21 CFR Part 11 – Electronic Signatures - Online Course
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21 CFR Part 11 – Electronic Signatures - Online Course
The FDA considers Part 11 to be applicable to e-signatures that are intended to be the equivalent of: • Handwritten signatures, • Initials, • And other general signings required by the predicate regulations impacting computer systems Part 11 signatures also include e-signatures used to document that certain events or actions occurred in ...
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