Future-Proof Your GMP Digital Systems 

Understand the updated Annex 11, Chapter 4, and new Annex 22 and how they will affect your pharmaceutical operations and approach to digital compliance in the age of AI.

Download the guide and learn what the new Annex 11 draft expectations mean for your computerized systems, data, and operations ahead of the 2026 enforcement date.
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Annex 11 R-Evolution preview

What's included

  • check mark Get a clear explanation of what is changing and how these updates will impact your validation, data integrity, supplier oversight, and digital governance. 
  • check mark See how Annex 11, Chapter 4, and Annex 22 work together, and learn the strategies you can use to prepare your systems, documentation, and processes. 
  • check mark Discover practical steps to help your organization meet the new GMP expectations, including lifecycle management, audit trails, security, AI oversight, and cloud readiness. 

Want to know more?

PQE Group's global presence, unmatched regulatory expertise, and tailored digital governance services mean that no matter where your operations are, you are guaranteed the same high level of quality and compliance we are known for, helping you prepare for any regulatory changes.