21 CFR11 Compliance

Question

Are any of the modules of JIRA compliant with 21CFR 11 (FDA electronic records/electronic signature requriements).  If so, which ones?

Do you have any customers that make software medical devices that are using JIRA (or add-ons)?  If so, which components?

Thanks,

Shery  215-570-3939

Jake {Ketryx} · Answer

Hi Sheryl,

Just a caution here, even if you install plug-ins for Jira, you will still have to produce the validation protocol and execute it yourself to consider it validated.  As an alternative, you could just purchase a product like ours - Ketryx - that creates a validated connection to Jira and automatically configures it.  We provide you with all of the documentation you would need to demonstrate compliance.

We think that self validating Jira is generally a bad idea for product focused organizations because it takes up resources better devoted to product development.  I wrote a blog post about that here.

We created Ketryx to help organizations focus on the work that really matters.  If you'd like to learn more, check us out here.

All the best,

Jake

David at David Simpson Apps · Answer

I was just about to suggest that too ;)

Ellen Feaheny [ · Answer

AppFusions has this plugin addressing this FDA compliance use case for JIRA ... we have a number of customers using this. It's been out for just over a year now.

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

Please also see related threads - search for FDA. Here's a couple:

https://answers.atlassian.com/questions/153167/compliance-market-requirements-standards-for-jira-fields-capture-market-requirement-by-segment

https://answers.atlassian.com/questions/151613/confluence-for-fda-regulated-document-management

There are corps out there (e.g., pharma, medical, food supply, etc.) that are using JIRA/Confluence in this way now - I know.

My email is ellen@appfusions.com if you would like to discuss/vet more.

Best,

Ellen