Discover the latest updates in GAMP®5's 2nd Edition, designed to tackle modern technologies like AI and Cloud Computing. It emphasizes robust Computer System Validation (CSV) and aligning with FDA's ...

Thompson observed that FDA’s draft guidance is very focused on software validation and risk analysis as those terms are defined in the quality system regulations.

AI, ML, and LLMs present opportunities in the life sciences for improved efficiency and efficacy in drug development and software lifecycle. Key market opportunities include streamlining operations, ...

This FDA software validation Webinar/training will discuss how to self audit and ensure validation and software quality processes that will pass FDA inspection.

Computer software assurance (CSA), the FDA's new framework for computer system validation (CSV), is being heralded as a game-changer.

The FDA's draft recommendations pertain to device software functions – software in a medical device (SiMD) and software as a medical device (SaMD), most notably – and describe data that would be ...

BOSTON--(BUSINESS WIRE)--Sware, provider of the most complete software validation solution for innovative life sciences companies, today announced that it raised $6 million in Series B funding ...

Makers of dental equipment don’t typically show up on the U.S. FDA enforcement radar screen, but the introduction of biologics and software into routine dental practice has upped the regulatory stakes ...