FDA Part 11 compliance - Support for electronic signatures

Summary

Some processes (especially those used in companies that are agency regulated) require username/password to be entered when performing certain tasks, such as transitioning an issue through workflow. Some systems support this already (Seapine Test Track Pro comes to mind), and it would be nice if JIRA did as well. Perhaps the solution could be adding a username/password type of field to workflow transitions.

Environment

Cloud environment

Expected Results

FDA Part 11 compliance

Actual Results

Jira and Confluence are not compliant out-of-the-box.

Notes

For the server environment there are various add-ons:

1. Comalatech using Comala Workflows - support contact.
2. AppFusion also provides through the Atlassian marketplace the CFR Part 11 E-Signatures (FDA Compliance) for Atlassian JIRA that adds an e-signature JIRA field and audit reporting to your workflow.
3. InLabs also provides Electronic Signature plugin to meet CFR Part 11.

Workaround:

There exist other apps in Marketplace that offer this. You can search Marketplace for these by searching the term CFR Part 11.