Webinar: A Deep Dive into Annex 11 and 22
In this 45-minute webinar, you’ll get a practical walkthrough of the major changes coming with EU GMP Annex 11 and the new Annex 22. Learn what regulators expect when it comes to cloud systems, data governance and AI.
Key Takeaways
These changes aren’t just regulatory formalities. They reshape what compliance looks like across IT, QA and data science – and place new demands on your teams, processes and suppliers.
The most significant changes in Annex 11
Extending validation and compliance expectations beyond go-live and across system operation, maintenance, and decommissioning. It also reinforces accountability for supplier oversight, data integrity,
What Annex 22 means for AI, machine learning and explainability
Organizations must be able to demonstrate how AI decisions are made, validated, monitored, and kept under human oversight
What regulators expect when you use SaaS or AI-based tools
Regulators make it clear that responsibility cannot be outsourced - accountability remains with the regulated company, even when using cloud or AI services.
For years, Annex 11 has been the backbone of how Life Science companies manage computerized systems under EU GMP.
Now, for the first time since 2011, it’s changing and it’s not alone.
With the introduction of Annex 22, regulators are, for the first time, setting formal expectations for how AI and machine learning can be used in GxP environments. Together, these updates represent one of the most significant shifts in EU GMP in decades.
But beyond the headlines, what do these changes really mean for your systems, your data, and your day-to-day compliance responsibilities?
Join Epista Life Science and Henrik Johanning for a practical, session where we break down the essentials of both annexes and, most importantly, what you should start doing now to stay inspection-ready
