E-signature
An electronic signature is data executed, adopted or authorised by a person as the legally binding equivalent of a handwritten signature. In FDA-regulated work, 21 CFR Part 11 Subpart C sets the controls; in EU GMP, Annex 11 clause 14 covers signatures within the company.
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01What Part 11 requires of an e-signature
- 11.50: the signed record shows the signer's printed name, date and time of signing, and the meaning (such as review, approval, responsibility or authorship).
- 11.70: signatures are linked to their records so they cannot be removed, copied or transferred to falsify a record.
- 11.100: each signature is unique to one person and not reused or reassigned; identity is verified before issue; the organisation certifies to FDA that its electronic signatures are intended to be legally binding.
- 11.200: non-biometric signatures use at least two distinct components, such as an ID code and password; in a continuous session the first signing uses all components and later signings at least one private component.
- 11.300: controls for ID codes and passwords, including uniqueness, periodic checks and loss management.
02US and EU
Annex 11 clause 14 says electronic signatures should have the same impact as handwritten signatures within the company, be permanently linked to their record and include the time and date. Clause 15 allows a Qualified Person to certify batch release electronically. EU legal recognition of signatures outside the company is governed by eIDAS, which this page does not cover.
FDA's 2018 Q&A confirms electronic signatures with appropriate controls can replace handwritten signatures in any CGMP record, including where 211.186(a) mentions a full handwritten signature.
03Worked example
A QA reviewer approves a batch record. The system asks for their user ID and password, then shows 'Approved — Jane Ortiz — 2026-10-04 14:32' on screen and in the printed record. If the record is changed later, the change is visible in the audit trail and the procedure requires a new review rather than letting the earlier approval stand silently.
04Common failure modes and checks
- Shared accounts, which break uniqueness under 11.100(a).
- Signature meaning missing from printouts or exports.
- No FDA certification letter under 11.100(c).
- Confusing an electronic signature with a cryptographic digital signature; Part 11 allows either if the controls are met.
05Where V5 fits
V5 provides electronic signing on configured steps with an audit history and role-based access, and supports two-signature formula approvals. Your organisation still issues and manages user identities, sends the Part 11 certification to FDA, defines which steps need signatures, and validates the configuration for its intended use.
Frequently asked questions
Q.What must a Part 11 e-signature display?+
The signer's printed name, the date and time, and the meaning of the signature (11.50).
Q.Do I need to tell FDA I use electronic signatures?+
Yes. 11.100(c) requires a certification that they are intended to be the legally binding equivalent of handwritten signatures.
Q.How many components does a password-based signature need?+
At least two, such as an ID code and a password (11.200(a)).
Q.Can a Qualified Person release a batch electronically in the EU?+
Annex 11 clause 15 allows electronic signature for batch certification.
Primary sources
Further reading
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Electronic records, signatures, audit trail and ALCOA+ data-integrity principles.
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