GAMP® 5 Second Edition and Beyond: A Holistic Approach to AI

Technological capabilities and regulatory requirements around AI are constantly evolving. The GAMP 5 2nd Edition acknowledges this by its dedicated, new appendix D11 - Artificial Intelligence and Machine Learning. As contributors to this version of the GAMP 5, we will provide an overview on those new concepts in this talk, while we will go one step further, as we will augment this guidance by our results from the GAMP D/A/CH special interest group, summarizing the essence of our article series in the ISPE Pharmaceutical Engineering on the AI maturity model, the AI governance framework and further operational blueprints where we elaborate on the idea of Good Machine Learning Practices in regulated areas.