Frequently Asked Questions

1. How can I use Ketryx for ISO 13485 compliance?

2. How do I integrate Ketryx with Jira?

3. What payload size and timeout limits should we configure on the proxy for Ketryx<->JDC integration flows?

4. How to review Item Records in Ketryx

5. 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?

6. When are Change Requests, CAPAs, Anomalies, and Complaints included in the Change Management File?

7. 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?

8. When during the product lifecycle should change controls be implemented? Are they required for prototypes, version updates, or patch releases?

9. What is the difference between a Software Item Spec and a Task in Ketryx?

10. How do I get the Approvals and Traceability widgets to show in Jira for non-default issue types?

11. How Can I Filter Items by Status and Approval on the All Items Page?

12. Can I produce different documents for different regulatory regions from the same design controls in the same project?

13. Can I defer Anomalies in Ketryx?

14. Can I approve items in bulk?

15. What is the difference between a set of incorporated and referenceable items?

16. Can Ketryx only track parts of a project?

17. Is it possible to manage branched requirements in Ketryx?

18. Does Ketryx take into account and record prior ticket history in Jira?

19. Is the release version in Jira the same as the one in Ketryx?

20. 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?

21. Is it possible to create a Ketryx project before creating a Jira project?

22. What options are available for documentation publication?

23. How is version control ensured for configuration items defined in Jira?

24. What is a configuration item?

25. Why am I unable to access or sign off on a ticket in Jira using the approvals widget?

26. What is the difference between organization permissions and project permissions in Ketryx?

27. How do I delete a configuration item?

28. How do I create and organize my Architecture Diagram in Ketryx? Why would I need it?

29. What are long-lived and point-wise (short-lived) configuration items? What are the differences between the two?

30. For a software item specification, what is the purpose of the "Input" and "Output" field in Jira?