Implementing AI Systems In Regulated Pharma Environments

Artificial intelligence is reshaping the biopharmaceutical landscape, which offers new ways to accelerate innovation while maintaining compliance in a tightly regulated space. But deploying AI in GxP environments demands more than technical expertise—it requires a disciplined approach to risk, transparency, and governance. This ebook provides a practical framework for implementing AI systems that meet regulatory expectations and build trust across stakeholders. Grounded in the GAMP 5 machine learning lifecycle, it walks through every stage of AI development—from defining model objectives to managing data pipelines, selecting algorithms, and monitoring performance post-deployment.

Whether you're in IT, QA, MSAT, or data science, explore how to align innovation with compliance to unlock AI’s full potential in pharma.