Frequently Asked Questions

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?

In Ketryx, the order of approving Change Requests (CRs) and affected items depends on your organization's chosen process and risk management approach. There are two common practices:

• Traditional Approach: Approve the affected requirements and specifications before approving and working on the Change Request. If changes are needed, the CR and related items are reopened and re-approved.
• Simultaneous Approval Approach: Approve the Change Request, requirements, specifications, code, and tests together, ensuring all related configuration items are consistent and aligned at the time of final review. In this case, records remain open until everything is ready for a coordinated approval.

Ketryx does not mandate a specific order, so the choice depends on your organization's quality assurance standards and risk tolerance. Consistency and traceability between CRs and related items are essential in either approach. See this supporting FAQ for more information. Change request fields include description, impact, reason for change, introduced risks, new items, affected items, and change type. If you would like to add custom fields to this item to reflect your QMS, you can do so via the advanced settings. Typically a Change Request undergoes a series of reviews, however, the exact process will depend on what’s defined in your QMS. Default approval workflows for this item in Ketryx include:

• Owner Review: Checks traceability, SMART criteria, and conformance of design output to design input.
• R&D Lead Review: Verifies executability and technical soundness.
• Quality Manager Review: Ensures documentation quality and regulatory compliance.
• Product Manager Review: Confirms alignment with product goals and requirements.

If any reviewer finds issues, the ticket is reopened for further work.

Here are some quick links to the Work Instructions for Change Request configuration items as well as Manuals for Configuration and Change Management and Maintaining Products.