The European Commission released three significant documents on 7 July 2025: a draft revision of Annex 11, a revised Chapter 4 on documentation and records, and the brand-new Annex 22 on AI-based systems. These documents represent the most significant modernization of the EU GMP’s digital compliance framework in the last 14 years.
Since June 2011, the EU GMP Annex 11 has provided the compliance standard for pharmaceutical and biotech computerized systems. The document stipulated risk-based guiding principles that helped companies identify and utilize new technology systems. These technologies have evolved extensively over the last 14 years, driven by cloud computing, SaaS, mobile applications, and, importantly, artificial intelligence. The new Annex 11 – a detailed 19-page standard as opposed to the current 5-page guideline – includes, in fact, new technologies such as cloud computing and SaaS, as well as AI/ML-based systems.