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?

Thanks,

Shery 215-570-3939

1 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

David Simpson Community Champion May 04, 2013

I was just about to suggest that too ;)

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