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 ...

Providing an adequate level of IT assurance for legal industry leaders has become a high-profile challenge, as firms of all sizes find themselves on the front lines of the global ransomware war. Just ...

The U.S. FDA released a draft guidance for computer software assurance, a document that spells out the agency’s expectations for computer systems used to log a manufacturing site’s compliance and ...

DUBLIN--(BUSINESS WIRE)--The "The FDA Recently Released a New Draft Guidance Related to Part 11" webinar has been added to ResearchAndMarkets.com's offering. As part of the Case for Quality program US ...

The U.S. FDA issued a pair of final guidances this week, including one that outlines the criteria for authorizing emergency ...