Compliance
E-signature
electronic signature · e-sig
Cryptographic substitute for a wet signature, with re-authentication and meaning bound to the record.
An electronic signature under 21 CFR Part 11.200 must include the printed name of the signer, date and time of execution, and the meaning (review, approval, responsibility). It must require at least two distinct identification components (e.g. password + biometric) for the first signing in a session, and re-authentication for subsequent signings.
V5 enforces all of these for every approval, two-person review, batch release, deviation closure and document approval.
Regulatory anchors
- 21 CFR 11.50
- 21 CFR 11.200
Related terms
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