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tolatola Anyone 21 CFR Part 11 compliant?
We have a project to move some of our paper processes to electronic processes
We've gotten the Salesforce white paper on the topic and still have some questions
Namely, how did you enforce the e-signature?
Do you have users re-authenticate when approving?
Do you use a component or third party to process e-signatures?
What kind of timeline and cost was associated with deploying that?
There are other interpretation questions, but the big hurdle (as I see it) is the electronic signature
Total Newbie, did you get much support from the community regarding your effort to show 21 CFR 11 compliance? I have just taken on that project and was wondering if you had found any resources you could point me towards. Thanks in advance for any information you can provide.