JD Supra

FDA’s Draft Computer Software Assurance Guidance Changes the Game for Quality System and Production Software Validation

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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

FDA finalizes computer software assurance guidance for production and quality system software

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 ...
FiercePharma

Worried About Computer Software Assurance? Relax, You're Probably Already Doing It

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 ...
BioWorld

Ambiguity a sticking point for industry in FDA’s computer software assurance draft

After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...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

Microsoft boosts benefits for Software Assurance agreement holders

Microsoft Corp. yesterday unveiled a new package of benefits that it plans to start offering in September to customers that purchased its controversial Software Assurance agreement to gain upgrade ...