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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

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 ...

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 ...

In 2025, the U.S. Food and Drug Administration finalized guidance on Computer Software Assurance (CSA), explicitly endorsing a risk-based framework for software used in device production and quality ...

After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...

Microsoft Corp.’s disclosure that the release date for Yukon has slipped again gave some SQL Server users even more to think about than the potential effect on their IT project plans. Many Microsoft ...

InstantGMP categorizes software functions into low, moderate, and high process-risk groups. Low-risk features, such as equipment, room, deviation, and CAPA logs, primarily collect or tabulate data.

The "Computer System Validation (CSV) Training Course (Jan 27th - Jan 29th, 2026)" training has been added to ResearchAndMarkets.com's offering. A course designed to completely immerse you in computer ...