At the 2026 PDA/FDA Joint Regulatory Conference, representatives from the US Food and Drug Administration (FDA), Sanofi and Gilead Sciences discussed how pharmaceutical manufacturers can assess manufacturing data readiness for artificial intelligence (AI), maintain data integrity and apply risk-based validation to digital tools used in current good manufacturing practice (CGMP) environments. The session, “Advancing Digital Tools and Data Utilization in a CGMP Environment,” covered data maturity in biologics manufacturing, quality-unit oversight and the appropriate level of validation for AI applications. The conference took place in Washington, DC, from 14 to...