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 ...
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 ...
On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
Continuous compliance: Rather than preparing for audits, agents continuously monitor validation completeness, test coverage, ...
Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...
Dublin, Oct. 28, 2025 (GLOBE NEWSWIRE) -- The "Computer System Validation (CSV) (Nov 4th - Nov 6th, 2025)" training has been added to ResearchAndMarkets.com's offering. Advancements in technology have ...
BOSTON--(BUSINESS WIRE)--Sware, provider of the most complete software validation solution for innovative life sciences companies, today announced that it raised $6 million in Series B funding, ...
Validate it? I just want to use it! Sound familiar? Most companies in the medical device industry understand and accept the need to validate software that is critical to the functioning of a medical ...
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