Meeting The FDA's New CSA Guidance For Validation

By Kelly Stewart

CSA, or Computer Software Assurance, is a modern approach to software validation spearheaded by the FDA and drafted in 2022. This approach is intended to reduce the documentation burden of the previous Computer Systems Validation (CSV) method, but not at the expense of product quality or safety.

Through the application of critical thinking, or rigorous and ongoing data evaluation, pharmaceutical companies can use CSA to ensure compliance without getting weighed down by the overdocumentation previously demanded by CSV.

The FDA recently released new draft guidance on CSA validation. Read on to learn about the latest FDA guidance on software validation, and how we’ve future-proofed our software to stay on top of these evolving regulations.