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 ...
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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
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 ...
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 ...
We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to validation by applying FDA's draft guidance for Computer Software Assurance (CSA) using an agile approach, ...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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