Meet Requirements of 21 CFR 11: Electronic Records; Electronic Signatures

[#1]

Description - Meet the requirements for electronic records and electronic signatures as stated in 21 CFR Part 11

Why is this feature important to you - This would likely enable wider adoption of the platform for use in highly regulated industries, like nutritional supplements and pharmaceuticals, that are subjected to these requirements. I suspect several of the primary requirements are already being met.

How would you like the feature to work - If the platform supported electronic signatures compliant with 21 CFR Part 11, I could see request queues and approval paths integrated to manage quality documentation in the industries subjected to these requirements (product specifications, product labels, certificates of analysis, etc).

Current Behaviour - approval paths not 21 CFR Part 11 compliant for electronic signature standards.

[#2]

@quarkmage, how topical, we are looking into the same thing!

Are you speaking to the basic document approval cycle built into Workfront, or proof approvals in Workfront Proof?

We were told the proof approvals for the packaging mechanicals are what need to comply, or at least that is the baseline, short-term compliance goal.

I believe Workfront Proof has digital signatures, but only if you are using SSO, which is something we have to work on. But we haven't looked closer to see if those signatures are enough for 21 CFR Part 11 compliance.

If you want to compare notes, feel free to look me up. Messy, complex topic; *bleh*.

[#3]

Thanks for engaging in the discussion @CalvinFold . I am not familiar with SSO, but see in the system menu that we have none enabled on our platform, so i may have to take a closer look at that and learn more.

I can see two distinct paths, Proof Approvals, and Approvals through established approval paths.

I would have to enable some SSO and follow it through to see the process and critique in connection to the CFR, but am surely not comfortable trying that at this time...(again, time to learn more!). Thanks.