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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
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 ...
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 ...
Recently U.S. Army Europe's 5th Signal Command and the USAREUR directorate of information management sent an information infrastructure assistance team, or I2AT, to Schweinfurt, Germany to lighten the ...
Underdeveloped and non-existent computer security measures are having a dramatically negative impact on our society’s economic infrastructure. In response to this emerging technological area, ...
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