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FDA 21 CFR Part 11 - Anyone have any experience
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Have a group that's getting ready to start with our LMS, but they have some requirements for 21 CFR Part 11 compliant systems/processes.
Wondering if anyone out there has implemented (and what the experience was like).
Some things are concerning, but I don't know enough about the process to know how concerned to be.
- We use SSO so users don't know their randomly generated passwords, but password appears to be a required component to the e-signature.
- The rules look to be all or nothing, so not sure if I could only require the e-sig for a course or set of courses.
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