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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

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 ...

After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...

Blood Assurance partners with BBCS to implement ForLife Biologics PlatformTM, streamlining operations & enhancing donor experiences. BONNEY LAKE, WA, UNITED STATES, September 2, 2025 /EINPresswire / - ...

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 ...