relation-fields-rather-than-using-jira-s-native-links.html): There are two main reasons for this: Native links can go from any issue to any other issue, so you can't restrict the target of a... (222 words) - [What permissions does the GitHub Personal Access Token need? – Ketryx](/content/support/hc/en-us/articles/21747340784269-what-permissions-does-the-github-personal-access-token-need.html): The following permissions are needed for the Code Change Review feature to work. For the classic Personal Access Token,... (53 words) - [How can I rename my Organization or Project? – Ketryx](/content/support/hc/en-us/articles/35467614117901-how-can-i-rename-my-organization-or-project.html): To rename an Organization, click on Organization on the left-hand side of Ketryx, rename your Organization in the Name field, and click... (77 words) - [Why does Ketryx say that I need to reset my MFA? – Ketryx](/content/support/hc/en-us/articles/33154439343501-why-does-ketryx-say-that-i-need-to-reset-my-mfa.html): There are a couple common scenarios where you might encounter a prompt to reset your Multi-Factor Authentication (MFA) in Ketryx: ... (169 words) - [Why are my items in the Resolved state able to be pushed to Closed without signatures for items in Jira? – Ketryx](/content/support/hc/en-us/articles/39987199811469-why-are-my-items-in-the-resolved-state-able-to-be-pushed-to-closed-without-signatures-for-items-in-jira.html): If you are able to move items from a Resolved to Closed state without a signature, it is likely that the workflow in Jira does not have... (114 words) - [Why does a formatted numerical list separated by sections (within the same field) have the numbering reset in Ketryx whereas in Jira the list continues? – Ketryx](/content/support/hc/en-us/articles/39987785321485-why-does-a-formatted-numerical-list-separated-by-sections-within-the-same-field-have-the-numbering-reset-in-ketryx-whereas-in-jira-the-list-continues.html): In Jira, a field can have a formatted numerical list that is separated by different blocks and continue with the numbering like... (109 words) - [What's the difference between Ketryx's Problem Report and Anomaly Report? – Ketryx](/content/support/hc/en-us/articles/37200631209741-what-s-the-difference-between-ketryx-s-problem-report-and-anomaly-report.html): The Problem Report provides a comprehensive overview of anomalies (problems, bugs, defects) associated with a particular software... (101 words) - [How do I update my username in Ketryx? – Ketryx](/content/support/hc/en-us/articles/39412459663629-how-do-i-update-my-username-in-ketryx.html): Updating your username in Ketryx is simple and easy to do. Navigate to your profile in the bottom left-hand corner of the screen, and... (44 words) - [Why am I getting an "Invalid Token" error and delayed verification email when attempting to sign into Ketryx? – Ketryx](/content/support/hc/en-us/articles/39333882889229-why-am-i-getting-an-invalid-token-error-and-delayed-verification-email-when-attempting-to-sign-into-ketryx.html): On occasion, spam filters will click on the linked token in access emails, rendering them invalid for the user. There is a manual token... (71 words) - [Why aren't attachments loading to my excel document template? – Ketryx](/content/support/hc/en-us/articles/37293949628045-why-aren-t-attachments-loading-to-my-excel-document-template.html): Excel is limited in terms of rendering of rich text content, so the templating language for rich text content ({~~renderedContent}),... (64 words) - [Why is the number of Test Cases in the Testing report different from the number of included Test Cases? – Ketryx](/content/support/hc/en-us/articles/39156997011469-why-is-the-number-of-test-cases-in-the-testing-report-different-from-the-number-of-included-test-cases.html): When downloading the Testing report from the Test management page in Ketryx, you can see a different number of Test cases in the report... (265 words) - [What if I did not use a service account to connect an integrated system with Ketryx? – Ketryx](/content/support/hc/en-us/articles/35449916571149-what-if-i-did-not-use-a-service-account-to-connect-an-integrated-system-with-ketryx.html): Currently, switching the connection to a service account (such as ketryx@yourcompany.com) in an established project may cause items to... (84 words) - [How do I troubleshoot issues with Xray? – Ketryx](/content/support/hc/en-us/articles/38339543163277-how-do-i-troubleshoot-issues-with-xray.html): When running into issues with the Xray integration to Ketryx, there are several steps that can be taken to discover missing information... (154 words) - [How do I remove automated tests (ATs) from Ketryx? – Ketryx](/content/support/hc/en-us/articles/37351578161293-how-do-i-remove-automated-tests-ats-from-ketryx.html): If you are reporting automated tests directly against configuration items and not against test cases, the test will appear as 'AT' in the... (96 words) - [Which fields copy from Test Cases to Test Executions when creating executions? – Ketryx](/content/support/hc/en-us/articles/39335984807437-which-fields-copy-from-test-cases-to-test-executions-when-creating-executions.html): When creating Test Executions from Test Cases in Ketryx (either through the Test Management page or via the Jira traceability widget),... (130 words) - [How long will a data deletion request take to be effective? – Ketryx](/content/support/hc/en-us/articles/31173893182733-how-long-will-a-data-deletion-request-take-to-be-effective.html): A data deletion request will be processed and take effect within 7 days from the time of submission. Please reach out to a Ketryx member... (44 words) - [We use a different version numbering system from the default Ketryx numbering (major.minor.patch), how can I configure this? – Ketryx](/content/support/hc/en-us/articles/24545574263309-we-use-a-different-version-numbering-system-from-the-default-ketryx-numbering-major-minor-patch-how-can-i-configure-this.html): To configure your version numbering system, navigate to the advanced project settings and modify the "Version number pattern"... (134 words) - [Do users get email notifications when an assigned item or training document needs approval? – Ketryx](/content/support/hc/en-us/articles/40163730849037-do-users-get-email-notifications-when-an-assigned-item-or-training-document-needs-approval.html): Yes, users will get an email notification from Ketryx@Ketryx.com if they are part of the assigned approval group. If you are not getting... (53 words) - [Can item types or Source IDs be explicitly labeled (e.g., “SYSREQ” for System Requirements, “UNREQ” for User Needs Requirements) instead of the generic “REQ” format? – Ketryx](/content/support/hc/en-us/articles/34416142464141-can-item-types-or-source-ids-be-explicitly-labeled-e-g-sysreq-for-system-requirements-unreq-for-user-needs-requirements-instead-of-the-generic-req-format.html): Yes, Ketryx allows for customization of item types and their labels. There are a couple different ways that this can be achieved through... (192 words) - [Why are my Xray Test steps not showing up or updating in the Ketryx UI? – Ketryx](/content/support/hc/en-us/articles/38339504200205-why-are-my-xray-test-steps-not-showing-up-or-updating-in-the-ketryx-ui.html): If you are looking at your Xray test in Ketryx and the “Steps” field is not populating or not updating there is a high probability that... (231 words) - [I have versions of my product that I have already released and completed migration into Ketryx. How can I use them as a baseline for my Ketryx project? – Ketryx](/content/support/hc/en-us/articles/26003278319373-i-have-versions-of-my-product-that-i-have-already-released-and-completed-migration-into-ketryx-how-can-i-use-them-as-a-baseline-for-my-ketryx-project.html): Congratulations on completing your migration into Ketryx! There are a few ways that you can begin working on your first version of your... (387 words) - [Can I have multiple effective Test Executions for a single Test Case in a version? – Ketryx](/content/support/hc/en-us/articles/35465512632077-can-i-have-multiple-effective-test-executions-for-a-single-test-case-in-a-version.html): By default, Ketryx will only display the most recent Test Execution for a given Test Case in a particular version. The latest Test... (244 words) - [How do you differentiate between test items that are part of verification testing and the ones that belong to validation testing? – Ketryx](/content/support/hc/en-us/articles/23295381290509-how-do-you-differentiate-between-test-items-that-are-part-of-verification-testing-and-the-ones-that-belong-to-validation-testing.html): The main differentiation between test items is the configuration item type that they are testing. Each Requirement requires a test case,... (152 words) - [How do I view the approvals and approval history? – Ketryx](/content/support/hc/en-us/articles/24783872428429-how-do-i-view-the-approvals-and-approval-history.html): The approvals and approval history views vary depending on the type of entity that you are looking for: Version Release Documents... (284 words) - [Why am I having a problem with creating a Xray test execution for a corresponding Xray test plan? – Ketryx](/content/support/hc/en-us/articles/38327703788941-why-am-i-having-a-problem-with-creating-a-xray-test-execution-for-a-corresponding-xray-test-plan.html): A place to start troubleshooting is to see if your Test Plan is in a Closed state. In the closed state, the item is immutable and extends... (176 words) - [How do I exclude test cases in bulk? – Ketryx](/content/support/hc/en-us/articles/35153533337869-how-do-i-exclude-test-cases-in-bulk/index.html): You can exclude test cases in bulk from your release test plan in Ketryx by following these steps: Navigate to the Test management page... (173 words) - [How do I create test executions in bulk? – Ketryx](/content/support/hc/en-us/articles/33736050005005-how-do-i-create-test-executions-in-bulk.html): Test executions can be created in bulk on the Ketryx Test management page. To do so: Select the appropriate version from the version... (96 words) - [Why is my traceability widget not appearing on synced items in Jira? – Ketryx](/content/support/hc/en-us/articles/40768509491981-why-is-my-traceability-widget-not-appearing-on-synced-items-in-jira.html): Your traceability widget may not be appearing because it has not been added to the screen. To make the traceability widget appear on an... (85 words) - [For automated tests in Github, does integration require the project to use a specific syntax or can you work with the conventions the project already uses? Will the integration require us to change how we write automated tests? – Ketryx](/content/support/hc/en-us/articles/23219713701901-for-automated-tests-in-github-does-integration-require-the-project-to-use-a-specific-syntax-or-can-you-work-with-the-conventions-the-project-already-uses-will-the-integration-require-us-to-change-how-we-write-automated-tests.html): For integrating automated tests in GitHub using Ketryx, you will need to add specific annotations (also known as anchors) to your test... (207 words) - [Does Ketryx integrate with Xray? – Ketryx](/content/support/hc/en-us/articles/26312809272461-does-ketryx-integrate-with-xray/index.html): Yes. Ketryx integrates with Xray Test Management for Jira by fetching data from Xray Tests, Test Executions, and Test Plans and mapping... (144 words) - [Are there attributes you can assign to each test case? – Ketryx](/content/support/hc/en-us/articles/23295489004173-are-there-attributes-you-can-assign-to-each-test-case.html): Yes, you can assign attributes to each test. Please see WI-04 for more information. You can fill out the following fields in the ticket: ... (140 words) - [Is it possible to pull test executions from previous releases into the current version? – Ketryx](/content/support/hc/en-us/articles/35464558540301-is-it-possible-to-pull-test-executions-from-previous-releases-into-the-current-version.html): Yes, you can inherit test executions from previous versions and make them effective in the current release test plan. Navigate to the... (85 words) - [Why do my release documents require an update when no changes have been made? – Ketryx](/content/support/hc/en-us/articles/26724869456397-why-do-my-release-documents-require-an-update-when-no-changes-have-been-made.html): When any underlying data changes, even if the document itself remains the same, the system will mark the document as needing... (145 words) - [How do Xray item types compare with Ketryx item types? – Ketryx](/content/support/hc/en-us/articles/35197278347533-how-do-xray-item-types-compare-with-ketryx-item-types.html): Xray item types can be used instead of Ketryx Test Case and Ketryx Test Execution types. For mapping Xray items to Ketryx, the... (178 words) - [How does Ketryx enable users to work on multiple versions and deployments for the same project? – Ketryx](/content/support/hc/en-us/articles/25923740034701-how-does-ketryx-enable-users-to-work-on-multiple-versions-and-deployments-for-the-same-project.html): Multiple versions of the same project may exist at one time and exist in varying states. See MAN-01 Ketryx Lifecycle Management for... (153 words) - [How do I create a Personal Access Token for GitLab? – Ketryx](/content/support/hc/en-us/articles/21757202206989-how-do-i-create-a-personal-access-token-for-gitlab.html): For instructions on creating a Personal Access Token in GitLab, please consult GitLab's official documentation. A personal access token... (67 words) - [How do I configure a Jira project with existing tickets to use the Ketryx-provided issue types, screens, and workflows? – Ketryx](/content/support/hc/en-us/articles/24800375463949-how-do-i-configure-a-jira-project-with-existing-tickets-to-use-the-ketryx-provided-issue-types-screens-and-workflows.html): To configure a Jira project with existing tickets for use with Ketryx, perform the following in the Jira project settings:Under Work... (149 words) - [I See 1/1 approvals on a ticket. However, Jira still says that I need the owner to sign. – Ketryx](/content/support/hc/en-us/articles/23123634481549-i-see-1-1-approvals-on-a-ticket-however-jira-still-says-that-i-need-the-owner-to-sign.html): By default we require that the owner of the ticket approve the item along with the given approval group members, but there are a few... (246 words) - [Why are my tests showing up as 'AT' in the traceability module? – Ketryx](/content/support/hc/en-us/articles/36221006322061-why-are-my-tests-showing-up-as-at-in-the-traceability-module.html): In your traceability matrix, tests showing up with an "AT" abbreviation indicate automated tests that are recognized by Ketryx... (101 words) - [How do Xray items link with other items compared to Jira items? – Ketryx](/content/support/hc/en-us/articles/38339479854349-how-do-xray-items-link-with-other-items-compared-to-jira-items.html): Linking Xray test executions with Xrays tests is done using Xray links. Linking an Xray Test with a specification or requirement (in... (82 words) - [How do you add your repository to Ketryx? – Ketryx](/content/support/hc/en-us/articles/21724627283469-how-do-you-add-your-repository-to-ketryx.html): Please see our SOUP documentation for more information: MAN-03 Supply Chain Management. (23 words) - [Does Ketryx support automated testing in YAML? – Ketryx](/content/support/hc/en-us/articles/34639151796749-does-ketryx-support-automated-testing-in-yaml.html): Ketryx does not currently support automated testing in YAML directly, however you can convert your YAML to a JUnit XML. Additional... (45 words) - [What are the Ketryx default release documents and what are the documents omitted by default? How do I re-include them in my release? – Ketryx](/content/support/hc/en-us/articles/24725335342221-what-are-the-ketryx-default-release-documents-and-what-are-the-documents-omitted-by-default-how-do-i-re-include-them-in-my-release.html): By default, Ketryx includes the following release documents on the "Documents for this version" page: SBoM - SOUP - Software... (136 words) - [What is a cyclic relationship between configuration items? Why won't my traceability widget load? – Ketryx](/content/support/hc/en-us/articles/34237901175565-what-is-a-cyclic-relationship-between-configuration-items-why-won-t-my-traceability-widget-load.html): If the traceability widget does not load, it is possible that you've introduced a cyclic relationship between configuration items. A... (193 words) - [ How could I effectively use change request items in Ketryx? What are some common practices? – Ketryx](/content/support/hc/en-us/articles/24932002281997-how-could-i-effectively-use-change-request-items-in-ketryx-what-are-some-common-practices.html): While the Ketryx organization does not prescribe specific practices for managing your Quality Management System (QMS), we can offer... (176 words) - [ How does Ketryx manage product releases that involve cross-project referencing when different versions are utilized in the subsystem projects? – Ketryx](/content/support/hc/en-us/articles/25923850634893-how-does-ketryx-manage-product-releases-that-involve-cross-project-referencing-when-different-versions-are-utilized-in-the-subsystem-projects.html): Ketryx allows users to define the subsystem project versions that you would like to reference in the system project. In the Settings for..., In this video, I explain how Ketryx deals with releases of products with different systems and integrates different versions. I demonstrate how users can define the version of the subsystem reference project in the version settings of the system project. I also show how to reference multiple projects and select specific versions for each project. No action is requested from the viewers. (108 words) - [How can I make document templates require approval? – Ketryx](/content/support/hc/en-us/articles/25907988118285-how-can-i-make-document-templates-require-approval.html): By default, document templates are automatically included in your list of release documents without needing to be in a controlled state.... (46 words) - [Are the tests in the sample project that Ketryx provided manually created? Most of them do not have steps or expected behavior. – Ketryx](/content/support/hc/en-us/articles/22846789441037-are-the-tests-in-the-sample-project-that-ketryx-provided-manually-created-most-of-them-do-not-have-steps-or-expected-behavior.html): Yes, the tests in the sample project provided by Ketryx are manually created. The project isn't intended to mirror a real-life product,... (98 words) - [General – Ketryx](/content/support/hc/en-us/sections/21249394289421-general/index.html) (701 words) - [Does Ketryx have an automated mechanism to send documents from one system to another once they are approved? – Ketryx](/content/support/hc/en-us/articles/25812045910157-does-ketryx-have-an-automated-mechanism-to-send-documents-from-one-system-to-another-once-they-are-approved.html): As of April 11, 2024, Ketryx does not currently have a feature that automatically sends documents from one system to another upon... (76 words) - [Can I access the record of a deleted document in Ketryx? – Ketryx](/content/support/hc/en-us/articles/41897282258957-can-i-access-the-record-of-a-deleted-document-in-ketryx.html): Yes, you may access the record of a deleted document from the Approval history page (Verification & Validation > History or..., Use Loom to record quick videos of your screen and cam. Explain anything clearly and easily – and skip the meeting. An essential tool for hybrid workplaces. (144 words) - [How can I re-include excluded items? – Ketryx](/content/support/hc/en-us/articles/32201555982349-how-can-i-re-include-excluded-items/index.html): You may have accidentally excluded an item from Ketryx and need to bring it back into the Ketryx framework. By default, excluded items... (83 words) - [How can I see which items need to be approved by a specific group? – Ketryx](/content/support/hc/en-us/articles/28062802170125-how-can-i-see-which-items-need-to-be-approved-by-a-specific-group.html): You may want to consider using a KQL search to find which items need to be approved by a specific group. First, filter for items that... (125 words) - [I have a requirement that says "Validation test case missing" even though I have it linked to a software item spec and a test case. What am I missing? – Ketryx](/content/support/hc/en-us/articles/21815382784525-i-have-a-requirement-that-says-validation-test-case-missing-even-though-i-have-it-linked-to-a-software-item-spec-and-a-test-case-what-am-i-missing.html): It is likely that you also need to link the test case to the requirement too if you feel like the test case covers both the specification... (104 words) - [How can I lock items for a release baseline? – Ketryx](/content/support/hc/en-us/articles/33980143806861-how-can-i-lock-items-for-a-release-baseline.html): The methods to lock an item's record or groups of item records for a particular release baseline and the use cases for each method, can... (49 words) - [Do I have to use the provided Ketryx scheme for issue types? – Ketryx](/content/support/hc/en-us/articles/21723743572365-do-i-have-to-use-the-provided-ketryx-scheme-for-issue-types.html): Ketryx maintains four predefined issue type schemes for common use cases, based on the full schema with all the Ketryx item types. If... (94 words) - [How can I integrate with GitLab repositories? – Ketryx](/content/support/hc/en-us/articles/21757186846733-how-can-i-integrate-with-gitlab-repositories.html): The integration process with GitLab varies slightly depending on whether you are working with public or private repositories. Here's a... (186 words) - [Can I link a Change Request to a Document at the Organization-level? – Ketryx](/content/support/hc/en-us/articles/42054275357709-can-i-link-a-change-request-to-a-document-at-the-organization-level.html): Yes, you can achieve this in a similar manner to linking these items on the project-level. After enabling "Documents as Items",... (174 words) - [Test Management – Ketryx](/content/support/hc/en-us/sections/23504319782157-test-management/index.html): The purpose of this section is to answer questions related to the setup and processes for managing both manual and automated tests with... (335 words) - [Why am I unable to access or sign off on a ticket in Jira using the approvals widget? – Ketryx](/content/support/hc/en-us/articles/24572186980493-why-am-i-unable-to-access-or-sign-off-on-a-ticket-in-jira-using-the-approvals-widget.html): There could be a few different reasons for why you may be unable to access or sign off on a ticket in Jira using the approvals widget. ... (750 words) - [Where do I find the approve test plan button? – Ketryx](/content/support/hc/en-us/articles/39360075974157-where-do-i-find-the-approve-test-plan-button.html): You can approve a test plan in Ketryx using the green Approve button in the right sidebar of the Test Management page. If you cannot find... (86 words) - [Can I archive document templates or store drafts somewhere in Ketryx? – Ketryx](/content/support/hc/en-us/articles/34633672962573-can-i-archive-document-templates-or-store-drafts-somewhere-in-ketryx.html): Documents placed in a subfolder within the "Milestone," "Release," or "System" folders under... (169 words) - [What code change review (CCR) platforms are currently supported? – Ketryx](/content/support/hc/en-us/articles/21724098035597-what-code-change-review-ccr-platforms-are-currently-supported.html): Ketryx supports Code Change Review (CCR) data fetching for repositories hosted on GitHub and Bitbucket. If you need... (44 words) - [What is the difference between organization permissions and project permissions in Ketryx? – Ketryx](/content/support/hc/en-us/articles/23737125849741-what-is-the-difference-between-organization-permissions-and-project-permissions-in-ketryx.html): Organization permissions apply across the entire Ketryx organization, while project permissions are specific to individual projects.... (199 words) - [How are Change Requests approved in Ketryx—are tickets closed upon approval, and does this happen in the CR or test plan? Can we customize the process to support significance review with fields or workflows as needed? – Ketryx](/content/support/hc/en-us/articles/38159398464653-how-are-change-requests-approved-in-ketryx-are-tickets-closed-upon-approval-and-does-this-happen-in-the-cr-or-test-plan-can-we-customize-the-process-to-support-significance-review-with-fields-or-workflows-as-needed.html): In Ketryx, the order of approving Change Requests (CRs) and affected items depends on your organization's chosen process and risk... (327 words) - [Who is able to approve milestone documents? How do you control who is able to approve milestone documents? Why can't I approve a milestone document? – Ketryx](/content/support/hc/en-us/articles/28313689339533-who-is-able-to-approve-milestone-documents-how-do-you-control-who-is-able-to-approve-milestone-documents-why-can-t-i-approve-a-milestone-document.html): If you are unable to approve a milestone document, you likely aren't a member of the appropriate approval group. From the project,... (231 words) - [How do I delete a configuration item? – Ketryx](/content/support/hc/en-us/articles/23563907210509-how-do-i-delete-a-configuration-item.html): Before deleting a configuration item from Jira and Ketryx, it is important to ask the question: Is this configuration item obsolete or... (294 words) - [What are long-lived and point-wise (short-lived) configuration items? What are the differences between the two? – Ketryx](/content/support/hc/en-us/articles/23226084383501-what-are-long-lived-and-point-wise-short-lived-configuration-items-what-are-the-differences-between-the-two.html): Long-lived items have a lifespan that spans multiple versions, from their introduction to their obsolescence, while point-wise items are... (229 words) - [For a software item specification, what is the purpose of the "Input" and "Output" field in Jira? – Ketryx](/content/support/hc/en-us/articles/21835209245453-for-a-software-item-specification-what-is-the-purpose-of-the-input-and-output-field-in-jira.html): The input / output field could be used as a field to exhibit the necessary inputs within a specification and how these inputs are... (85 words) - [How is version control ensured for configuration items defined in Jira? – Ketryx](/content/support/hc/en-us/articles/25421173316877-how-is-version-control-ensured-for-configuration-items-defined-in-jira.html): Ketryx maintains a validated connection to Jira's API, ensuring a comprehensive history of changes for each item and a Part 11-compliant... (65 words) - [Can Ketryx only track parts of a project? – Ketryx](/content/support/hc/en-us/articles/28874563441037-can-ketryx-only-track-parts-of-a-project.html): Also: Is it possible to only sync part of a Jira project data to Ketryx? Yes, it is possible to have Ketryx only track parts of a... (159 words) - [I'm using the AI generated summary in my release document template, why am I not getting a response? – Ketryx](/content/support/hc/en-us/articles/29723473871757-i-m-using-the-ai-generated-summary-in-my-release-document-template-why-am-i-not-getting-a-response.html): If you are using the AI generated summary, and the summary is not showing up in your generated release documentation, there may be a few... (283 words) - [Why is my item unexpectedly being moved back to Resolved after being approved? – Ketryx](/content/support/hc/en-us/articles/43983611153549-why-is-my-item-unexpectedly-being-moved-back-to-resolved-after-being-approved.html): SummaryIf an item is unexpectedly moved back to Resolved after being approved, one possible cause is a Jira workflow restriction... (405 words) - [Do Ketryx support Typescript/front end vulnerability checks? – Ketryx](/content/support/hc/en-us/articles/21703837331853-do-ketryx-support-typescript-front-end-vulnerability-checks.html): Yes, we scan for vulnerabilities in JavaScript/TypeScript dependencies listed in package.json, and – if available – package-lock.json and... (52 words) - [How do I get the Approvals and Traceability widgets to show in Jira for non-default issue types? – Ketryx](/content/support/hc/en-us/articles/35042816103053-how-do-i-get-the-approvals-and-traceability-widgets-to-show-in-jira-for-non-default-issue-types.html): The Approvals and Traceability widgets are powerful features of the Ketryx-Jira integration. For Ketryx default issue types, they will be... (347 words) - [When during the product lifecycle should change controls be implemented? Are they required for prototypes, version updates, or patch releases? – Ketryx](/content/support/hc/en-us/articles/38158997098381-when-during-the-product-lifecycle-should-change-controls-be-implemented-are-they-required-for-prototypes-version-updates-or-patch-releases.html): Change controls should be implemented whenever there is a proposed change to any aspect of a regulated product, process, or system that... (75 words) - [What is the difference between a set of incorporated and referenceable items? – Ketryx](/content/support/hc/en-us/articles/29765009984141-what-is-the-difference-between-a-set-of-incorporated-and-referenceable-items.html): Manual-01 Section 5.7 explains the difference between incorporated and referenceable items for project referencing. However, let's... (158 words) - [Can I use Epics and Stories as Design items? – Ketryx](/content/support/hc/en-us/articles/33506167467661-can-i-use-epics-and-stories-as-design-items.html): Most users are familiar with Jira’s issue types of Epics, Stories, Tasks. Epics and Stories focus on what the software needs to achieve...., In this video, I discuss how we can use JIRA and Ketryx to meet federal regulations and international standards in medical device software development. I highlight the importance of using a dedicated requirement issue type in our process to ensure clarity and compliance. I also provide a solution for those who want to continue using epics and stories for project management. By leveraging these tools, we can enhance traceability and effectively manage design controls. Watch the video to learn more and take action to improve our software development process. (446 words) - [Why don't I see an approval button for my release documentation? – Ketryx](/content/support/hc/en-us/articles/31298523093773-why-don-t-i-see-an-approval-button-for-my-release-documentation.html): Figure 1 - User is unable to see an approval button Figure 2 - User is able to see an approval button The reason you don't see the... (251 words) - [Cross Project Referencing – Ketryx](/content/support/hc/en-us/articles/26314705704973-cross-project-referencing/index.html): In this training session, Client Operations Manager, Lee Chickering, will explain how Ketryx can manage a system of systems by creating..., In this training session, I will explain how Ketryx can manage a system of systems by creating cross-project references. We will explore what a system of systems is and how to set up cross-project referencing. I will also discuss the benefits of using an SOS approach and the importance of maintaining clear cross-project references. No action is requested from viewers, but this information is crucial for understanding the capabilities of Ketryx. (86 words) - [Is it possible to manage branched requirements in Ketryx? – Ketryx](/content/support/hc/en-us/articles/27782102664845-is-it-possible-to-manage-branched-requirements-in-ketryx.html): Yes, there are several ways make managing branched requirements possible in Ketryx. 1. You can utilize the Change Request Item Type... (191 words) - [How can we manage projects in a way that gives devs additional information on how to perform an implementation that will not show up in our regulatory submission? – Ketryx](/content/support/hc/en-us/articles/25923965069325-how-can-we-manage-projects-in-a-way-that-gives-devs-additional-information-on-how-to-perform-an-implementation-that-will-not-show-up-in-our-regulatory-submission.html): You could utilize the “Task” configuration item. The task can be traced back to the requirements, specifications, CAPAs, etc and define... (72 words) - [Is the release version in Jira the same as the one in Ketryx? – Ketryx](/content/support/hc/en-us/articles/26344861778445-is-the-release-version-in-jira-the-same-as-the-one-in-ketryx.html): Yes, the release version used in Jira is identical to that in Ketryx. Both platforms maintain alignment with the release versions... (157 words) - [How do I remove unrelated test cases from my requirements traceability matrix? – Ketryx](/content/support/hc/en-us/articles/29915156792461-how-do-i-remove-unrelated-test-cases-from-my-requirements-traceability-matrix.html): Depending on your organizational practices, you may have test cases captured by Ketryx that you don't want reported in your traceability... (106 words) - [Software Release Process – Ketryx](/content/support/hc/en-us/sections/23504213941773-software-release-process/index.html): The purpose of this section is to answer questions related to the activities that will be performed as part of the release of a product... (362 words) - [What is the relation between requirements and specifications? How should I differentiate and manage requirements and specifications? – Ketryx](/content/support/hc/en-us/articles/21784414749837-what-is-the-relation-between-requirements-and-specifications-how-should-i-differentiate-and-manage-requirements-and-specifications.html): Specifications and requirements are closely related but serve different purposes in the design and development process. Requirements are... (447 words) - [How do I create and organize my Architecture Diagram in Ketryx. Why would I need it? – Ketryx](/content/support/hc/en-us/articles/23333041443085-how-do-i-create-and-organize-my-architecture-diagram-in-ketryx-why-would-i-need-it.html): An architecture diagram is a vital tool in various fields such as software development, system engineering, and organizational design,... (406 words) - [How do I ensure my Test Cases are controlled before I create Test Executions? – Ketryx](/content/support/hc/en-us/articles/42083084386317-how-do-i-ensure-my-test-cases-are-controlled-before-i-create-test-executions.html): To ensure my Test Cases are controlled before you execute your Tests, You can use the "Require Test Executions after controlled Test... (115 words) - [When are Change Requests, CAPAs, Anomalies, and Complaints included in the Change Management File – Ketryx](/content/support/hc/en-us/articles/38204865124493-when-are-change-requests-capas-anomalies-and-complaints-included-in-the-change-management-file.html): Change Requests, CAPAs, Anomalies, and Complaints are included in the Change Management File (CMF) only when they affect or are related... (184 words) - [Does Ketryx show cross-referenced items in the requirements traceability matrix (RTM)? If so, how do I enable this? – Ketryx](/content/support/hc/en-us/articles/24478467423629-does-ketryx-show-cross-referenced-items-in-the-requirements-traceability-matrix-rtm-if-so-how-do-i-enable-this.html): Ketryx does support cross-referenced items in the RTM. However, you will need to ensure that you are using the proper traceability... (280 words) - [How to review Item Records in Ketryx – Ketryx](/content/support/hc/en-us/articles/43787961103117-how-to-review-item-records-in-ketryx.html): The video below describes how you can view changes to an item over it's entire lifecycle in Ketryx., In this video, I walk through how to review records of an item in Ketrix, specifically focusing on a closed sample test case in Jira. I demonstrate how to access the approval details, view item history, and compare different versions of records to identify changes. I also show how to add a risk control and link it to an existing risk, which impacts the record by creating a new entry. Finally, I highlight the importance of reviewing test cases when their scope expands due to new requirements. Please make sure to follow these steps when managing your records. (108 words) - [How could I create and manage requirements, software item specifications, and V&V tests in Ketryx? – Ketryx](/content/support/hc/en-us/articles/24718797372173-how-could-i-create-and-manage-requirements-software-item-specifications-and-v-v-tests-in-ketryx.html): Managing requirements, software item specifications, and Verification and Validation (V&V) tests is a critical aspect of software... (1,284 words) - [SBOM Transitive Dependencies – Ketryx](/content/support/hc/en-us/articles/26050081479565-sbom-transitive-dependencies/index.html): In this video, Client Operations Manager, Carlton O'Neal explains how version 2.6 of Ketryx added support for transitive dependencies and..., In this video, I explain how version 2.6 of our contract added support for transitive dependencies and the generation of S-Bombs. I demonstrate how to populate the dependencies screen using our build API and show how transitive dependencies are displayed. I also highlight the vulnerability reporting feature and how it connects with risk management processes. No action is requested from viewers, but this video provides important information on managing dependencies and vulnerabilities. (85 words) - [What if I attempt to approve an item from the All Items screen, I go through the approval process, and then the item remains unapproved? – Ketryx](/content/support/hc/en-us/articles/35450683475469-what-if-i-attempt-to-approve-an-item-from-the-all-items-screen-i-go-through-the-approval-process-and-then-the-item-remains-unapproved.html): In this case, it is likely that Ketryx is blocking approval of the item because an upstream item is uncontrolled. This is particularly... (257 words) - [What is a configuration item? – Ketryx](/content/support/hc/en-us/articles/24714544841357-what-is-a-configuration-item/index.html): IEC 62304 states: Configuration Item Entity that can be uniquely identified at a given reference point. This could be any item defined by... (64 words) - [What is the difference between "used" relationship versus a "parent" relationship? – Ketryx](/content/support/hc/en-us/articles/23125396430093-what-is-the-difference-between-used-relationship-versus-a-parent-relationship.html): The easiest way to distinguish the difference between these two types of relationships is based on the structure within a system or... (138 words) - [Would I still be in compliance if I have the "require automated test to be associated with test cases" setting disabled? – Ketryx](/content/support/hc/en-us/articles/21763256309389-would-i-still-be-in-compliance-if-i-have-the-require-automated-test-to-be-associated-with-test-cases-setting-disabled.html): For further information on this setting see MAN-06 Test Management Section 3.4 here. You may still be in compliance if this setting is... (133 words) - [Can I approve items in bulk? – Ketryx](/content/support/hc/en-us/articles/30243266597517-can-i-approve-items-in-bulk/index.html): Yes! By selecting multiple checkboxes for items that are ready for approval, you will be presented with the option to approve multiple... (79 words) - [Ketryx Lifecycle Management – Ketryx](/content/support/hc/en-us/sections/23504074016269-ketryx-lifecycle-management/index.html): The purpose of this section is to answer questions related to the ongoing usage and operations of the Ketryx Platform, a lifecycle... (414 words) - [What is the difference between a Software Item Spec and a Task in Ketryx? – Ketryx](/content/support/hc/en-us/articles/36096197226125-what-is-the-difference-between-a-software-item-spec-and-a-task-in-ketryx.html): What is a Software Item Spec in Ketryx? A Software Item Spec is a configuration item that describes how a system or software will meet... (310 words) - [What is a "use case"? – Ketryx](/content/support/hc/en-us/articles/21762354592653-what-is-a-use-case/index.html): 21 CFR 820.30g states: "Design validation shall ensure that devices conform to defined user needs and intended uses..."... (245 words) - [Does Ketryx support third-party Jira fields? – Ketryx](/content/support/hc/en-us/articles/42743586493581-does-ketryx-support-third-party-jira-fields.html): Ketryx can read and display many third-party Jira fields.However, support for creating or updating these fields depends on how the Jira... (405 words) - [How can I save edited approval rules so they don't revert to the default approval once a document is transitioned to the close state? – Ketryx](/content/support/hc/en-us/articles/38406994807437-how-can-i-save-edited-approval-rules-so-they-don-t-revert-to-the-default-approval-once-a-document-is-transitioned-to-the-close-state.html): In Ketryx, item-level approval rules are reset whenever an item leaves the "Closed" state, reverting to the default approval... (147 words) - [Does Ketryx take into account and record prior ticket history in Jira? – Ketryx](/content/support/hc/en-us/articles/27485694607501-does-ketryx-take-into-account-and-record-prior-ticket-history-in-jira.html): Example: If I have multiple years of historical changes to a ticket, will Ketryx capture that history and make it available for view in... (87 words) - [Is it possible to create a Ketryx project before creating a Jira project? – Ketryx](/content/support/hc/en-us/articles/25525240848269-is-it-possible-to-create-a-ketryx-project-before-creating-a-jira-project.html): It is possible to create a Ketryx project before creating a Jira project. However, you will not be able to connect a Jira project to the... (115 words) - [How can I rename fields in the Ketryx schema? – Ketryx](/content/support/hc/en-us/articles/21723799904141-how-can-i-rename-fields-in-the-ketryx-schema.html): To rename fields, you can use the advanced setting Field names in the Ketryx organization configuration. Note that... (149 words) - [How do Ketryx's Testing Features Compare to Xray's? – Ketryx](/content/support/hc/en-us/articles/40655535598477-how-do-ketryx-s-testing-features-compare-to-xray-s.html): Ketryx is well-integrated with Xray and clients can continue to use Xray for test management. However, here is how Ketryx Test Management... (183 words) - [How can I use Ketryx for ISO 13485 compliance? – Ketryx](/content/support/hc/en-us/articles/34352253786893-how-can-i-use-ketryx-for-iso-13485-compliance.html): To achieve ISO 13485 compliance, it's necessary to have a comprehensive quality management system (QMS) that covers documentation, risk... (385 words) - [How does the requirements traceability matrix (RTM) work? How do I complete my RTM? – Ketryx](/content/support/hc/en-us/articles/26435535693581-how-does-the-requirements-traceability-matrix-rtm-work-how-do-i-complete-my-rtm.html): The requirements traceability matrix is created based on relationships between the following configuration items: Requirements... (147 words) - [Why can't I exclude items that are incorporated from another project through cross-project referencing? – Ketryx](/content/support/hc/en-us/articles/43088864761997-why-can-t-i-exclude-items-that-are-incorporated-from-another-project-through-cross-project-referencing.html): If your project incorporates items from another project through cross-project referencing, you can only exclude those items in their home... (115 words) - [How Can I Filter Items by Status and Approval on the All Items Page? – Ketryx](/content/support/hc/en-us/articles/35018232348301-how-can-i-filter-items-by-status-and-approval-on-the-all-items-page.html): The All Items page in Ketryx allows you to filter items based on their status, making it easy to track progress and approvals. Here’s how..., Use Loom to record quick videos of your screen and cam. Explain anything clearly and easily – and skip the meeting. An essential tool for hybrid workplaces. (250 words) - [What options are available for documentation publication? – Ketryx](/content/support/hc/en-us/articles/25424554787469-what-options-are-available-for-documentation-publication.html): Currently, we support exporting documents in Word, Excel, and PDF formats. (21 words) - [What are unchecked items? – Ketryx](/content/support/hc/en-us/search/click/index.html): Unchecked items are items that do not need to be controlled before release. The "Require controlled items" release control... (160 words) - [How does Ketryx update users on new features? – Ketryx](/content/support/hc/en-us/articles/35720948896653-how-does-ketryx-update-users-on-new-features.html): Users can receive emailed release notes when new versions come out or the information can be accessed as Product Updates on our blog. ... (61 words) - [Can I defer Anomalies in Ketryx? – Ketryx](/content/support/hc/en-us/articles/30873195482253-can-i-defer-anomalies-in-ketryx/index.html): Yes! You can either use the default functionality of the deferral system or configure it for yourself. Before describing those options,... (300 words) - [Ketryx Lifecycle Management – Ketryx](/content/support/hc/en-us/sections/26048690192013-ketryx-lifecycle-management/index.html) (13 words) - [Supply Chain Management: Software Dependencies – Ketryx](/content/support/hc/en-us/sections/26048713121037-supply-chain-management-software-dependencies.html) (13 words) - [How do I integrate Ketryx with Jira? – Ketryx](/content/support/hc/en-us/articles/21720210269965-how-do-i-integrate-ketryx-with-jira/index.html): To install the Ketryx app in Jira, you need to have administrative privileges on the Jira organization and the Manage connections... (160 words) - [How do I contact Ketryx Support? – Ketryx](/content/support/hc/en-us/articles/22958352145421-how-do-i-contact-ketryx-support/index.html): This article describes the different ways you can contact Ketryx Support and what information you should include.At support.ketryx.com,... (196 words) - [How should I use this FAQ page? – Ketryx](/content/support/hc/en-us/articles/26298717325965-how-should-i-use-this-faq-page/index.html): Thank you for visiting the Ketryx FAQ page. Today, I will guide you on how to navigate this resource effectively. Upon arriving at the..., In this video, I will guide you on how to effectively navigate the Ketryx's FAQ page. I will show you the three main sections: videos, frequently asked questions, and announcements. The videos section provides training and helpful videos tailored to the Ketryx platform. The FAQs section organizes common questions under different categories. Lastly, the announcements section keeps you updated on the latest developments. To navigate the FAQs efficiently, I recommend using the digital assistant located at the bottom right corner of your screen. Watch this video to learn more! (221 words) - [For Git-based configuration items, how does Ketryx ensure bidirectional traceability between items? – Ketryx](/content/support/hc/en-us/articles/25423420246797-for-git-based-configuration-items-how-does-ketryx-ensure-bidirectional-traceability-between-items.html): In Ketryx, relationships between configuration items are inherently bidirectional but not symmetrical. This means that traceability is... (98 words) - [Why do my automatic test executions appear blank or seem like they disappeared? – Ketryx](/content/support/hc/en-us/articles/23749797125645-why-do-my-automatic-test-executions-appear-blank-or-seem-like-they-disappeared.html): Ensure automated tests are reported to the latest, effective build. If your test executions in Ketryx suddenly appear blank, it may be... (149 words) - [Videos – Ketryx](/content/support/hc/en-us/categories/26048701409165-videos/index.html) (24 words) - [Ketryx](/content/demo/auth/signup/index.html): Develop Fast, Stay Compliant. (109 words) - [Search results – Ketryx](/content/support/hc/en-us/search/index.html) (137 words) - [When I go to my projects dashboard, I no longer see my project. Where is it? How do I switch between organizations? – Ketryx](/content/support/hc/en-us/articles/21815027914893-when-i-go-to-my-projects-dashboard-i-no-longer-see-my-project-where-is-it-how-do-i-switch-between-organizations.html): You're likely in multiple Ketryx organizations, so you may need to switch to the correct one. You can do this by: 1. Clicking your name... (172 words) - [Ketryx](/content/app/auth/signup/index.html): Develop Fast, Stay Compliant. (109 words) - [Can I produce different documents for different regulatory regions from the same design controls in the same project? – Ketryx](/content/support/hc/en-us/articles/34983277525133-can-i-produce-different-documents-for-different-regulatory-regions-from-the-same-design-controls-in-the-same-project.html): Ketryx supports producing different documents for different regulatory regions from the same design controls within a single project...., In this video, I demonstrate how to effectively use the regions feature in Kettrix to manage different document versions for various regulatory regions. I outline three specific requirements: one applicable to both the EU and US, one for the EU only, and one for the US only. I also show how to set up these regions in the project settings and link related requirements for better visibility. Please make sure to follow along and implement these changes in your projects. (285 words) - [Ketryx](/content/support/hc/en-us/index.html) (131 words) - [What are the benefits of using a system of system approach? What is a System of Systems? – Ketryx](/content/support/hc/en-us/articles/25923379589389-what-are-the-benefits-of-using-a-system-of-system-approach-what-is-a-system-of-systems.html): What is a System of Systems? A System of Systems (SoS), or using microservices, is an architectural approach in which multiple... (438 words) - [Why does the “Documents approved” field in the release checklist show as completed when my generated documents are not approved? – Ketryx](/content/support/hc/en-us/related/click/index.html): If your generated documents have not been approved and the release checklist shows “Documents approved” as completed, there is likely a... (131 words) - [Submit a request – Ketryx](/content/support/hc/en-us/requests/new/index.html) (96 words) - [Page Not Found - Ketryx Compliance Framework](/content/learn/webinars/register/transitioning-from-monolithic-to-micr-e2-80-a6-ices-how-to-adopt-a-systems-of-systems-approach-for-your-sdlc.html) (9 words) - [blog/a-complete-guide-to-the-fdas-ai-ml-guidance-for-medical-devices.html](/content/blog/a-complete-guide-to-the-fdas-ai-ml-guidance-for-medical-devices.html) (970 words) - [2023 FDA Warning Letters and Software Validation](/content/blog/2023-fda-warning-letters-and-software-validation/index.html): New FDA warning letters for medical devices, medical device software, and other regulated software processes illustrates the FDA's new approach to submissions and audits with new 2023 FDA guidances. (1,689 words) - [Agile in Theory, Waterfall in Practice: Why Regulated Teams Struggle to Ship Fast](/content/blog/agile-in-theory-waterfall-in-practice-why-regulated-teams-struggle-to-ship-fast.html): Learn how medical device software teams can use an agile approach to documentation and product development while staying compliant. (879 words) - [Videos - Ketryx](/content/learn/videos/index.html) (248 words) - [Professional Services](/content/capabilities/professional-services/index.html): Learn about the professional services offered by the Ketryx team, used by Fortune 500 life science companies to accelerate product innovation., In this video, I walk you through how to build an anomaly scoping agent in the Catrix platform to proactively analyze bugs and their potential impacts on our project. We've heard from many of you that triaging bugs can be quite challenging, especially regarding their influence on requirements and design controls. By creating a custom agent, we can assess anomalies from our development history and understand their effects on various system components. I demonstrate this process using an existing agent that analyzed two anomalies, providing a detailed report on their impacts. I encourage you to explore this feature to help your teams make more informed decisions before our next release., Use Loom to record quick videos of your screen and cam. Explain anything clearly and easily – and skip the meeting. An essential tool for hybrid workplaces., Use Loom to record quick videos of your screen and cam. Explain anything clearly and easily – and skip the meeting. An essential tool for hybrid workplaces., Hi there! In this video, I’m excited to show you how our Kettrix AI Requirement Conflict Agent works. We’ll explore how it identifies and resolves conflicting requirements, using a hypothetical insulin delivery system as an example. I’ll walk you through the agent's workflow, including its recommendations for resolving conflicts. Please take a moment to review the findings and consider how this can streamline your processes., Use Loom to record quick videos of your screen and cam. Explain anything clearly and easily – and skip the meeting. An essential tool for hybrid workplaces., Hi there! In this video, I’m excited to show you how our Ketrix AI agent, specifically the Change Request Review agent, works to enhance the change request process. We’ll explore how it identifies incomplete requests and provides recommendations, which can save you significant time and effort. I encourage you to consider how this tool can help streamline your workflow and reduce documentation time by up to 90%. Let’s dive in!, Hi there! In this video, I’m excited to show you how our Kettrix AI Test Coverage agent works. It scans your tests and requirements to identify any gaps in traceability, ensuring that everything needing a test is covered. I’ll walk you through an example using a hypothetical software-as-a-medical-device product, highlighting how the agent provides recommendations for resolving missing links. Please take a moment to review the findings and consider how this can streamline your workflow!, In this video, I’m excited to show you how our Complaint Agent works to enhance complaint management. It scans and categorizes complaints, flags critical issues, and provides actionable recommendations, significantly reducing documentation time by 90%. I’ll walk you through a hypothetical example involving an insulin delivery system, demonstrating how the agent identifies problems and suggests classifications. Please take a moment to review the findings and consider how this could improve our processes., In this video, I’m excited to show you how our Anomaly Review Agent works to enhance anomaly management. The agent scans records for completeness, flags missing evidence, and suggests updates to ensure critical anomalies are addressed promptly. I’ll walk you through its capabilities, including how it analyzes data from various systems and provides actionable recommendations. Please take a moment to review the agent's findings and consider how it can streamline your workflow. (733 words) - [Physical AI](/content/industries/physical-ai/index.html): Learn how Ketryx accelerates functional safety for physical AI. (729 words) - [Medical Device Software Integration Tool - Ketryx](/content/capabilities/integrations/index.html): Connect your preferred development tools, cloud infrastructure, and languages into a single traceable Software Development Life Cycle (SDLC). (271 words) - [Ketryx’s New Integration with Azure DevOps (ADO): End-to-End Traceability for Regulated Teams](/content/blog/ado-integration/index.html): Learn about Ketryx's integration with Azure DevOps, which streamlines risk management, documentation, and traceability for regulated teams. (1,022 words) - [21 CFR Part 11 Compliance Guide for Jira (Atlassian)](/content/blog/21-cfr-part-11-compliance-guide-for-jira-atlassian/index.html): Jira, Atlassian’s product management software, can be an excellent choice to ensure companies are compliant with 21 CFR Part 11. However, Jira alone is unable to ensure compliance with 21 CFR Part 11. To become compliant with Part 11, Jira needs to be properly managed with specific plugins and/or external software. Although Jira has many important features to help with Part 11, companies using Jira to be FDA 21 CFR Part 11 compliant need to be aware of specific pitfalls within Jira that can push them out of compliance., In this video, I demonstrate how our new system, Ketryx, enhances the quality management process by adding electronic signatures to controlled records in Jira. I show how to edit a resolved item, request approval, and add an electronic signature using biometric authentication. Ketryx ensures that all necessary approvals are obtained and enforces compliance with Part 11 regulations. Additionally, I explain the importance of keeping records and demonstrate how Ketryx maintains a detailed history of changes and provides traceability between linked items. Watch the video to learn how Ketryx streamlines the quality management process and ensures compliance. (877 words) - [About Ketryx | Company Information - Ketryx](/content/about/company/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (1,403 words) - [“Did We Catch Everything?” How Ketryx Turns Risk Management into Proactive Product Intelligence](/content/blog/ai-for-risk-management/index.html): Managing complex risk documentation across hundreds of failure modes is a human cognition problem. See how AI helps teams verify completeness, without replacing engineering judgment. (1,793 words) - [Pharma and Biotech](/content/industries/pharma-and-biotech/index.html): Automate documentation and compliance for life science teams. Real-time traceability, AI-powered change impact assessment, Git-integrated workflows, automatic documentation, and market-ready outputs. (901 words) - [A brief overview of cloud security for standard and safety-critical software](/content/blog/a-brief-overview-of-cloud-security/index.html): Learn three basic steps to fortify your cloud environment (792 words) - [Page Not Found - Ketryx Compliance Framework](/content/blog/medical-device-software-validation-and-verification-for-regulatory-compliance.html) (9 words) - [Watch On Demand Demo - Ketryx Compliance Framework](/content/preview-ketryx/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (623 words) - [Best Practices for Maintaining a Requirement Traceability Matrix in Agile](/content/blog/best-practices-for-maintaining-a-requirement-traceability-matrix-in-agile.html): Tips and techniques for effectively managing and updating the RTM in an Agile environment (1,067 words) - [How Quality Teams Are Using AI Agents to Scale Their Impact](/content/blog/ai-agents-quality-impact/index.html): Quality teams are turning to AI agents to free them up from manual work, so they can focus on critical risks. Here's how. (652 words) - [Page Not Found - Ketryx Compliance Framework](/content/learn/webinars/register/why-building-ai-ml-enabled-medical-devices-requires-ci-cd-a-transition-path.html) (9 words) - [Page Not Found - Ketryx Compliance Framework](/content/learn/webinars/register/fda-cyber-guidance-implications-for-soup-and-ots-risk-management.html) (9 words) - [Page Not Found - Ketryx Compliance Framework](/content/learn/webinars/register/using-a-risk-based-approach-to-comply-with-fda/index.html) (9 words) - [AI San Diego Meetup - Ketryx - Unburdening Builders](/content/ai-san-diego-meetup/index.html): Join us in San Diego during the MedTech Conference as Ketryx brings medtech leaders together for cocktails, appetizers, and real-world conversations about how teams are moving beyond outdated workflows and introducing AI into their products and processes. Hear from experts, connect with peers, and be part of a community working to bring safe, effective AI to life sciences., Connect with life sciences innovators and learn how to validate AI faster so you can bring life-changing technology to patients sooner. (350 words) - [Page Not Found - Ketryx Compliance Framework](/content/learn/webinars/register/transitioning-from-monolithic-to-microservices-how-to-adopt-a-systems-of-systems-approach-for_your_sdlc.html) (9 words) - [Page Not Found - Ketryx Compliance Framework](/content/learn/webinars/register/postmarket-surveillance-of-ai-systems-proactive-methods-for-identifying-risk-and-improving-product-quality.html) (9 words) - [Page Not Found - Ketryx Compliance Framework](/content/learn/webinars/register/jira-for-iec-62304-developing-fda-compliant-software.html) (9 words) - [Medical Device Software Development FDA Process Compliance - Ketryx](/content/function/developer/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (878 words) - [Robotics — AI-Powered IEC 61508 Compliance](/content/industries/robotics/index.html): Automate IEC 61508 compliance for robotics software. Real-time traceability, AI-powered change impact analysis, and TÜV certification-ready documentation. (972 words) - [Medical Software Development Resources | SaMD Resources for Devs & Executives - Ketryx](/content/learn/white-papers/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (469 words) - [Ketryx for Automotive — AI-Powered ISO 26262 Compliance](/content/industries/automotive/index.html): Automate ISO 26262 compliance for automotive software. Real-time traceability, AI-powered change impact analysis, and ASPICE-ready documentation. (667 words) - [Hardware-Software Medical Device Development - Ketryx](/content/use-case/hw-sw-applications/index.html): Unify mechanical, electrical, and software development with AI-native traceability. Accelerate hardware-software integration with FDA and ISO compliance. (886 words) - [AI Agents Launched to Streamline Compliance in Safety-Critical Sectors](/content/blog/ai-agents-launched-to-streamline-compliance-in-safety-critical-sectors.html): Ketryx’s suite of AI agents is designed to help highly regulated industries move products through typically slow development processes (235 words) - [Defense — AI-Powered CMMC Compliance](/content/industries/defense/index.html): Automate CDRL generation and CMMC compliance evidence for defense software programs. Real-time traceability, AI-powered change impact analysis, and authorization-ready documentation. (696 words) - [Ketryx for Aerospace — AI-Powered DO-178C Compliance](/content/industries/aerospace/index.html): Automate DO-178C compliance for avionics software. Real-time traceability, AI-powered change impact analysis, and certification-ready documentation. (707 words) - [AI/ML - Ketryx](/content/function/ai-ml/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (425 words) - [EU AI Act](/content/eu-ai-act/index.html): Learn how Ketryx maps to the key obligations of the EU AI Act (Regulation (EU) 2024/1689). (543 words) - [Pricing - Ketryx Compliance Framework](/content/pricing/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (188 words) - [Ketryx Webinars - Ketryx](/content/learn/webinars/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (371 words) - [AI/ML IVD Diagnostics](/content/use-case/ai-ml-ivd-diagnostics/index.html): Enable your developers to release software frequently and use open-source AI/ML packages with regulatory compliance. (582 words) - [AI startup that streamlines medical device compliance raises $39M](/content/blog/ai-startup-that-streamlines-medical-device-compliance-raises-39m.html): A Boston-based startup trying to make medical device compliance easy, seamless and boring announced a new round of venture capital. (137 words) - [Ketryx for Nuclear Energy — AI-Powered IEC 61513 Compliance](/content/industries/nuclear-energy/index.html): Automate IEC 61513 compliance for nuclear software. Real-time traceability, AI-powered change impact analysis, and safety-case-ready documentation. (779 words) - [The Ketryx FDA Software Compliance Platform - Ketryx](/content/product/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (407 words) - [Ketryx Events - Ketryx](/content/learn/events/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (146 words) - [Medical Device Risk Management Software - Ketryx](/content/capabilities/risk-management/index.html): Hi, I'm Megan, a systems engineer and technical product marketing manager at Ketrix. In this video, I discuss the importance of identifying risk controls in our risk management process, which can often be a manual and time-consuming task. I demonstrate how Ketrix can streamline this process by using an agent to evaluate our environment and suggest potential controls for different risks. I encourage you to review the proposed updates, which will be highlighted with green and red lines, and to apply any agreed-upon changes. Your feedback is crucial in ensuring we effectively mitigate risks., In this video, I discuss the importance of verifying all risk controls in the risk management process to ensure compliance and patient safety. I demonstrate how Ketrick's Assistant can streamline this typically manual and complex task by identifying missing test cases and drafting them based on my design history file and regulatory standards. I emphasize that I remain in control of the process, allowing me to review and modify recommendations before implementation. By leveraging Ketrick's A.I., we can enhance our confidence in regulatory readiness and ensure all risks are adequately addressed. I encourage you to consider how this tool can support your risk management efforts. (868 words) - [FDA, EU MDR, & ISO Medical Device 62304 Compliance Software for Jira - Ketryx](/content/use-case/jira-connector/index.html): Learn how to transform Jira into IEC 62304 compliance. (440 words) - [Medical Device Traceability to Automated Tests Software - Ketryx](/content/use-case/traceability-to-automated-tests/index.html) (340 words) - [AI firm Ketryx raises $39M, adds former Medtronic CEO as investor](/content/blog/ai-firm-ketryx-raises-39m-adds-former-medtronic-ceo-as-investor.html): The company, which helps medtech companies with AI compliance, has raised more than $55 million to date. (84 words) - [Systems Engineering - Ketryx](/content/function/systems-engineering/index.html): Unify requirements, risk, testing, and change management across tools with automated traceability and AI-guided compliance for systems engineers. (422 words) - [Medical Device Electronic Quality Management System (eQMS) - Ketryx](/content/capabilities/eqms/index.html): Learn how to turn your medical device software development into FDA compliant traceability. (1,227 words) - [As FDA moves builds out ‘Elsa,’ this AI compliance CEO underscores that need for a hybrid AI approach](/content/blog/as-fda-moves-builds-out-elsa-this-ai-compliance-ceo-underscores-that-need-for-a-hybrid-ai-approach.html): The FDA hails the recent rollout of its internal AI tool, Elsa, as a major move to tackle the crushing weight of regulatory review where documents thousands of pages long are commonplace. But as reports of a rushed, buggy rollout surface, one regulated AI expert Erez Kaminski, a former AI strategist for Amgen and now CEO of Ketryx, says the agency may be in for an uphill battle — at least initially as it builds out the infrastructure. “I think it’s just really, really hard to make regulated AI work well,” Kaminski said. (142 words) - [Change Impact Assessment - Ketryx](/content/capabilities/change-impact-assessment/index.html): Apply AI to identify, analyze, and act on change impacts across the DHF with less manual work and greater confidence. (464 words) - [Software as a Medical Device (SaMD) Lifecycle Management & FDA Compliance Software - Ketryx](/content/use-case/samd/index.html): Build and maintain FDA-regulated software as a medical device in minutes. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11. (452 words) - [Multifunction Device](/content/use-case/multifunction-device/index.html): Enable your developers to release device and non-device functions separately for your multifunction device. (449 words) - [🟩 GenAI in Your TPLC](/content/use-case/gen-ai-in-your-tplc/index.html): Learn how to turn your medical device software development into FDA compliant traceability. (246 words) - [Medical Device Quality Management System (QMS) Software - Ketryx](/content/capabilities/enforcement/index.html): Learn how to enforce your Medical Device QMS across preferred DevTools (369 words) - [AI/ML Medical Device Compliance Software - Ketryx](/content/use-case/ai-ml-med-device/index.html): Enable your developers to release software frequently and use open-source AI/ML packages with regulatory compliance. (740 words) - [Medical Device Requirements Management Software - Ketryx](/content/capabilities/requirements-management/index.html) (508 words) - [Medical Device Software Bill of Materials (SBOM) Management Software | SBOM Tool Software - Ketryx](/content/capabilities/sbom-software-bill-of-materials/index.html): Learn how to manage cybersecurity risk with software bill of materials (SBOM) management for medical devices. (656 words) - [Medical Device Software Development Life Cycle (SDLC) Documentation - Ketryx](/content/capabilities/documentation/index.html): Learn how to produce audit-ready and submission-ready documentation through the systems your developers are already using. (452 words) - [Medical Device Quality Assurance & Regulatory Affairs (QA/RA) Software - Ketryx](/content/function/quality/index.html): Learn how to enforce your QMS procedures with medical device quality assurance and regulatory compliance software. (670 words) - [Ketryx In the News - Ketryx](/content/about/newsroom/index.html): Get to know the latest stories from and about Ketryx. (331 words) - [Schedule a Demo](/content/schedule-demo-j-j/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11, Route your prospects through Chili Piper (57 words) - [Validated AI Benchmarking Study](/content/validated-ai-benchmarking-study/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11, Route your prospects through Chili Piper (77 words) - [Medical Device Component Reuse Software - Ketryx](/content/use-case/component-reuse/index.html): Enable your developers to release software frequently and use open-source AI/ML packages with regulatory compliance. (443 words) - [Medical Device Traceability Software - Ketryx](/content/capabilities/traceability/index.html): Learn how to turn your medical device software development into FDA compliant traceability. (337 words) - [MCP Access Request](/content/mcp-access-request/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11, Route your prospects through Chili Piper (86 words) - [Ketryx Open Positions - Ketryx](/content/about/open-positions/index.html): Build the future of Safety-Critical Software with us. We are looking for the various roles to extend our team. (119 words) - [Why Ketryx - Ketryx Compliance Framework](/content/about/why-ketryx/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (380 words) - [Schedule a Demo - Ketryx Compliance Framework](/content/schedule-demo/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11, Route your prospects through Chili Piper (43 words) - [Imprint](/content/imprint/index.html) (25 words) - [On-Demand Demo - Ketryx Compliance Framework](/content/on-demand-demo/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11, Route your prospects through Chili Piper (629 words) - [Ketryx AI Agents: How People and Agents Build Regulated Products Together](/content/blog/ketryx-ai-agents/index.html): Introducing Ketryx Agents—AI-powered coworkers designed to automate the most tedious and error-prone parts of regulated development, while increasing quality and safety. (1,914 words) - [blog/understanding-software-as-a-medical-device-samd/index.html](/content/blog/understanding-software-as-a-medical-device-samd/index.html) (3,111 words) - [We Put Our Own QMS Under the Microscope. Here’s What We Found.](/content/blog/we-put-our-own-qms-under-the-microscope-heres-what-we-found.html): Learn how Ketryx did a QMS reevaluation to remove any bloat from our process to ensure we can work in an agile way while preserving quality. (995 words) - [From Vision to Validation: The Story Behind Ketryx's Journey to Transforming MedTech Software](/content/blog/story-of-ketryx/index.html): Discover the inspiring founding story of Ketryx, a pioneering technology company dedicated to driving software innovation across the medical field. (1,452 words) - [Navigating ISO 26262 and IEC 61508-3 Functional Safety Standards for Safety-Critical Software](/content/blog/navigating-iso-26262-and-iec-61508-3-functional-safety-standards.html): Learn how ISO 26262 and IEC 61508-3 govern safety-critical software development, from hazard analysis to traceability requirements. Discover common pitfalls and practical strategies to build compliance into your engineering process from the start. (3,440 words) - [A Comprehensive Guide to IEC 62304: Navigating the Standard for Medical Device Software](/content/blog/a-comprehensive-guide-to-iec-62304-navigating-the-standard-for-medical-device-software.html): Learn how to navigate the IEC 62304 standard for medical device software, from risk management and compliance to achieving certification, ensuring your products meet safety and regulatory standards across the entire software lifecycle. (1,345 words) - [FDA Class II Medical Device Regulations and Compliance](/content/blog/fda-class-ii-medical-device-regulations-and-compliance.html): Learn how to navigate the regulatory requirements for Class II medical devices, including premarket submissions and quality systems, to ensure safety, efficacy, and compliance. (1,990 words) - [Ketryx MCP](/content/capabilities/ketryx-mcp/index.html): Build with FDA compliance and ALM software 3x faster with Ketryx Compliance Framework. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (443 words) - [How to Validate Ketryx](/content/blog/how-to-validate-ketryx/index.html): Learn how Ketryx validates its platform for medical device software companies, and get expert guidance on which validation strategy your organization should pursue. (1,530 words) - [AI Agents - Ketryx](/content/capabilities/ai-agents/index.html): Build with FDA compliance and ALM software 3x faster with Ketryx Compliance Framework. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11, In this video, I walk you through how to build an anomaly scoping agent in the Catrix platform to proactively analyze bugs and their potential impacts on our project. We've heard from many of you that triaging bugs can be quite challenging, especially regarding their influence on requirements and design controls. By creating a custom agent, we can assess anomalies from our development history and understand their effects on various system components. I demonstrate this process using an existing agent that analyzed two anomalies, providing a detailed report on their impacts. I encourage you to explore this feature to help your teams make more informed decisions before our next release., Use Loom to record quick videos of your screen and cam. Explain anything clearly and easily – and skip the meeting. An essential tool for hybrid workplaces., Use Loom to record quick videos of your screen and cam. Explain anything clearly and easily – and skip the meeting. An essential tool for hybrid workplaces., Hi there! In this video, I’m excited to show you how our Kettrix AI Requirement Conflict Agent works. We’ll explore how it identifies and resolves conflicting requirements, using a hypothetical insulin delivery system as an example. I’ll walk you through the agent's workflow, including its recommendations for resolving conflicts. Please take a moment to review the findings and consider how this can streamline your processes., Use Loom to record quick videos of your screen and cam. Explain anything clearly and easily – and skip the meeting. An essential tool for hybrid workplaces., Hi there! In this video, I’m excited to show you how our Ketrix AI agent, specifically the Change Request Review agent, works to enhance the change request process. We’ll explore how it identifies incomplete requests and provides recommendations, which can save you significant time and effort. I encourage you to consider how this tool can help streamline your workflow and reduce documentation time by up to 90%. Let’s dive in!, Hi there! In this video, I’m excited to show you how our Kettrix AI Test Coverage agent works. It scans your tests and requirements to identify any gaps in traceability, ensuring that everything needing a test is covered. I’ll walk you through an example using a hypothetical software-as-a-medical-device product, highlighting how the agent provides recommendations for resolving missing links. Please take a moment to review the findings and consider how this can streamline your workflow!, In this video, I’m excited to show you how our Complaint Agent works to enhance complaint management. It scans and categorizes complaints, flags critical issues, and provides actionable recommendations, significantly reducing documentation time by 90%. I’ll walk you through a hypothetical example involving an insulin delivery system, demonstrating how the agent identifies problems and suggests classifications. Please take a moment to review the findings and consider how this could improve our processes., In this video, I’m excited to show you how our Anomaly Review Agent works to enhance anomaly management. The agent scans records for completeness, flags missing evidence, and suggests updates to ensure critical anomalies are addressed promptly. I’ll walk you through its capabilities, including how it analyzes data from various systems and provides actionable recommendations. Please take a moment to review the agent's findings and consider how it can streamline your workflow. (646 words) - [The latest (June 2023) changes to the FDA’s new premarket submission guidance](/content/blog/the-latest-june-2023-changes-to-the-fdas-new-premarket-submission-guidance.html): This guidance on "Content of Premarket Submissions for Device Software Functions" outlines key changes software developers, regulatory affairs, and quality professionals need to know about the differences between the original 2005 guidance and the 2023 version., Explore the "Shared" view on Airtable. (816 words) - [Privacy Policy](/content/privacy/index.html) (958 words) - [FDA Class I Medical Device Regulations and Compliance](/content/blog/fda-class-i-medical-device-regulations-and-compliance.html): Learn how to navigate the regulatory requirements for Class I medical devices, including labeling, 21 CFR Part 820 compliance, and post-market surveillance, simplified for successful market entry. (1,763 words) - [Medtech compliance — not regulation — is stifling innovation](/content/blog/medtech-compliance-not-regulation-is-stifling-innovation.html): Regulation is stifling innovation seems to be a prevailing opinion among medtech leaders who believe the Food and Drug Administration’s rules are slowing medical device advancements — especially when it comes to software. (1,531 words) - [Validated AI Conference - Ketryx](/content/gen/validated-ai-conference/index.html): Validated AI Conference brings together regulated product leaders in Cambridge and online for candid conversations on building and scaling AI in compliant environments. Hear from experts, connect with peers, and explore practical approaches to validating AI without sacrificing speed or regulatory rigor., Connect with life sciences innovators and learn how to validate AI faster so you can bring life-changing technology to market sooner. (1,076 words) - [Ketryx 2.9](/content/blog/ketryx-2-9/index.html): The release of this new version makes our connected lifecycle management system even more powerful for medical device software teams. (778 words) - [Deephealth - Ketryx](/content/case-studies/deephealth-case-study/index.html) (648 words) - [Ketryx Assistant](/content/capabilities/ketryx-assistant/index.html): Build with FDA compliance and ALM software 3x faster with Ketryx Compliance Framework. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (523 words) - [Ketryx Marks Milestone Year, Impacting Over 20M+ Patients in MedTech - Ketryx Compliance Framework](/content/press-release/ketryx-marks-milestone-year-impacting-over-20m-patients-in-medtech.html): Ketryx, the leader in connected lifecycle management for safety-critical industries, today announced key accomplishments for 2024, marking a pivotal year of growth and innovation. (717 words) - [Tracing Manual and Automated Tests across Jira and Connected Systems - Ketryx](/content/videos/tracing-manual-and-automated-tests-across-jira-and-connected-systems.html) (13 words) - [Case Studies - Ketryx](/content/learn/case-studies/index.html) (61 words) - [Jira - Ketryx Integrations](/content/integrations/jira/index.html) (362 words) - [Meta - Ketryx](/content/case-studies/how-meta-reality-labs-accelerates-safe-innovation-with-ai.html) (437 words) - [Ketryx raises $14M in Series A funding led by Lightspeed Venture Partners - Ketryx Compliance Framework](/content/press-release/ketryx-raises-14m-in-series-a-funding-led-by-lightspeed-venture-partners.html): Investment fuels innovation to ensure patient safety and validate the use of AI in medical devices (684 words) - [Ketryx Announces Beta of Model Context Protocol (MCP) to Bring Compliance Intelligence into AI Workflows - Ketryx Compliance Framework](/content/press-release/ketryx-announces-mcp/index.html): Launch enables regulated development teams to use agents with full compliance awareness from AI tools like ChatGPT, Claude, and Copilot (590 words) - [Validated AI Conference Half Day](/content/events/validated-ai-conference-half-day-april-2026/index.html) (546 words) - [ADO to Polarion Traceability - Ketryx](/content/videos/ado-polarion-traceability/index.html) (56 words) - [Jira Data Center - Ketryx Integrations](/content/integrations/jira-data-center/index.html) (358 words) - [Announcing Ketryx’s UL Certification to IEC 62304, ISO 13485, and ISO 14971](/content/blog/announcing-ketryxs-ul-certification/index.html): Ketryx announces our UL certification for IEC 62304, ISO 14971, and ISO 13485, which helps medical device companies build validated software in an FDA-compliant way. (771 words) - [Ketryx 2.0 Release](/content/blog/ketryx-2-0-release/index.html): Ketryx 2.0 tackles FDA Cybersecurity guidance requirements, including SBOM management, risk management, and superior traceability. (1,314 words) - [Medical Devices — AI-powered lifecycle management for life science teams](/content/industries/medical-devices/index.html): Automate documentation and compliance for life science teams. Real-time traceability, AI-powered change impact assessment, Git-integrated workflows, automatic documentation, and market-ready outputs. (910 words) - [Recalls Are Rising. Panic Doesn’t Have To.](/content/blog/recalls-are-rising-panic-doesnt-have-to/index.html): FDA recalls are an ongoing operational reality, and the real damage isn't the recall itself—it's how unprepared organizations are to execute quickly, risking patient safety, reputation, and regulatory standing. (793 words) - [Introducing Ketryx Intelligence: Accelerate Product Development Safely with Generative AI](/content/blog/ketryx-intelligence/index.html): Explore new AI-powered features, such as intelligent QMS querying, smart filtering, and automated test case generation, that simplify complex processes and increase efficiency in regulated environments. (1,001 words) - [New FDA SOUP/OTS Guidance: Managing Risk and Testing at Scale - Ketryx Compliance Framework](/content/learn/webinars/on-demand/new-fda-soup-ots-guidance-managing-risk-and-testing-at-scale.html) (113 words) - [Optimizing a Regression Testing Agent - Ketryx](/content/videos/optimizing-a-regression-testing-agent/index.html) (8 words) - [Streamlining Validation with Ketryx - Ketryx](/content/videos/streamlining-validation-with-ketryx/index.html) (7 words) - [How Cytovale Transformed Change Impact Assessment with Ketryx AI - Ketryx](/content/case-studies/how-cytovale-transformed-change-impact-assessment-ketryx-ai.html) (708 words) - [Claude Code - Ketryx Integrations](/content/integrations/claude/index.html) (272 words) - [Inside Ketryx’s Customer Validation Package](/content/blog/inside-ketryxs-customer-validation-package/index.html): Ketryx validates the Ketryx Platform under a UL-certified quality management system and ships every major and minor release with a customer‑shareable validation package. Most customers either accept Ketryx’s validation as supplier documentation or add a light layer of internal, use‑case testing. This page summarizes the approach and what you’ll receive. (1,053 words) - [Webinars - How Flo Is Building Regulatory Readiness, Fast - Ketryx Compliance Framework](/content/learn/webinars/register/rerun-how-flo-is-building-regulatory-readiness-fast.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (212 words) - [Scaling AI Responsibly for MedTech and Life Sciences with Validated AI - Ketryx](/content/videos/scaling-ai-responsibly-firesidechat/index.html) (67 words) - [FDA Predetermined Change Control Plan (PCCP) Template - Ketryx](/content/assets/pccp-template/index.html): This template is designed to assist organizations in developing a comprehensive plan to manage and assess modifications to Machine Learning Device Software Functions (ML-DSFs) in medical devices. The Predetermined Change Control Plan (PCCP) is a document that outlines the planned changes to the device, the methods for evaluating these changes, and the impact assessment to ensure the continued safety and effectiveness of the device. (417 words) - [Why Obsessing Over Documentation Might Be Making Your Product Less Safe](/content/blog/document-centric-approach/index.html): Learn how regulated teams can move from a document-centric approach to creating documentation automatically as a byproduct of development work. (851 words) - [Ketryx AI Change Impact Assessment - Ketryx](/content/videos/assistant-change-impact-assessment/index.html) (8 words) - [UL Certification: A Launchpad for Product Development Excellence](/content/blog/ul-certification-a-launchpad-for-product-development-excellence.html): Early in my company’s short history, I almost made a big mistake by passing on getting UL Certification. My team, however, made a compelling case to move forward with what ended up being a core driver of our success to date in attracting new customers and partners. (460 words) - [Ketryx Enters 2026 with Record Momentum as Demand for Validated AI Surges - Ketryx Compliance Framework](/content/press-release/momentum-as-demand-for-validated-ai-surges/index.html): $39M Series B, First Validated AI Agents, and Major Customer Wins Position Ketryx as the Compliance Platform of Choice for Life Sciences (822 words) - [Why The Epidemic In Quality Failures And What MedTechs Can Learn](/content/blog/why-the-epidemic-in-quality-failures-and-what-medtechs-can-learn.html): Explore how outdated systems, manual processes, and increasing complexity contribute to rising quality failures in safety-critical industries. Learn how automation and AI can revolutionize quality management, ensuring safety, efficiency, and innovation. (373 words) - [Understanding the FDA's 2026 Clinical Decision Support Software Guidance: What Medical Device Companies NTK](/content/blog/understanding-the-fdas-2026-clinical-decision-support-software-guidance-what-medical-device-companies-need-to-know.html): Learn how the FDA's 2026 CDS guidance changes clinical decision support software classification, enforcement discretion, and transparency requirements for medical device companies. (1,576 words) - [FDA Traceability Matrix Requirements for Medical Devices](/content/blog/traceability-101/index.html): Traceability refers to the ability to track the lineage of information, requirements, and design elements throughout the software development lifecycle and often involves keeping records of the relationships between various artifacts, such as user stories, requirements, design documents, code, test cases, and more. (1,849 words) - [Copilot - Ketryx Integrations](/content/integrations/copilot/index.html) (207 words) - [Webinars - Streamlining Multi-Region Submissions: MDR, FDA, and EU AI Act - Ketryx Compliance Framework](/content/learn/webinars/register/streamlining-multi-region-submissions-with-raps/index.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (304 words) - [Beacon Biosignals - Ketryx](/content/case-studies/beacon-biosignals/index.html) (591 words) - [End-to-End Coding Agents - Ketryx](/content/videos/end-to-end-coding-agents/index.html) (58 words) - [Medtronic/Nutrino - Ketryx](/content/case-studies/nutrino-case-study/index.html) (454 words) - [Anomaly Scoping Agents - Ketryx](/content/videos/anomaly-scoping-agents/index.html) (55 words) - [AI/ML GxP Pharma](/content/use-case/ai-ml-gxp-life-science/index.html): Enable your developers to release software frequently and use open-source AI/ML packages with regulatory compliance. (524 words) - [Using a risk-based approach to comply with 21 CFR Part 11 - Ketryx Compliance Framework](/content/learn/webinars/on-demand/using-a-risk-based-approach-to-comply-with-21-cfr-part-11.html) (60 words) - [Ketryx 2.8](/content/blog/ketryx-2-8/index.html): Ketryx 2.8 is focused on enabling component reuse, system of systems, and microservice architecture. These new features enable medical device software teams to develop safer software faster. (937 words) - [Boston RAPS Chapter In Person Event: Navigating Evolving Global Requirements to Strengthen Regulatory Readiness Worldwide](/content/events/boston-raps-networking/index.html) (192 words) - [Webinars - Navigating the FDA’s Total Product Lifecycle Framework for Generative AI Devices - Ketryx Compliance Framework](/content/learn/webinars/register/navigating-the-fdas-total-product-lifecycle-framework-for-generative-ai-devices-2.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (137 words) - [Vektor Medical - Ketryx](/content/case-studies/vektor-medical-case-study/index.html) (471 words) - [Ketryx Intelligence - Ketryx](/content/videos/ketryx-intelligence/index.html) (31 words) - [Why Resubmit When You Can Ship? 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QMSR, IEC 62304, and GPSV govern the final design record, not the order your engineering work happens. (1,245 words) - [Life Sciences AI on Tap: Connect with Boston’s Life Sciences Community](/content/events/life-sciences-ai-march/index.html) (120 words) - [Why So Many Medical Device Companies Lack Real-Time Traceability and Visibility](/content/blog/why-so-many-medical-device-companies-lack-real-time-traceability-and-visibility.html): See why MedTech companies need real-time visibility and traceability through interoperability to reduce risks and accelerate product delivery. (2,174 words) - [Ketryx Announces DeepHealth Selected Its Software to Accelerate AI-Powered Health Informatics Innovation - Ketryx Compliance Framework](/content/press-release/ketryx-announces-deephealth-selected-its-software-to-accelerate-ai-powered-health-informatics-innovation.html) (588 words) - [Webinars - Paving the Way for Continuous Innovation: Navigating FDA PCCP Authorization for AI-Driven Medical Devices - Ketryx Compliance Framework](/content/learn/webinars/register/paving-the-way-for-continuous-innovation-navigating-fda-pccp-authorization-for-ai-driven-medical-devices.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. 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Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (280 words) - [Product Spotlight Webinar: AI-Native Development & Compliance with Ketryx MCP - Ketryx Compliance Framework](/content/learn/webinars/on-demand/product-spotlight-webinar-ai-native-development-compliance-with-ketryx-mcp.html) (156 words) - [Flo Health - Ketryx](/content/case-studies/flo-health/index.html) (721 words) - [Aignostics - Ketryx](/content/case-studies/aignostics-case-study/index.html) (674 words) - [Validated AI Conference](/content/events/validated-ai-conference/index.html) (140 words) - [AWS - Ketryx Integrations](/content/integrations/aws/index.html): Build with FDA compliance and ALM software 3x faster with Ketryx Compliance Framework. 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Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (180 words) - [Ketryx raises $39M to advance AI compliance in life sciences](/content/blog/ketryx-raises-39m-to-advance-ai-compliance-in-life-sciences.html): AI-native compliance infrastructure, trusted by top Life Science and Fortune 500 firms, secures funding led by Transformation Capital. (134 words) - [AI San Diego Meetup - Ketryx](/content/gen/ai-san-diego-meetup/index.html): Join us in San Diego during the MedTech Conference as Ketryx brings medtech leaders together for cocktails, appetizers, and real-world conversations about how teams are moving beyond outdated workflows and introducing AI into their products and processes. Hear from experts, connect with peers, and be part of a community working to bring safe, effective AI to life sciences., Connect with life sciences innovators and learn how to validate AI faster so you can bring life-changing technology to patients sooner. (350 words) - [Regulatory Pathways - Ketryx](/content/assets/regulatory-pathways/index.html): Learn about the different approval pathways possible, and how to find the one that works best for you. (43 words) - [AI Privacy and Confidentiality](/content/ai-privacy-and-confidentiality/index.html) (565 words) - [Webinars - From AI Curious to AI Native: Top Use Cases For AI Across Regulated SDLCs - Ketryx Compliance Framework](/content/learn/webinars/register/ai-curious-to-ai-native-may-2026/index.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. 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Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (306 words) - [Q&A: The facts about the PATCH Act](/content/blog/q-a-the-facts-about-the-patch-act/index.html): As the compliance deadline edges closer for the Protecting and Transforming Cyber Health Care Act, what do cyber device providers in the US need to do to meet the requirements and ensure a smooth transition? (207 words) - [Building an Audit-Ready Secure SDLC - Ketryx Compliance Framework](/content/learn/webinars/on-demand/building-an-audit-ready-secure-sdlc/index.html) (132 words) - [Validated AI Conference - On Demand - Ketryx](/content/gen/validated-ai-conference-on-demand/index.html): , Connect with life sciences innovators and learn how to validate AI faster so you can bring life-changing technology to market sooner. (255 words) - [Webinars - Transitioning to FDA’s New Premarket Submission Guidance: Impact on Quality Systems and Development Practices - Ketryx Compliance Framework](/content/learn/webinars/register/transitioning-to-fdas-new-premarket-submission-guidance.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (259 words) - [The Compliance Confidence Trap: What 100 Requirements Reviews Still Miss](/content/blog/the-compliance-confidence-trap-what-100-requirements-reviews-still-miss.html): A rigorous review process can create false certainty. 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(147 words) - [ADO for IEC 62304 and AI: Developing FDA-Compliant Software in Azure DevOps - Ketryx Compliance Framework](/content/learn/webinars/on-demand/ado-for-iec-62304-and-ai-developing-fda-compliant-software-in-azure-devops.html) (119 words) - [Heartflow - Ketryx](/content/case-studies/heartflow-case-study/index.html) (699 words) - [Constructive Constraints: Enforcement Is the Key to Faster Medical Software Development](/content/blog/constructive-constraints-enforcement-faster-medical-software-development.html): Manual work required for quality and compliance often slows down MedTech developers. Here’s how you can use automated enforcement to remove common barriers. 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(596 words) - [Webinars - Product Spotlight Webinar: AI-Native Development & Compliance with Ketryx MCP - Ketryx Compliance Framework](/content/learn/webinars/register/mcp-2026/index.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (182 words) - [SaMD Regulatory Requirements White Paper - Ketryx Compliance Framework](/content/white-papers/samd-regulatory-requirements/index.html): Learn which regulations and standards are necessary to meet compliance for Software as a Medical Device. 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This eBook, written by former FDA Paul Jones, addresses the basic structure, training, and background of FDA personnel, the most common mistakes he sees companies make while building and maintaining software, and what to expect during an audit, as well as good standard practices for avoiding fines and warning letters. (28 words) - [Implementing a PCCP & CI/CD for AI/ML-Enabled Medical Devices - Ketryx Compliance Framework](/content/learn/webinars/on-demand/implementing-a-pccp-ci-cd-for-ai-ml-enabled-medical-devices.html) (268 words) - [Webinars - Why Resubmit When You Can Ship? How to Accelerate Innovation with PCCPs and CI/CD - Ketryx Compliance Framework](/content/learn/webinars/register/why-resubmit-when-you-can-ship-how-to-accelerate-innovation-with-pccps-and-ci-cd.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (305 words) - [American Medical Device Summit](/content/events/american-medical-device-summit-2026/index.html) (23 words) - [How to Make Jira Work for IEC 62304 Development - Ketryx Compliance Framework](/content/learn/webinars/on-demand/how-to-make-jira-work-for-iec-62304-development/index.html) (77 words) - [New in 2.11: RTM Configurations - Ketryx](/content/videos/predefined-rtm-configurations/index.html): Improve traceability with Ketryx's predefined requirements traceability matrix configurations. 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Now, the increasing pressure on early development and the application process is sending many companies scrambling to confirm the documentation for their cybersecurity and reevaluate their developer practices and SOPs., Hi, I'm Erez, the founder and CEO of Ketryx. In this video, I'll show you how to create an FDA compliant SBOM in under 30 seconds. I'll guide you through the process of creating a project, adding a repository URL, and retrieving dependencies. You'll learn how to manage risk and ensure device safety. Finally, I'll demonstrate how to generate a fully fleshed-out project with all the necessary information. No action is required from you, just sit back and learn! (1,744 words) - [Oui Therapeutics - Ketryx](/content/case-studies/oui-therapeutics/index.html) (319 words) - [JavaScript Static Analysis Tools for Medical Devices - Ketryx](/content/assets/javascript-static-analysis-tools-for-medical-devices.html): The focus of this paper is on software applications (Apps) written in Javascript that meet the Food and Drug Administration’s (FDA) regulatory definition of a medical device. Because medical devices are used to treat, diagnose, deliver therapy, etc. their use may result in patient harm, ranging from minor injuries to death. Therefore, freedom from unacceptable risk (safety) is an imperative, and security is a subset of safety. (20 words) - [IDC Spotlight: Connected Life-Cycle Management Streamlines Software Development for Medical Devices White Paper - Ketryx Compliance Framework](/content/white-papers/idc-clm-spotlight-paper/index.html): This Spotlight Paper from leading technology analyst IDC explores how Connected Lifecycle Management (CLM) is transforming software development for regulated industries. (164 words) - [Why the FDA’s Most Common Warning Letter Might Surprise You](/content/blog/why-the-fdas-most-common-warning-letter-might-surprise-you.html): Learn where most companies are falling short during FDA audits. (786 words) - [39 Millionen Dollar Investment für österreichisch-amerikanisches KI-Start-up](/content/blog/39-millionen-dollar-investment-fur-osterreichisch-amerikanisches-ki-start-up.html): Das Start-up Ketryx bietet KI-gestützte Software für Medizinunternehmen. 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Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (172 words) - [Enterprise IVD Company - Ketryx](/content/case-studies/enterprise-ivd-company/index.html) (481 words) - [How Connected Lifecycle Management Is Revolutionizing MedTech Software Development](/content/blog/how-connected-lifecycle-management-is-revolutionizing-medtech-software-development.html): Connected Lifecycle Management platforms have emerged as the best way to innovate safer software faster. 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(197 words) - [Webinars - The Future of Change Management for Cloud-based AI/ML Medical Software - Ketryx Compliance Framework](/content/learn/webinars/register/the-future-of-change-management-for-cloud-based-ai-ml-medical-software.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (236 words) - [Modernizing FDA-Grade Software Development with Validated DevOps - Ketryx](/content/assets/validated-devops-white-paper/index.html): Delivering compliant software quickly without compromising on quality is a significant challenge. 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With traceability as a main component of this standard, the challenge companies often face is how to use preferred development tools like Jira for SDLC management that are not built to provide the level of traceability required by 62304 and the FDA. This guide will focus on how companies can meet IEC 62304 and generate a compliant Requirements Traceability Matrix (RTM) while using Jira. (1,285 words) - [SBOM & Beyond - Ketryx Compliance Framework](/content/learn/webinars/on-demand/sbom-beyond/index.html) (85 words) - [QMS Optimization Workshop Template White Paper - Ketryx Compliance Framework](/content/white-papers/qms-optimization-workshop-template/index.html): This practical workshop template is designed to guide regulated teams in regular QMS reviews to identify process debt and apply a modern, risk-based, AI-assisted approach to quality processes. (308 words) - [Webinars - Simplifying 62304 and AI Compliance with Jira & Polarion - Ketryx Compliance Framework](/content/learn/webinars/register/simplifying-62304-and-ai-compliance-with-jira-polarion.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. 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(170 words) - [Clinical Trial Computerized Systems Regulation Review](/content/blog/clinical-trial-computerized-systems-regulation-review.html): An overview of the latest FDA and EMA requirements regarding Computerized System Guidances, including a comparison of Good Manufacturing Practices (GMP) and Clinical Trial Data Management and a summary of the standards impact on Vendors to Clinical Trial Sponsors (1,471 words) - [From Spreadsheets to System-Level Clarity: How Medical Device Manufacturers Are Transforming Cybersecurity Threat Modeling](/content/blog/from-spreadsheets-to-system-level-clarity-how-medical-device-manufacturers-are-transforming-cybersecurity-threat-modeling.html): Fragmented threat modeling can't keep pace with FDA, CRA, and AI Act requirements. See how connected traceability transforms medical device cybersecurity. (1,372 words) - [MedTech Trends for 2024: Takeaways from JP Morgan's Health Conference](/content/blog/medtech-trends-for-2024-takeaways-from-jp-morgans-health-conference.html): Among the number of groundbreaking announcements and sessions, a prominent theme at the conference was the huge momentum of digitization efforts across healthcare. (875 words) - [Webinars - 62304-Compliant Traceability for Automated Testing - Ketryx Compliance Framework](/content/learn/webinars/register/62304-compliant-traceability-for-automated-testing/index.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (204 words) - [FDA Cyber Guidance and the Software Supply Chain - A Playbook for Shifting Left - Ketryx](/content/assets/fda-cyber-guidance-and-the-software-supply-chain-a-playbook-for-shifting-left.html): Learn how to navigate the complex landscape of cybersecurity for medical devices with this comprehensive guide. This white paper outlines actionable strategies to address vulnerabilities, manage risks, and meet FDA cybersecurity requirements throughout the product lifecycle. Learn how to shift left with integrated tools and processes, enabling faster responses to emerging threats while ensuring compliance and protecting patient safety. (56 words) - [How Regulated Teams Release Every Two Weeks](/content/blog/how-regulated-teams-release-every-two-weeks/index.html): Learn how teams in regulated industries release products every two weeks while staying compliant. (1,634 words) - [Discover Why Traceability Doesn't Have to Be So Hard - Ketryx](/content/assets/discover-why-traceability-doesnt-have-to-be-so-hard.html): Software is the leading cause of medical device recalls. Heavily regulated products such as safety-critical medical devices require that every step of the development process must be traceable with a rigorous process designed to identify potential risk factors and their contributing conditions. (64 words) - [Webinars - Jira for IEC 61508: Functional Safety Where Robotics & Physical AI Teams Already Work - Ketryx Compliance Framework](/content/learn/webinars/register/jira-for-iec-61508-march-2026/index.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (261 words) - [Webinars - Validating AI & LLMs in GxP Use Cases - Ketryx Compliance Framework](/content/learn/webinars/register/validating-ai-llms-in-gxp-use-cases/index.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (165 words) - [A Guide To Implementing CI/CD in Your AI/ML SaMD Projects - Ketryx](/content/assets/ci-cd-ai-ml-white-paper/index.html): The number of AI-powered medical devices is rapidly increasing, with 950 AI/ML-enabled devices already authorized by the FDA. However, the journey to successfully developing and managing these complex systems remains challenging for many manufacturers. Continuous Integration/Continuous Deployment (CI/CD) is now essential for enabling AI/ML in medical software. Medical software teams can align this practice with FDA guidance to ensure product safety while accelerating development timelines. (74 words) - [Webinars - How Flo Is Building Regulatory Readiness for Its AI-Enabled Digital Health App, Fast - Ketryx Compliance Framework](/content/learn/webinars/register/how-flo-is-building-regulatory-readiness-for-its-ai-enabled-digital-health-app-fast.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (201 words) - [SOUP Software Definition and a Guide to Software Regulations of Unknown Provenance](/content/blog/what-is-soup/index.html): SOUP, or Software of Unknown Provenance, is any piece of software used in a medical device that wasn’t developed for use in a medical device (i.e. under 62304) or for which such documentation doesn’t exist. (812 words) - [Postmarket Surveillance of AI Systems: Proactive methods for identifying risk and improving product quality - Ketryx Compliance Framework](/content/learn/webinars/on-demand/postmarket-surveillance-of-ai-systems-proactive-methods-for-identifying-risk-and-improving-product-quality.html) (180 words) - [Introduction to Ketryx - Ketryx](/content/videos/ketryx-demo-video/index.html) (110 words) - [Prosthetics & Robtoics](/content/events/prosthetics-robtoics/index.html) (21 words) - [How to Use Agentic AI to Systematically Prevent Deviations - Ketryx Compliance Framework](/content/learn/webinars/on-demand/how-to-use-agentic-ai-to-systematically-prevent-deviations.html) (90 words) - [Webinars - SBOM and Beyond: FDA-Compliant Cybersecurity Vulnerability Management - Ketryx Compliance Framework](/content/learn/webinars/register/sbom-and-beyond-fda-compliant-cybersecurity-vulnerability-management-2.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (201 words) - [Device Talks Boston | Robotics Summit](/content/events/device-talks-boston-robotics-summit/index.html) (24 words) - [Why building AI/ML-enabled Medical Devices requires CI/CD: A transition path - Ketryx Compliance Framework](/content/learn/webinars/on-demand/why-building-ai-ml-enabled-medical-devices-requires-ci-cd-a-transition-path.html) (38 words) - [European Medical Device Summit](/content/events/european-medical-device-summit/index.html) (22 words) - [Validating AI & LLMs in GxP Use Cases for Pharma - Ketryx Compliance Framework](/content/learn/webinars/on-demand/validating-ai-llms-in-gxp-use-cases-for-pharma/index.html) (147 words) - [Webinars - Navigating the FDA’s Total Product Lifecycle Framework for Generative AI Devices - Ketryx Compliance Framework](/content/learn/webinars/register/navigating-the-fdas-total-product-lifecycle-framework-for-generative-ai-devices.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (140 words) - [Ketryx Raises $39M Series B Round to Power the Future of Regulated Artificial Intelligence for Life Sciences - Ketryx Compliance Framework](/content/press-release/series-b/index.html): Transformation Capital leads round to scale AI-native compliance infrastructure trusted by top Life Science and Fortune 500 companies (662 words) - [New in 2.11: Enhanced Jira Traceability Widget - Ketryx](/content/videos/jira-traceability-widget-improvements/index.html): See how the enhanced Ketryx traceability widget in Jira improves the interoperability of your regulated development ecosystem. (130 words) - [Webinars - Transitioning from Monolithic to Microservices: How to Adopt a Systems of Systems Approach for Your SDLC - Ketryx Compliance Framework](/content/learn/webinars/register/transitioning-from-monolithic-to-microservices-how-to-adopt-a-systems-of-systems-approach-for-your-sdlc.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (236 words) - [Webinars - How Meta Achieves Best-in-Class Engineering in Regulated Environments - Ketryx Compliance Framework](/content/learn/webinars/register/how-meta-preserves-a-best-in-class-engineering-culture-in-a-regulated-environment-may-2026.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (175 words) - [Health ISAC Spring Americas Summit](/content/events/health-isac-spring-americas-summit/index.html) (23 words) - [Navigating Non-Product Software Validation in GxP Environments](/content/blog/navigating-non-product-software-validation-in-gxp-environments.html): Navigating Non-Product Software Validation in GxP Environments (749 words) - [MEDevice Boston](/content/events/medevice-boston/index.html) (21 words) - [IEC 62304 Compliance Checklist - Ketryx](/content/assets/iec-62304-compliance-checklist/index.html): Companies can take a few key steps to evaluate quality practices on their FDA compliance journey to build medical software. Use this checklist to manage the key steps. (12 words) - [Understanding the FDA's New Draft Guidance on AI-Enabled Devices - Ketryx Compliance Framework](/content/learn/webinars/on-demand/understanding-the-fdas-new-draft-guidance-on-ai-enabled-devices.html) (130 words) - [Watch a Demo of Ketryx - Ketryx Compliance Framework](/content/learn/webinars/on-demand/watch-a-demo-of-ketryx/index.html) (56 words) - [Webinars - FDA-Grade AI: Total Product Lifecycle Control with a PCCP - Ketryx Compliance Framework](/content/learn/webinars/register/fda-grade-ai-total-product-lifecycle-control-with-a-pccp.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (158 words) - [SPDX - Ketryx Integrations](/content/integrations/spdx/index.html) (12 words) - [How Flo Is Building Regulatory Readiness, Fast - Ketryx Compliance Framework](/content/learn/webinars/on-demand/how-flo-is-building-regulatory-readiness-fast/index.html) (155 words) - [Connecting SBOM Vulnerabilities to Safety Risk - Ketryx](/content/videos/connecting-sbom-vulnerabilities-to-safety-risk/index.html) (9 words) - [Ketryx 2.7](/content/blog/ketryx-2-7/index.html): Ketryx 2.7 introduces a new set of features that let you keep working in the tools you already use while Ketryx automatically manages traceability across the entire SDLC. With this latest release, software development teams take another step toward validated CI/CD through more connections to systems, better cybersecurity automation, and a deeper integration with Git and other common developer tools. (573 words) - [Webinars - Implementing a PCCP & CI/CD for AI/ML-Enabled Medical Devices - Ketryx Compliance Framework](/content/learn/webinars/register/implementing-a-pccp-ci-cd-for-ai-ml-enabled-medical-devices.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (264 words) - [Validating AI & LLMs in GxP Use Cases - Ketryx Compliance Framework](/content/learn/webinars/on-demand/validating-ai-llms-in-gxp-use-cases/index.html) (90 words) - [How to Use AI Agents in Safety Critical Industries - Ketryx Compliance Framework](/content/learn/webinars/on-demand/how-to-use-ai-agents-in-safety-critical-industries/index.html) (91 words) - [Webinars - ADO for IEC 62304 and AI: Developing FDA-Compliant Software in Azure DevOps - Ketryx Compliance Framework](/content/learn/webinars/register/ado-for-iec-62304-and-ai-developing-fda-compliant-software-in-azure-devops.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (186 words) - [Git for IEC 62304 - Ketryx Compliance Framework](/content/learn/webinars/on-demand/git-for-iec-62304/index.html) (115 words) - [Webinars - How to Use AI Agents in Safety-Critical Industries - Ketryx Compliance Framework](/content/learn/webinars/register/how-to-use-ai-agents-in-safety-critical-industries/index.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (144 words) - [Ketryx is now ISO 27001 certified.](/content/blog/ketryx-is-now-iso-27001-certified/index.html): Notes from inside Ketryx's ISO/IEC 27001:2022 certification: why we pursued it, what surprised us, and what it means for customers in regulated industries. (983 words) - [Key Takeaways from the first Safety-critical Software Meetup in Boston](/content/blog/key-takeaways-from-the-first-safety-critical-software-meetup-in-boston.html): The Boston Safety-critical software and AI/ML Meetup’s first discussion on regulated cloud development and the FDA had three key takeaways: the importance of validation, being prepared for the changing cloud environment, and building a safety-focused software community for better patient outcomes. (804 words) - [Jira for IEC 62304: Developing FDA-Compliant Software - Ketryx Compliance Framework](/content/learn/webinars/on-demand/re-broadcast-jira-for-iec-62304-developing-fda-compliant-software.html) (65 words) - [Ketryx Launches Validated AI Conference, a First-of-Its-Kind Industry Event for AI in Regulated Industries - Ketryx Compliance Framework](/content/press-release/ketryx-launches-validated-ai-conference-a-first-of-its-kind-industry-event-for-ai-in-regulated-industries.html): Event Brings Together Engineering, Quality, and Regulatory Leaders Tackling the AI Compliance Challenge in MedTech and Life Sciences (444 words) - [The Cost of Quality White Paper - Ketryx Compliance Framework](/content/white-papers/the-cost-of-quality/index.html): What is quality and why can it make creating products more expensive? What is the cost of creating high quality products? (131 words) - [Erez Kaminski, Co-Founder & CEO at Ketryx on serving 100M+ customers and scaling regulated products](/content/blog/the-lantern-erez-kaminski-co-founder-ceo-at-ketryx-on-serving-100m-customers-and-scaling-regulated-products.html): Erez Kaminski, Co-Founder & CEO of Ketryx, joins The Lantern to share how a $39M Series B, 4 of the top 5 medical device companies, and 100M patients impacted are reshaping regulated product development. (112 words) - [Why Validated DevOps is the Path Forward for Regulated Software](/content/blog/why-validated-devops-is-the-path-forward-for-regulated-software.html): Discover how Validated DevOps is revolutionizing innovation, ensuring regulatory adherence, and supporting AI/ML integration to deliver safer, faster, and more reliable software in healthcare and beyond. (370 words) - [Ketryx Wants Its Validated AI Agents To Accelerate Compliance Workflows](/content/blog/ketryx-wants-its-validated-ai-agents-to-accelerate-compliance-workflows.html): Company’s Hybrid AI Architecture Combines Foundation Models With Proprietary Regulatory Grounding And Enterprise Data Integration (417 words) - [Ketryx Unveils the First Connected Lifecycle Software for MedTechs - Ketryx Compliance Framework](/content/press-release/ketryx-unveils-the-first-connected-lifecycle-software-for-medtechs.html): Bringing FDA-approved, life-saving innovations to patients 3x faster (427 words) - [Regulatory Pathways White Paper - Ketryx Compliance Framework](/content/white-papers/regulatory-pathways/index.html): Learn about the different approval pathways possible, and how to find the one that works best for you. (99 words) - [Modernizing FDA-Grade Software Development with Validated DevOps White Paper - Ketryx Compliance Framework](/content/white-papers/validated-devops-white-paper/index.html): Discover how Validated DevOps can help you develop software faster while staying compliant. (138 words) - [PATCH Act: How to Comply in 2023 & Beyond](/content/blog/patch-act-how-to-comply-in-2023-beyond/index.html): What is the Patch Act? H.R. 7084, also known as the “PATCH Act of 2022,” outlines a framework for minimal cybersecurity focus within medical devices. The Patch Act (Protecting and Transforming Healthcare Act) has been in development for several years, and a key section grants the FDA long-awaited authority to strengthen its cybersecurity guidance for medical device premarket submissions and post market security management. While the Act and FDA Guidance reflect best practices, the diverse landscape of medical device systems and software ecosystems poses challenges for effective implementation. In particular, the requirement for a Software Bill of Materials, or SBOM, while well-intentioned, isn’t particularly useful to regulators or to users. In fact, the guidance can even make it easier for hackers to exploit known vulnerabilities to compromise patient safety. (2,465 words) - [FDA PCCP Compliance Guide White Paper - Ketryx Compliance Framework](/content/white-papers/fda-pccp-compliance-guide/index.html): Learn more about the FDA's guidance on PCCPs (Predetermined Change Control Plans) for AI/ML-enabled medical device software. (223 words) - [Why Change Impact Assessment Is the Hidden Bottleneck in Medical Device Development](/content/blog/change-impact-assessment-bottleneck/index.html): Traditional Change Impact Assessment slows medical device development and creates compliance risk. Learn how AI-powered CIA reduces cycle times by 70%. (960 words) - [Regulation Isn’t Slowing MedTech. Legacy Thinking Is.](/content/blog/regulation-isnt-slowing-medtech-legacy-thinking-is/index.html): The biggest factor holding MedTech back today isn’t the FDA. It’s the legacy tools, processes, and infrastructure the industry still stubbornly clings to. (807 words) - [Inside the FDA Regulatory Process White Paper - Ketryx Compliance Framework](/content/white-papers/inside-the-fda-regulatory-process/index.html): Former FDA software systems safety expert, Paul Jones, shares his insights. (156 words) - [FDA Cyber Guidance and the Software Supply Chain: A Playbook for Shifting Left White Paper - Ketryx Compliance Framework](/content/white-papers/fda-cyber-guidance-and-the-software-supply-chain-a-playbook-for-shifting-left.html): Discover how to navigate the complex landscape of cybersecurity for medical devices with this comprehensive guide. (162 words) - [Computer Software Assurance](/content/blog/computer-software-assurance/index.html): What FDA's newest draft guidance means for the future of regulated software companies (1,084 words) - [A Guide To Implementing CI/CD in Your AI/ML SaMD Projects White Paper - Ketryx Compliance Framework](/content/white-papers/ci-cd-ai-ml-white-paper/index.html): Learn why CI/CD is crucial for AI/ML SaMD development and how you can transition your organization to CI/CD. (203 words) - [The Spotify layoff letter, a new AI model from Alibaba, and a Boston VC firm abruptly shuts down](/content/blog/the-spotify-layoff-letter-a-new-ai-model-from-alibaba-and-a-boston-vc-firm-abruptly-shuts-down.html): Discover how Ketryx has raised a total of $18 million (209 words) - [IEC 62304 Compliance Checklist White Paper - Ketryx Compliance Framework](/content/white-papers/iec-62304-compliance-checklist/index.html): Companies can take a few key steps to simplify their FDA compliance journey and start building medical software. Use this checklist to go through these key steps. (140 words) - [Three steps for traceability in medical device software development quality and compliance](/content/blog/three-steps-for-traceability-in-medical-device-software-development-quality-and-compliance.html): When reviewing the software in software-as-a-medical-device (SaMD), software-in-medical-devices (SiMD) and systems-of-systems-of-medical-devices (SosMD) at the FDA, I was always looking for sufficient evidence to justify the sponsor’s claim that the device performs as intended — safely and effectively. (264 words) - [Minimizing Risk Through Model-Based Systems Engineering: A Regulatory Perspective](/content/blog/minimizing-risk-through-model-based-engineering/index.html): After two decades at the FDA, one lesson is clear: safer systems are proven before they’re built. Here's why model-based systems engineering matters for medical devices. (794 words) - [Watch how Ketryx applies AI to automate compliance in regulated software](/content/blog/watch-how-ketryx-applies-ai-to-automate-compliance-in-regulated-software.html): In an interview with Ketryx Head of Product Gabriel Pascualy, discover how Ketryx uses AI to embed compliance directly into development workflows, helping regulated industries eliminate manual documentation bottlenecks and accelerate audit readiness. (119 words) - [What Makes a Company Successful at Using AI?](/content/blog/what-makes-a-company-successful-at-using-ai/index.html): Vistra, a major U.S. power producer, had a problem. For its plants to operate efficiently, workers had to continuously monitor hundreds of different indicators, tracking temperatures, pressures, oxygen levels, and pump and fan speeds — and they had to make adjustments in real time. (226 words) - [A Playbook for Transforming Jira to Support IEC 62304 Compliance White Paper - Ketryx Compliance Framework](/content/white-papers/a-playbook-for-transforming-jira-to-support-iec-62304-compliance.html): To bridge the gap between Jira’s capabilities and IEC 62304 requirements, Ketryx offers integration that extends Jira’s functionality to support compliance. Learn how Ketryx transforms Jira into a powerful tool for IEC 62304-compliant software development. (167 words) - [Discover Why Traceability Doesn't Have to Be So Hard White Paper - Ketryx Compliance Framework](/content/white-papers/discover-why-traceability-doesnt-have-to-be-so-hard.html): Explore why traceability has traditionally been so challenging in medical software development and why cloud and AI only add to the complexity. (127 words) - [How to Build Compliant Software Faster with Polarion, Jira, and Ketryx](/content/blog/doing-agile-development-with-jira-and-polarion/index.html): Learn how to simplify IEC 62304 compliance by integrating Jira and Polarion. Discover automated traceability solutions for medical device software teams. (714 words) - [Who pays the bills when AI kills?](/content/blog/who-pays-the-bills-when-ai-kills/index.html): As AI is increasingly becoming more pervasive, it is posing unique challenges in determining who bears the responsibility when AI systems cause harm. (181 words) - [The Future of Healthcare Is Connected & Data-Driven](/content/blog/the-future-of-healthcare-is-connected-data-driven/index.html): Erez Kaminski, CEO & Founder of Ketryx, spoke about the reality of developing cloud-based software in a changing regulatory environment. (186 words) - [Use of AI in imaging paves the way for other medical devices](/content/blog/use-of-ai-in-imaging-paves-the-way-for-other-medical-devices.html): New FDA guidance enables faster release cycles for AI medical devices, allowing continuous improvement and broader adoption while maintaining regulatory oversight, according to Ketryx CEO Erez Kaminski. (145 words) - [Ketryx 2.5](/content/blog/ketryx-2-5/index.html): Ketryx 2.5 marks a significant step forward with the introduction of features that streamline complexity and automate tasks that have historically demanded large amounts of manual work. Your software development life cycle (SDLC) now includes powerful integrations with templates, RTM projects, and Git-based items, all of which enable automated documentation, risk management, and traceability . Manage your vulnerabilities and accelerate your software development faster than ever with our expanded 2.5 features. (542 words) - [How to Stop Managing Documents and Start Managing the Work](/content/blog/how-to-stop-managing-documents-and-start-managing-the-work.html): Learn how to spend less time formatting documents for regulatory compliance and instead, generate artifacts automatically to compile up-to-date evidence. (724 words) - [Spreadsheet Errors: The Hidden Risk In MedTech](/content/blog/spreadsheet-errors-the-hidden-risk-in-medtech/index.html): Learn how Connected Lifecycle Management (CLM) can replace outdated manual processes like using spreadhsheets with automation, improving traceability, efficiency, and patient safety. (301 words) - [Ketryx Careers | Medical Device Compliance Careers](/content/about/careers/index.html): Build the future of Safety-Critical Software with us. We are looking for the various roles to extend our team. (551 words) - [StartUPDATES: New developments from healthcare startups](/content/blog/startupdates-new-developments-from-healthcare-startups.html): Ketryx is a startup that sells a platform — designed around FDA regulations and quality standards (82 words) - [Solving the Systems Interconnectivity Problem](/content/blog/solving-the-systems-interconnectivity-problem-2/index.html): Quality and operations should focus on eliminating friction from their decision-making process by transitioning clerical tasks humans perform to computers. (241 words) - [AI-Assisted Change Impact Assessment: How 9 Engineers Doubled Their Completeness in Half the Time](/content/blog/ai-assisted-change-impact-assessment-how-9-engineers-doubled-their-completeness-in-half-the-time.html): 9 engineers doubled their change impact assessment completeness in half the time using AI. See what we learned from 18 real compliance workflows. (1,424 words) - [The Transformative Impact of Patient Apps in Healthcare](/content/blog/the-transformative-impact-of-patient-apps-in-healthcare.html): How is healthcare adopting Remote Patient Monitoring (RPM) and Remote Therapeutic Patient Monitoring? (182 words) - [StartUp Health Insights: GI Robotics Company Closes $42M](/content/blog/startup-health-insights-gi-robotics-company-closes-42m-week-of-dec-5-2023.html): AI-based startups also did well this week, with several companies using AI in imaging and drug discovery closing rounds. (105 words) - [FDA Cybersecurity Guidance for Medical Devices](/content/blog/fda-cybersecurity-guidance-for-medical-devices/index.html): Discover how the FDA’s cybersecurity guidance helps medical device manufacturers secure their products against cybersecurity threats, ensuring compliance, patient safety, and ongoing device protection throughout the product lifecycle. (839 words) - [From Recalls to Reliability: Tools to Ensure Software Safety in MedTech](/content/blog/from-recalls-to-reliability-tools-to-ensure-software-safety-in-medtech.html): Validation is paramount in ensuring trust in safety-critical devices. It confirms a device’s design follows the approved design plan for medical devices in the US. (367 words) - [Ketryx Raises $39M Series B from Transformation & Lightspeed to Scale AI in MedTech](/content/blog/ketryx-raises-39m-series-b-from-transformation-lightspeed-to-scale-ai-in-medtech.html): Closed in just 14 days, Ketryx has raised a $39M Series B, bringing its total funding to $57M, in a round led by Transformation Capital (Vinay Shah) with participation from Lightspeed Venture Partners (Guru Chahal), MIT’s E14 Fund, Ubiquity Ventures, 53 Stations, and notable angels. Cementing Ketryx as the leader in AI compliance infrastructure layer for MedTech and beyond. (194 words) - [Preparing for the PATCH Act and RTA](/content/blog/preparing-for-the-patch-act-and-rta/index.html): Erez Kaminski, former head of AI with Amgen and founder of Ketryx, and Paul Jones, former FDA official and Executive Vice President of Ketryx, provide an overview of challenges companies face as they work to comply with the new cybersecurity regulations and standards. (192 words) - [Ketryx Tackles Software Safety in Medical Devices Amid Growing Recalls](/content/blog/ketryx-tackles-software-safety-in-medical-devices-amid-growing-recalls.html): Lean about how Ketryx has developed a lifecycle management solution that integrates with the existing tools used by companies, allowing them to accelerate their product delivery and reduce the complexity of their lifecycle. (260 words) - [Ketryx raises $18M to accelerate software development cycles in the medical industry](/content/blog/ketryx-raises-18m-to-accelerate-software-development-cycles-in-the-medical-industry.html): Ketryx raises $18M to transform medical software development with its Connected Lifecycle Management platform, automating quality assurance and ensuring compliance with FDA standards. (238 words) - [Medtech AI developer Ketryx raises $14M in Series A round led by Lightspeed](/content/blog/medtech-ai-developer-ketryx-raises-14m-in-series-a-round-led-by-lightspeed.html): Ketryx raises $14M in Series A funding led by Lightspeed Venture Partners to accelerate innovation in AI-powered medical devices, ensuring patient safety and regulatory compliance through its Connected Lifecycle Management platform. (151 words) - [Medtech Connect Episode 6: The Latest And Greatest In Digital Health Regulations](/content/blog/medtech-connect-episode-6-the-latest-and-greatest-in-digital-health-regulations.html): We will talk about some of the challenges and opportunities that often arise from regulations and Erez will share a personal story about why the safety of medical devices matters so much to him. (111 words) - [Ketryx Rakes In $14M to Speed Up Medical Device Development & Quality Assurance](/content/blog/ketryx-rakes-in-14m-to-speed-up-medical-device-development-quality-assurance.html): Ketryx raised $14 million in Series A funds. The startups sells a platform — designed around FDA regulations and quality standards — that automates much of the work required from medical device companies’ development and quality teams. (185 words) - [How to Survive FDA’s Predetermined Change Control Plan](/content/blog/how-to-survive-fdas-predetermined-change-control-plan.html): This article offers a primer on the PCCP and a strategy for companies to design their products with PCCP in mind, enabling them to leapfrog competitors still bound by traditional regulatory processes. (309 words) - [Mary Brook Delano Named Chief Business Officer at Ketryx](/content/blog/mary-brook-delano-named-chief-business-officer-at-ketryx.html): Ketryx has appointed Mary Brook Delano as chief business officer, a newly created role that is responsible for leading the company’s go-to-market strategy, revenue growth, customer experience, and cross-functional commercial execution. She will report directly to CEO Erez Kaminski. (136 words) - [Innovation Beat: Mass. unveils plan to improve EV charging. Is it moving fast enough?](/content/blog/innovation-beat/index.html): 🧬 Life sciences software company Ketryx in Boston raised $14 million in a deal led by Lightspeed Venture Partners and also including MIT's E14 Fund and Ubiquity Ventures. (161 words) - [Ketryx expands to larger Cambridge office as demand for AI agents grows](/content/blog/ketryx-expands-to-larger-cambridge-office-as-demand-for-ai-agents-grows.html): Ketryx expands to a larger Cambridge office and is hiring across all roles as demand from major medical device companies fuels rapid growth. (209 words) - [Ketryx raises $39M to help medical device makers ship safer products faster](/content/blog/ketryx-raises-39m-to-help-medical-device-makers-ship-safer-products-faster.html): Ketryx Corp., a company transforming product lifecycle development and compliance for medical device makers with artificial intelligence, today announced it has raised $39 million in a Series B funding round led by Transformation Capital. (149 words) - [Ketryx raises $14M in Series A funding led by Lightspeed Venture Partners](/content/blog/ketryx-raises-14m-in-series-a-funding-led-by-lightspeed-venture-partners.html): Ketryx, provider of a connected application lifecycle management software for the life sciences industry, has announced that it has raised $14 Million in Series A funding. (208 words) - [Ketryx Raises $14M in Series A Funding](/content/blog/ketryx-raises-14m-in-series-a-funding-2/index.html): Ketryx secures $14M in Series A funding to advance its Connected Lifecycle Management platform, streamlining regulated software development for the life sciences industry while enhancing quality and compliance. (94 words) - [How Can Medtechs Prepare for the FDA’s Shift Left Strategy on Cybersecurity?](/content/blog/how-can-medtechs-prepare-for-the-fdas-shift-left-strategy-on-cybersecurity.html): Regulators have become increasingly concerned about the potential for medical devices to become a vector for spreading malware attacks across hospital networks, resulting in untold patient harm and billions of dollars globally. (241 words) - [Ketryx: Application Lifecycle Management Company Raises $14 Million](/content/blog/ketryx-application-lifecycle-management-company-raises-14-million.html): Ketryx – a provider of the first and only connected application lifecycle management software for the life sciences industry – recently announced that it has raised $14 Million in Series A funding. (121 words) - [How Flo Health Built FDA-Ready Infrastructure Without Slowing Innovation](/content/blog/how-flo-health-built-fda-ready-infrastructure-without-slowing-innovation.html): The world’s largest women’s health app shares how they achieved regulatory readiness while maintaining 1000+ A/B tests per year. (74 words) - [Former Medtronic CEO joins $39M Ketryx funding round](/content/blog/former-medtronic-ceo-joins-39m-ketryx-funding-round.html): Ketryx today announced a $39 million Series B funding round that included former Medtronic CEO Bill Hawkins as a new investor. (151 words) - [Digital health's top 2023 trends, wrapped](/content/blog/digital-healths-top-2023-trends-wrapped/index.html): Explore Rock Health Advisory's final 2023 insights on digital health trends like AI in healthcare, GLP-1s, and retail health, and discover opportunities for impactful innovation in 2024 (132 words) - [Achieve faster product releases with Ketryx's validated AI agents](/content/blog/achieve-faster-product-releases-with-ketryxs-validated-ai-agents.html): Ketryx announced the launch of the first validated AI agents for regulated industries. This industry-first set of validated agents will transform how highly regulated companies design, develop, and deploy new products to market. 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