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21 CFR11 Compliance

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?


Shery 215-570-3939

2 answers

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,



1 vote
Ellen Feaheny [AppFusions]
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May 04, 2013

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.

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

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 if you would like to discuss/vet more.



David at David Simpson Apps
Marketplace Partner
Marketplace Partners provide apps and integrations available on the Atlassian Marketplace that extend the power of Atlassian products.
May 04, 2013

I was just about to suggest that too ;)

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