Category: Configuration, compliance, and auditing

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.

This is joint post co-written by Leidos and AWS. Leidos is a FORTUNE 500 science and technology solutions leader working to address some of the world’s toughest challenges in the defense, intelligence, homeland security, civil, and healthcare markets. Leidos has partnered with AWS to develop an approach to privacy-preserving, confidential machine learning (ML) modeling where […]