Dublin, Jan. 07, 2026 (GLOBE NEWSWIRE) -- The "FDA's 21 CFR Part 11 Add-on Inspections (Jan 12, 2026)" training has been added to ResearchAndMarkets.com's offering. The verification and validation of ...

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, ...

Every time software that pharma, medical device and biotech companies use for development and manufacturing gets updated, the FDA requires it to be validated for data integrity, reliability, and ...

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 ...

Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...

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 ...

Validate it? I just want to use it! Sound familiar? Most companies in the medical device industry understand and accept the need to validate software that is critical to the functioning of a medical ...