JIRA and CFR Part 11

Question

Hi All

I have just been asked about FDA CFR Part 11 compliance (IVD - in vitro diagnostics)  with respect to JIRA. After a quick search I found some plugins that add e-signatures but what I would really like to know is, are there any whitepapers or the like, about using JIRA in a way that meets these regualtions? Whats involved etc..

If there are any users out there who are FDA compliant and using JIRA it would be grteat if perhaps you could message me. I am just after afew pointers on whats involved etc.

Many thanks

Nick

Jake {Ketryx} · Answer

Just a note here for anyone coming to this thread ten years later. It's not enough to just install an app from the marketplace to make your Jira instance compliant.  If you are installing add-ons in to your cloud environment you must run a process qualification procedure to validate your configuration.  In the absence of validation documents your Jira set up is not complaint.

I think doing this process yourself is generally a bad idea, for reasons I've outlined in this blog post.

As an alternative, you can purchase a third party tool where the vendor does this validation for you and provides you with the documentation.  One alternative is our product - Ketryx.

Ellen Feaheny [ · Answer

Hi Nick -

I think same Nick that called us yesterday? Not sure..

This was created for FDA Compliance - however, FDA specifications are vast and I think there is alot of interpretations to what "compliance" means.

AppFusions does not purport to be FDA audit cops - only a solution provider to meet an audit requirement. We provide a solution, which you can trial and evaluate - and determine if it meets YOUR interpretation of FDA compliance. These bars/requirement needs may vary, depending on the type of supplier you are.

I will confirm that the plugin was created for exactly FDA compliance purpose, and not by our interpretation of what FDA compliance meant, but by a medical instrument corporation. It is also being used by other corps that evaluated it and felt it met their FDA Compliance audit needs.

It also can be extended, upon request. I expect it also will evolve in time.

Hope this helps.

Ellen

Norman Abramovitz · Answer

I would ask AppFusions since they claim they are CRF Part 11 ready in their advertising.

https://www.appfusions.com/display/PRT11J/Home