EU GMP Annex 11 revision: Computerised Systems (draft)

Context and history

This is a full rewrite of Annex 11, not a light update. A concept paper appeared in November 2022, and the draft was published for public consultation on 7 July 2025, closing on 7 October 2025. It was prepared jointly by the EU GMP/GDP Inspectors Working Group and the PIC/S Committee, so the intention is one common approach across EU and PIC/S authorities.

The stated reasons are changes in regulatory and manufacturing environments, growing use of cloud services, new technologies, and the need to remove ambiguity and inconsistency. It grows from about five pages to about nineteen and is far more prescriptive, particularly on identity and access, audit trails, security and cloud-based services.

It was published with the revised Chapter 4 and the new Annex 22 on AI, and the three are designed to work together. It is still a draft: nothing in it applies yet, the text may change, and the 2011 Annex 11 remains in force.

Who and what it applies to

All types of computerised systems used in manufacturing medicinal products and active substances. The draft speaks to regulated users, and it extends to suppliers and service providers through oversight and contracts.

Alternative practices may be used if they are proven and documented to give the same or a higher level of control.

Not covered: Anything beyond computerised systems used in manufacturing medicinal products and active substances. AI models are dealt with in draft Annex 22.

What it contains

1. Scope

All computerised systems used in manufacturing medicinal products and active substances.

2. Principles

Lifecycle management, quality risk management, alternative practices, data integrity under ALCOA+, system requirements, outsourced activities, security, and no increase in risk.

3. Pharmaceutical quality system

Places system management inside the pharmaceutical quality system.

4. Risk management

Risk management across the lifecycle: identification and analysis, appropriate validation, mitigation, and data integrity.

5. Personnel and training

Cooperation between roles, and training.

6. System requirements

GMP functionality, extent and detail, ownership, keeping requirements updated, traceability, and configuration.

7. Supplier and service management

Regulated user responsibility, audit, oversight, documentation availability and contracts.

8. Alarms

A new section: reliance on alarms, settings, signalling, acknowledgement, logs, searchability and review.

9. Qualification and validation

Principles, risk management, installation and configuration, evidence, traceability, focus, planning and approval, completion before use, and authorisation.

10. Handling of data

Input verification, transfer, migration and encryption.

11. Identity and access management

Unique accounts, continuous management, certain identification, confidential and secure passwords, strong authentication, auto locking, inactivity logout, access logs, guiding principles and recurrent reviews.

12. Audit trails

Manual user interactions, recording who, what, when and why, no editing or deactivation, review support, independent review, scope and timeliness, electronic copies, and availability to the Qualified Person.

13. Electronic signatures

Scope, open systems, re-authentication, date and time, meaning, manifestation, indisputability, an unbreakable link, and hybrid solutions.

14. Periodic review

Periodic reviews, their scope and frequency.

15. Security

The longest section: security system, improvement, training and tests, physical access, disasters, replication, disaster recovery, segmentation and firewalls, platforms and patching, scans, ports, anti-virus, penetration testing and encryption.

16. Backup

Regular backup, frequency and retention, physical and logical separation, scope, and restore tests.

17. Archiving

Read-only archives, verification, backup, durability and retrieval.

Glossary

Defined terms.

Key points

• The draft moves from principles to detailed expectations, with far more prescribed controls.
• Security becomes a major topic, covering firewalls, patching, penetration testing, disaster recovery and encryption.
• Audit trails are expected to capture who, what, when and why, and cannot be edited or deactivated.
• Alarms get their own section for the first time.
• Identity and access management is spelled out, including unique accounts and strong authentication.
• Periodic review stays, and backup and archiving are separated more clearly.
• ALCOA+ is named as the data integrity framework.
• It must be read with the revised Chapter 4 and new Annex 22.
• Nothing here applies yet. Only the final text will, once published and in operation.

In practice

General reading, not advice. This is drafted with AI and may not fit your situation. It does not replace the official text, your own quality system or qualified advice, and an inspector may take a different view.

• Use a gap review against the draft to plan budgets for systems due for replacement, knowing the final text may differ.
• Security is likely to be the biggest change for many sites, and IT and OT security teams may need to be involved earlier than QA is used to.
• Review legacy systems that cannot deliver unique accounts or locked audit trails, as these may be hardest to bring into line.
• Check supplier contracts and cloud agreements, because the draft expects more oversight and evidence.
• Do not change validated systems purely for a draft. Wait for the final text before formal commitments.

Read from the source document on 1 Nov 2026. This is our own description, not the official text. Check the full dated history in the change log below.