A guide to building AI agents in GxP environments

The regulatory landscape for GxP compliance is evolving to address the unique characteristics of AI. Traditional Computer System Validation (CSV) approaches, often with uniform validation strategies, are being supplemented by Computer Software Assurance (CSA) frameworks that emphasize flexible risk-based validation methods tailored to each system’s actual impact and complexity (FDA latest guidance). In this post, we cover a risk-based implementation, practical implementation considerations across different risk levels, the AWS shared responsibility model for compliance, and concrete examples of risk mitigation strategies.