Computer Software Assurance guidance for quality system
May 19, 2026
Learn how modern Computer Software Assurance (CSA) guidance is transforming FDA software validation for life sciences and digital healthcare. Discover the shift from traditional Computerized System Validation (CSV) to risk-based testing, continuous monitoring, agile validation, cybersecurity protection, 21 CFR Part 11 compliance, audit trails, and Software as a Medical Device (SaMD) oversight. Understand how these evolving FDA validation requirements improve patient safety while accelerating innovation in connected medical technology.