Defining the Baseline: Systems and Validation
May 19, 2026
Explore the FDA’s new software validation requirements and learn how the shift from traditional Computerized System Validation (CSV) to Computer Software Assurance (CSA) is transforming quality systems in life sciences and digital health. Discover risk-based validation strategies, agile testing methods, 21 CFR Part 11 compliance, GAMP 5 alignment, automated validation tools, SaMD guidance, post-market surveillance, and best practices for modern FDA software quality assurance.