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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
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 ...
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 ...
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, ...
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 ...
The certification that a computer is operating according to specification. It includes the observation of the hardware, software, connected instruments, as well as the practices trained staff employ ...
Asthe SoC (systems-on-chip) complexity continues to increase, it is nolonger possible to ignore the challenges caused by the convergence ofsoftware and hardware development. These highly functional ...
With car companies adding more cameras, digital display screens, active safety systems and other technology to their vehicles with each passing year, they are starting to rely more and more on ...
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