Is there a checklist for Jira cloud to become CFR 21 Part 11 compliant?

Question

My company has asked me to write up a gap analysis on our instance of Jira Cloud and what it would take to become CFR 21 Part 11 (parts a and b) compliant. 
I've done an initial website and AI searches on the topic, but I believe speaking with an Atlassian resource that has helped in this capacity in the past is probably the best path forward to a complete picture.

William Huntwork · Answer

Excellent, thanks for the insight Marc!

marc -Collabello--Phase Locked- · Answer

Hi @William Huntwork ,

While I can't provide complete guidance, you can have a look at https://www.phaselockedsoftware.com/en/document-control/doc/#fda .  This link shows how our addon for Confluence (thus not Jira) handles CFR Part 11.

One important thing is to be sure what must be handled by Jira, and what by organizational controls etc.