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 ...
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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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 ...
The Software Assurance Marketplace, the SWAMP, is an important resource for improving software development and software assurance activities. Developed with funding from the Department of Homeland ...
The Computer Software Assurance (CSA) industry is experiencing rapid digital transformation as organizations prioritize robust software validation and compliance. Growing regulatory mandates and the ...
After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...
Software quality assurance engineers and testers oversee the quality of a piece of software's development over its entire life cycle. Software quality assurance engineers and testers have an eye for ...
DUBLIN--(BUSINESS WIRE)--The "Computer System Validation (CSV) Training Course (Sept 23rd - Sept 25th, 2025)" training has been added to ResearchAndMarkets.com's offering. The attendee will learn ...