A guide to building AI agents in GxP environments

Healthcare and life sciences organizations are transforming drug discovery, medical devices, and patient care with generative AI agents. In regulated industries, any system that impacts product quality or patient safety must comply with GxP (Good Practice) regulations, such as Good Clinical Practice (GxP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP). Organizations must demonstrate to regulatory authorities that their AI agents are safe, effective, and meet quality standards. Building AI agents for these GxP environments requires a strategic approach that balances innovation, speed, and regulatory requirements.

AI agents can be built for GxP environments: The key lies in understanding how to build them appropriately based on their risk profiles. Gen AI introduces unique challenges around explainability, probabilistic outputs, and continuous learning that require thoughtful risk assessment rather than blanket validation approaches. The disconnect between traditional GxP compliance methods and modern AI capabilities creates barriers to implementation, increases validation costs, slows ...