Insights

Learn how the FDA’s new software validation requirements are transforming life sciences, medical devices, and digital health. This guide explains the shift from traditional Computer System Validation (CSV) to Computer Software Assurance (CSA), including risk-based testing, Agile validation, automated testing for GxP environments, 21 CFR Part 11 compliance, audit trails, SaMD regulations, and post-market surveillance strategies. Discover how modern FDA guidance helps organizations reduce documentation burdens while improving software quality, patient safety, and compliance efficiency.