We are a small company looking for a solution that meets Part 11 security requirements. Has anyone accomplished this? I know a lot of pharmaceutical companies have done this. I am strong user and intermediate administrator but I have not been involved with setting it up (and documenting) in a way to meet these requirements. To start, do we need to purchase the Premium version or will the Standard version suffice? What add-ons are you using? How are you documenting that JIRA is compliant with the regulations.
Hi @Jim Test Account -- I realize this post is a few months old already...is this still something you're exploring? I have a lot of experience configuring Jira for Part-11 compliance, and so I might be able to help you out.
Some quick answers:
You need to consider a lot of stuff when complying with Part 11 in Jira. In most cases, you'll have to combine built-in functionality with some plugins from the Marketplace. Jira offers an audit log for some system changes:
For changes within the issues list made by users (including deleted ones) and export, you can try the Issue History plugin. It's developed by my team.
Additionally, you'll need the e-signature fields plugin.
Also, this article can be helpful:
Jira for CFR 21 Part 11 compliance: how to get audit trail for FDA inspection
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