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After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...

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 ...

The administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for the upcoming financial year. The list of draft documents touches on many topics ...

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