Computer software assurance (CSA), the FDA's new framework for computer system validation (CSV), is being heralded as a game-changer. While the promise of simplified, less costly validation is ...
After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...
In 2025, the U.S. Food and Drug Administration finalized guidance on Computer Software Assurance (CSA), explicitly endorsing a risk-based framework for software used in device production and quality ...
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