Industry Insight
The Impact of Artificial Intelligence on CQV
As artificial intelligence (AI) technologies mature, their application in commissioning, qualification, and validation (CQV) is becoming not only more practical, but increasingly necessary.
This Industry Insight explores three critical areas where AI is influencing the CQV lifecycle: documentation automation, real-time execution and monitoring, and predictive quality management. It examines how AI tools are helping reduce manual effort in protocol development and review, enabling adaptive execution with real-time feedback, and providing early warning signals through anomaly detection and predictive analytics.
Importantly, it considers how these innovations can be implemented within existing regulatory frameworks, including evolving guidance from the FDA, EMA, and PIC/S.
For CQV professionals navigating digital transformation, this piece offers a timely, grounded perspective on how AI is changing the shape of validation today.