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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...

The market opportunities lie in providing comprehensive training for computer system validation aligning with FDA regulations, offering hands-on practice, agile and waterfall methodologies comparison, ...

Gerard Holzmann at Bell Labs, Software to detect bugs in networked computers; Charles Howell at Mitre, Benchmarks for software assurance; Charles Simonyi at Intentional Software, Programming tools to ...