InstantGMP categorizes software functions into low, moderate, and high process-risk groups. Low-risk features, such as equipment, room, deviation, and CAPA logs, primarily collect or tabulate data.

After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...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 ...