Confluence 21CFR Part 11 compliance

Jeannette Lamb

We are using Confluence for document management with the ad-hoc workflows plugin for workflow and approvals.

I'm trying to find out if we need to add something else to achieve 21 CFR Part 11 compliance. Specifically, does a password need to be entered for every signature or is a single login sufficient?

If a password needs to be entered each time, does anyone know of any plugins that would enforce this?

Thanks,
Jeannette

Miguel Reimer

Hi Jeannette,

Ad hoc Workflows has the capability to require the user enter their username and/or password every time they want to approve or reject an approval. Our understanding is that you need to re-enter both the username and password, as that is what our other clients in similar situations use, but if you are not sure what you need to use, I'd recommend discussing this with your auditor.

If you want this feature active, you need to add "credentials" parameter to the Approval macro in the workflow markup. Use "credentials=1" to require just the password or "credentials=2" to require the username and password every time the user approves or rejects an approval.

Example:

{approval:Approval name|credentials=2|...}

Thanks,
Miguel