Computer Software Assurance (CSA) guidance

🚀 “Less paperwork, more assurance.” The FDA’s final Computer Software Assurance (CSA) guidance is here — and it’s reshaping how we approach computerized system validation in regulated industries.

Published back in September 2025, many professionals have already taken the time to study it, analyze the intent, and test its practicality. Now that the dust has settled — what do you think? 👉 Have you started applying the new approach? 👉 Did you explore the management tables and examples at the end of the guidance?

🔍 Three key areas worth paying attention to: 1️⃣ Digital Evidence – system logs and audit trails are now recognized as valid validation evidence. 2️⃣ Vendor Assurance & Cybersecurity – supplier oversight and cloud control are part of the quality system, not an afterthought. 3️⃣ Alignment with ISO 13485 (QMSR 2026) – all validation processes must now fit within the unified quality framework.

And for those who adopted risk-based validation long before it was fashionable — this update isn’t a surprise, but it’s certainly a welcome alignment.

💡 The document also includes practical examples (LMS, PLM, Nonconformance, BI) and smart management tables to support implementation.

What’s your take — does CSA truly simplify validation, or just shift the focus?

#FDA #CSA #ComputerSoftwareAssurance #CSV #DataIntegrity #MedicalDevices #GxP #QualitySystems #Validation #DigitalTransformation #RegulatoryCompliance