New Annex 11 & Annex 22 in the Era of AI and Digital Transformation
Annex 11 & 22 / AI / Digital
Are you ready? New Annex 11 and Annex 22 in the era of AI and digitalization
Digitalization and AI are reshaping how we design, operate, and oversee quality systems across the pharmaceutical value chain. At the same time, the evolution of Annex 11 and the emergence of Annex 22 signal a clear regulatory shift: expectations for governance, validation, accountability, data integrity, and human oversight are increasing.
This is not only a compliance topic. It is a leadership topic.
For Quality, Regulatory, IT, and Operations leaders, the challenge is now to ensure that innovation moves forward with the right level of control, clarity, and responsibility. The organizations that will succeed are those that can combine digital ambition with strong governance and practical execution.
To understand what this means in practice, you will need to join the A3P Nordic event on 1 September 2026.
