CARY, N.C., Dec. 16, 2025 /PRNewswire/ -- InstantGMPâ„¢, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its ...
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After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...