The pharmaceutical industry has traditionally relied on rigid GxP frameworks where software validation was binary—systems either worked as programmed or failed—but the rise of ML and AI has disrupted this model, prompting the European Commission to introduce Annex 22 under EudraLex Volume 4 to regulate AI-based manufacturing systems; for QA professionals and data scientists, Annex 22 is not merely a new guideline but a fundamental shift in how the reliability and “truth” of
