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 ...
CARY, N.C., Dec. 16, 2025 /PRNewswire/ -- InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its ...
After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...
The "Computer System Validation (CSV) Training Course (Jan 27th - Jan 29th, 2026)" training has been added to ResearchAndMarkets.com's offering. A course designed to completely immerse you in computer ...
Dublin, Jan. 06, 2026 (GLOBE NEWSWIRE) -- The "Digital Validation and Cloud Assurance: Validating SaaS, PaaS and Automated Pipelines under CSA - Modular Course for Practitioners (Jan 21st - Jan 26th, ...
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.