Electronic Signature
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
An electronic signature is a computer data compilation that an individual adopts as the legally binding equivalent of their handwritten signature. Under GxP records rules it must be uniquely attributable to one person, permanently linked to the record it signs, and show the signer’s name, the date/time, and the meaning of the signing (e.g. authorship, review, approval).
Signatures based on identification codes plus passwords require controls ensuring uniqueness, that credentials are periodically checked/changed, and that no individual can use another’s. Biometric signatures must be designed so they cannot be used by anyone other than their genuine owner.
The signature manifestation must appear on human-readable and electronic copies of the record and cannot be excised, copied, or transferred to falsify another record. A wet-ink signature scanned into a system is not an electronic signature in the regulatory sense.
- —Uniquely attributable; never shared or reusable by another person.
- —Permanently linked to the signed record.
- —Shows signer name, date/time, and meaning of the signing.
- —Manifested on both human-readable and electronic copies.
21 CFR Part 11 §§11.50, 11.70, 11.100–11.300 (electronic signature requirements); EU GMP Annex 11 §14 (electronic signatures).
Frequently asked questions
What is Electronic Signature?
An electronic signature is a computer data compilation that an individual adopts as the legally binding equivalent of their handwritten signature. Under GxP records rules it must be uniquely attributable to one person, permanently linked to the record it signs, and show the signer’s name, the date/time, and the meaning of the signing (e.g. authorship, review, approval).
Which regulations cover Electronic Signature?
21 CFR Part 11 §§11.50, 11.70, 11.100–11.300 (electronic signature requirements); EU GMP Annex 11 §14 (electronic signatures).