EU GMP Annex 11 has governed computerised systems since 2011, the year before most companies moved anything to the cloud. In July 2025 the European Commission and PIC/S published a complete rewrite, together with a new Chapter 4 on documentation and a first-ever annex on AI. The final texts are still pending, but the drafts already tell inspectors and quality teams where the bar is moving.
Where things stand
The three drafts were released on 7 July 2025 with a three-month consultation. As of August 2026, EudraLex Volume 4 still lists Annex 11 in its 2011 version, and no adoption or effective date has been published. That gives sites a window: the direction is known, and the work it implies is large enough that it should start before the final text arrives.
What is new in draft Annex 11
What is new in draft Chapter 4
The documentation chapter grows from paperwork rules into data governance. It formally recognises hybrid systems that mix paper and electronic records, applies ALCOA++ principles, and ties documentation systems directly into the pharmaceutical quality system. It adds expectations on data lifecycle and metadata control, template control and validation, role-based access and timestamps, audit trails for entries and changes, digital signatures, version control, and long-term readability of digital records, with a new glossary that defines terms such as metadata and certified copy.
The message of both drafts is the same: data integrity is not a project you finish. It is a property of how your systems and documents are governed every day.
A readiness roadmap
Want a first view of your computerised systems and documentation maturity? Our free GMP Mock Audit includes areas for documentation, data integrity and computerised systems. For a full gap assessment against the drafts, contact our team.