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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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 ...
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 ...
After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...
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 ...
We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to validation by applying FDA's draft guidance for Computer Software Assurance (CSA) using an agile approach, ...
Blood Assurance partners with BBCS to implement ForLife Biologics PlatformTM, streamlining operations & enhancing donor experiences. BONNEY LAKE, WA, UNITED STATES, September 2, 2025 /EINPresswire / - ...
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