What does FDA · 21 CFR Part 11 cover?

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

What does the Regulayer pack for FDA · 21 CFR Part 11 prove?

A secure, time-stamped, signed audit trail of electronic records and signatures. The record is signed and tamper-evident, and anyone can verify it free, without an account.

Regulayer / The 114 laws / Pharma & life sciences

FDA · 21 CFR Part 11

Electronic records & signatures.

Applies 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, free, 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

Seven days free, then $349 a month.

A signed record of which AI you used and what you checked, sealed to the exact file you deliver, made on your own machine and checkable free by anyone you send it to.

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Part of the Regulayer proof catalogue: 114 laws and standards, one sealed engine. This page is a product description, not legal advice.