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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
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 ...
As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by industry on compliance rather than quality may be diverting resources and ...
SCHWEINFURT, Germany (Dec. 5, 2007) -- Over the past several years the U.S. Army has invested billions of dollars in computer software, hardware and equipment to keep up with the world's ever-changing ...
The Computer Software Assurance (CSA) industry is experiencing rapid digital transformation as organizations prioritize robust software validation and compliance. Growing regulatory mandates and the ...
Providing an adequate level of IT assurance for legal industry leaders has become a high-profile challenge, as firms of all sizes find themselves on the front lines of the global ransomware war. Just ...
DUBLIN--(BUSINESS WIRE)--The "The FDA Recently Released a New Draft Guidance Related to Part 11" webinar has been added to ResearchAndMarkets.com's offering. As part of the Case for Quality program US ...
Although the pharmaceutical industry works to the same regulations there are wide differences in company interpretations. Often the interpretation for CSV can be inflexible, onerous, slow and a ...
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