What does EU GMP · Annex 11 cover?

Computerised-systems integrity. It applies to: Pharma manufacturing (EU).

What does the Regulayer pack for EU GMP · Annex 11 prove?

System-generated audit trails, access control, archived integrity for GMP-relevant actions. The record is signed and tamper-evident, and anyone can verify it free, without an account.

Regulayer / The 114 laws / Pharma & life sciences

EU GMP · Annex 11

Computerised-systems integrity.

Applies to: Pharma manufacturing (EU).

What the signed record shows

System-generated audit trails, access control, archived integrity for GMP-relevant actions.

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: Annex 11 §7/§9/§12/§17

In the same family

FDA · 21 CFR Part 11Electronic records & signatures FDA-EMA · Good AI Practice (Jan 2026)Data governance, performance, life-cycle management FDA · GMLPGood Machine Learning Practice

What to do about it

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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.