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 ...
Market opportunities lie in integrating modern technology and agile methodologies to enhance compliance with FDA regulations. Emphasis on cloud services, validation approaches, and maintaining data ...
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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...
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 ...
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 ...
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 ...
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 ...
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