Annex 11 is part of EudraLex Volume 4. Compared with 21 CFR Part 11, which is built around electronic records and signatures, Annex 11 takes a whole-lifecycle view of a system and expects documented risk management, supplier assessment and periodic evaluation. As of October 2026, the 2011 version is still the one in force. A substantially rewritten draft was published for consultation in July 2025, alongside a revised Chapter 4 and a new Annex 22 on artificial intelligence.

Why it matters for labeling

Tools used to verify or approve labeling for medicines in the EU fall under it. Annex 11 expects the supplier of a system to be assessed and the system to be reviewed periodically, two requirements that companies relying on Part 11 documentation alone often miss.

Common mistakes

  • No supplier assessment for cloud or SaaS tools
  • No periodic review records
  • Validation documentation written only around records and signatures, not the whole system
  • Assuming Part 11 compliance is enough for the EU

Sources