How to Use Agentic AI to Systematically Prevent Deviations

Artificial intelligence (AI) is already writing code, generating requirements, and suggesting test cases — but how do RA/QA teams maintain oversight when these tools operate inside regulated workflows? This session explores how to ensure traceability, enforce QMS requirements, and validate AI-generated outputs using a risk-based approach. We will share best practices and walk through a real-world case study showing how teams have successfully embedded compliance into their development tooling.