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.

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After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...

(MENAFN- GlobeNewsWire - Nasdaq) The main market opportunities include training on modern technologies for computer system validation, compliance with evolving FDA regulations, and risk-based ...

Dublin, Jan. 07, 2026 (GLOBE NEWSWIRE) -- The "CSA in Practice: How to Build Defensible Evidence the FDA Actually Wants to See (Jan 13, 2026)" training has been added to ResearchAndMarkets.com's ...