FDA 21 CFR Part 11 compliant e-signatures
Part 11 sets the FDA's rules for electronic records and electronic signatures. On the Regulated plan, Traceable's e-signatures meet them, with the audit trail and record controls built in, so the signature record an inspector asks for is already there.
FDA 21 CFR Part 11 requires electronic records to be trustworthy and electronic signatures to be as binding as handwritten ones. On the Regulated plan, Traceable's e-signatures are Part 11 compliant: each is confirmed with a one-time code, records the signer, the meaning and the time, and is locked with the published document in an attributed audit trail.
What Part 11 asks for, and how Traceable meets it
| Clause | What Part 11 asks for | In Traceable |
|---|---|---|
| 11.10(e) | Secure, computer-generated, time-stamped audit trails that record who changed a record, and when, without obscuring what was there before. | Every change is attributed in a row-level change log, and earlier versions stay viewable and recoverable. |
| 11.10(c) | Records protected so they can be retrieved accurately throughout their retention period. | Each publication locks an immutable PDF snapshot of exactly what was approved, held in private storage. |
| 11.10(d) | Access limited to authorised individuals. | Every read and write checks organisation and project membership, and Row Level Security on every table blocks access from outside the application. |
| 11.50 | Each signature shows the signer’s name, the date and time, and the meaning of the signature, such as review or approval. | Each signature records who signed, in what role, and when, and the published document carries it. |
| 11.70 | Signatures linked to their records so they cannot be removed, copied or transferred to falsify a record. | A signature belongs to the document version it signs, and publishing locks that version with its signatures. |
| 11.200 | Electronic signatures that use at least two distinct identification components. | Signing needs the signer’s own sign-in and a one-time code sent to their email, so a signature confirms the person, not just the session. |
What Part 11 asks of your team
Part 11 also asks things of the regulated company, whatever software it uses: that its computerised systems are validated for their intended use (11.10(a)), that people who use electronic signatures are trained and accountable for them under written policies (11.10(i) and (j)), and that the company certifies to the FDA that its electronic signatures are the legally binding equivalent of handwritten ones (11.100(c)).
Traceable is built to make that work light. Its signing, audit trail and record controls are in place from the first document, and our security and privacy page sets out how the platform is protected and tested.
Common questions
Are Traceable e-signatures 21 CFR Part 11 compliant?
Yes. On the Regulated plan, Traceable has FDA 21 CFR Part 11 compliant e-signatures: two-step signing, timestamped and attributed records, and an immutable audit trail.
Which plan includes Part 11 signing?
The Regulated plan includes 21 CFR Part 11 signing and distinct signers on every review. See pricing for the plans side by side.
Does Part 11 apply outside the United States?
Part 11 is an FDA regulation, so it applies to records submitted to or required by the FDA. Teams selling into the US market often adopt it as their standard for electronic records everywhere, alongside ISO 13485 and EU Annex 11.
Sign and publish with confidence
Put a real document through review, Part 11 signing and publishing, and see the record it leaves.