CARY, N.C., Dec. 16, 2025 /PRNewswire/ -- InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its ...

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, ...

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 ...

Document Control Systems Inc. (DCS), a Salt Lake City-based provider of integrated quality management software solutions, is offering a free white paper and downloadable presentation discussing ...

Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...

The FDA's software precertification program aims to take a new approach to regulation for a health technology space that's evolving at dizzying speed. It's meant to offer a voluntary pathway that can ...

FDA’s device center released an updated version of its software precertification “working model,” known as Pre-Cert, laying out new details on the program's intended recipients and how it will differ ...

The draft is a near total overhaul of the document finalized by FDA in 2005, with only short sections on topics such as software verification and the history of software revisions surviving unchanged.

PRINCETON, N.J.--(BUSINESS WIRE)--Certara®, the global model-informed drug development and decision support leader, today announced that the US Food and Drug Administration (FDA) has renewed its ...