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After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...

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