Electronic signatures in GxP are legally binding, individually attributed signatures in electronic records , governed by 21 CFR Part 11 and EU Annex 11 compliance requirements.
Definition
Electronic signatures in a GxP context are legally binding signatures executed through electronic means , a typed name, PIN, or biometric identifier , that are attributed to an individual and linked to an electronic record. Under 21 CFR Part 11 and EU Annex 11, electronic signatures must be uniquely linked to the signer, applied at the time of signing, and protected against unauthorised use. They are not the same as digital signatures, which use cryptographic keys.
What this means when you're hiring
Electronic signature configuration is a common compliance failure point in MES implementations. I ask about it because weak or misconfigured e-signature workflows , shared credentials, unsigned batch records, missing signature meaning fields , are exactly what FDA inspectors look for. Engineers who've configured compliant e-signature workflows understand the practical implications, not just the regulatory requirement.
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