What does FDA · 21 CFR Part 11 cover?

Electronic records & signatures. It applies to: Pharma / medical under FDA.

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FDA · 21 CFR Part 11

Electronic records & signatures.

Instrument: Regulation, legally bindingApplies to: Pharma / medical under FDA.

What the signed record shows

A secure, time-stamped, signed audit trail of electronic records and signatures.

The proof is a signed, tamper-evident record. Anyone can check it, without an account, and nothing has to leave the building to make it. Evidence, not a promise.

Citation: §11.10(b)(c)/(e), 11.50, 11.70, 11.100

In the same family

EU GMP · Annex 11Computerised-systems integrity FDA-EMA · Good AI Practice (Jan 2026)Data governance, performance, life-cycle management FDA · GMLPGood Machine Learning Practice

What to do about it

Keep the evidence this asks for, as the work happens.

A consequential AI-proposed action is checked against the human authority in force at that moment, and the decision leaves a signed record that a third party can verify independently, offline, without Regulayer™. It runs inside your own environment and nothing has to leave it.

Life sciences: how the control works Or verify a real record →

Part of the Regulayer™ proof catalogue: 156 laws and standards, one sealed engine. This page is a product description, not legal advice.

What the statute requires, section by section

U.S. Food and Drug Administration, Title 21 of the Code of Federal Regulations, Part 11, Electronic Records; Electronic Signatures. Subparts addressed:

21 CFR 11.10(b)/(c): Controls for closed systems: the ability to generate accurate, complete copies of records and to protect records to enable their accurate and ready retrieval throughout the retention period.
21 CFR 11.10(e): Use of secure, computer-generated, time-stamped audit trails to independently record operator entries and actions that create, modify, or delete electronic records.
21 CFR 11.50: Signature manifestations: signed records shall contain the printed name of the signer, the date and time of signing, and the meaning associated with the signature.
21 CFR 11.70: Signature/record linking: electronic signatures shall be linked to their respective records so they cannot be excised, copied, or otherwise transferred to falsify a record.
21 CFR 11.100: Electronic signature general requirements: each electronic signature shall be unique to one individual.

Taken from the Regulayer™ entry for this instrument, which is built against the primary text.