What changed with FDA's September 2025 CSA final guidance, and how its risk-based approach differs from exhaustive CSV.
This course covers what changed with FDA's Computer Software Assurance final guidance issued in September 2025, how CSA's risk-based approach differs from traditional exhaustive computer system validation, GAMP 5 second edition software categories and how they inform testing rigor, and what genuine critical thinking documentation looks like in practice under CSA.
CSA's final guidance formalizes a shift many sites had already started informally: testing what actually matters for patient safety and product quality, not scripting every conceivable click. Sites still running legacy exhaustive CSV are spending validation effort where it adds the least value.
Completion certificate, PDF slide download, and access to the complete GMP course library from day one.
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