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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
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 ...
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 ...
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After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...
techtimes

Risk as the New Compass: Transforming Software Assurance Through Risk-Based Approach

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 ...
Computerworld

Delay raises questions about Software Assurance contracts

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 ...