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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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 main market opportunities lie in adapting FDA-regulated computer system validation methods to align with GAMP®5 Second Edition and CSA, embracing innovative technologies like AI, ML, 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 ...

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 ...

FDA emphasizes data integrity in its inspections of computer systems within regulated industries, focusing on compliance and consumer safety. This press release covers best practices in system ...

DUBLIN--(BUSINESS WIRE)--The "Computer System Validation for Cloud and COTS Applications-Live Online Training" training has been added to ResearchAndMarkets.com's offering. Advancements in technology ...

Bryan Ennis is the CEO and cofounder of Sware, a regulatory technology company serving healthcare, life sciences and SaMD companies. “The measure of intelligence is the ability to change.” This famous ...

DUBLIN--(BUSINESS WIRE)--The "Digital Validation Demystified - GAMP® 5 2.0 and CSA Integration" training has been added to ResearchAndMarkets.com's offering. This course equips you with the tools, ...