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 ...

Arbour Group, a member of the Oracle PartnerNetwork, announced that it is teaming with Oracle to provide a comprehensive solution to support FDA software validation requirements, including Part 11, ...

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 ...

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 ...

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's second attempt at a regulatory approach to clinical decision support software appears to be better received by the medical device industry, which lauded the agency for taking a risk-based ...

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 ...

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, ...

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 ...