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 146 laws / Pharma & life sciences

EU GMP · Annex 11

Computerised-systems integrity.

Instrument: GMP annex, legally binding in the EUApplies 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

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, free →

Part of the Regulayer proof catalogue: 146 laws and standards, one sealed engine. This page is a product description, not legal advice.

What the statute requires, section by section

EudraLex Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 11, Computerised Systems. Clauses addressed:

Annex 11 §7: Data storage: data should be secured against damage and loss; accessibility, readability and accuracy checked.
Annex 11 §9: Audit trails: consideration of a system that records all GMP-relevant changes and deletions (a "system generated audit trail").
Annex 11 §12: Security: physical and/or logical controls to restrict access to authorised persons, and recording of operator actions (creation, change, confirmation of data).
Annex 11 §17: Archiving: data may be archived; integrity and accessibility of the data must be checked over the retention period.

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