CSV to CSA Software Assurance 2026 – Understanding the transition from CSV to CSA in FDA-regulated industries

Summary: This training explains the shift from traditional Computer System Validation (CSV) to Computer Software Assurance (CSA) for FDA-regulated industries, focusing on risk-based validation, 21 CFR Part 11 compliance, and data integrity. It provides practical guidance on implementing CSA and evolving validation documentation.

What it does

It delivers expert-led instruction on risk-based validation strategies, regulatory expectations, and practical steps for transitioning from CSV to CSA in regulated environments.

Who it's for

Quality, validation, IT, and compliance professionals working with FDA-regulated computer systems.

Why it matters

It addresses challenges with over-documentation and audit uncertainty by clarifying CSA’s risk-based approach and compliance requirements.