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, ...

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, ...

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 ...

Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.

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 ...

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 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.

SALT LAKE CITY--(BUSINESS WIRE)--MasterControl Inc., a leading global provider of software solutions that enable life science and other regulated companies to deliver life-improving products to more ...