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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

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 ...

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 ...

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 ...

The Computer Software Assurance (CSA) industry is experiencing rapid digital transformation as organizations prioritize robust software validation and compliance. Growing regulatory mandates and the ...

SCHWEINFURT, Germany (Dec. 5, 2007) -- Over the past several years the U.S. Army has invested billions of dollars in computer software, hardware and equipment to keep up with the world's ever-changing ...

NEW YORK--(BUSINESS WIRE)--Computer Design & Integration LLC (“CDI” or “the Company”) today announced that it has received the MSPAlliance® Cyber Verify™ Risk Assurance Rating for Managed Services and ...