Navigate FDA’s New Software Validation Requirements
May 19, 2026
Navigate the FDA’s new software validation requirements with confidence. Learn how the shift from traditional Computer System Validation (CSV) to Computer Software Assurance (CSA) is transforming software compliance in life sciences, medical devices, and pharmaceuticals. Discover risk-based testing strategies, 21 CFR Part 11 compliance, audit trails, IEC 62304 lifecycle standards, cloud validation, agile development, and best practices for modern FDA software quality audits.