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

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.


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



David Simpson Community Champion May 04, 2013

I was just about to suggest that too ;)

Suggest an answer

Log in or Sign up to answer
How to earn badges on the Atlassian Community

How to earn badges on the Atlassian Community

Badges are a great way to show off community activity, whether you’re a newbie or a Champion.

Learn more
Community showcase
Published yesterday in Jira Software

How large do you think Jira Software can grow?

Hi Atlassian Community! My name is Shana, and I’m on the Jira Software team. One of the many reasons this Community exists is to connect you to others on similar product journeys or with comparabl...

135 views 4 5
Read article

Atlassian User Groups

Connect with like-minded Atlassian users at free events near you!

Find a group

Connect with like-minded Atlassian users at free events near you!

Find my local user group

Unfortunately there are no AUG chapters near you at the moment.

Start an AUG

You're one step closer to meeting fellow Atlassian users at your local meet up. Learn more about AUGs

Groups near you