As life sciences, pharmaceutical, biotech, and medical device organizations accelerate digital transformation highlighted by the shift toward FDA Computer Software Assurance (CSA) draft guidance, ...
Dublin, April 15, 2026 (GLOBE NEWSWIRE)-- The "Computer System Validation Training Boot Camp? (Apr 13th - Apr 15th, 2026)" training has been added to ResearchAndMarkets.com's offering. Advancements in ...
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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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 "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 ...
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 ...
In this webinar, you’ll learn about the importance of computer system validation (CSV), how frequently it should be performed, and the benefits it can have to help meet FDA regulations and quality ...
1.Why does FDA require validation of spreadsheets and databases? To put it simply, the purpose of validating any software or computerized system is to establish trust in the data or electronic record.
In life sciences, AI usually makes headlines for drug discovery, molecule design or clinical insights. Behind the scenes, though, the fastest and most repeatable wins are showing up in FDA-oriented ...
SANTA CLARA, Calif.--(BUSINESS WIRE)--ValGenesis Inc., the market leader in enterprise validation lifecycle management systems (VLMS), announced today that a major healthcare provider in the U.S., ...