InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its software development and validation practices ...

The guidance, posted online on November 4, intended to provide information regarding the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and ...

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.

Dublin, Oct. 28, 2025 (GLOBE NEWSWIRE) -- The "Biopharmaceutical Manufacturing Process Validation (Nov 17th - Nov 18th, 2025)" training has been added to ResearchAndMarkets.com's offering. This ...

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 ...

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 ...

(I would like to thank John Murray of FDA, Scott Thiel of Roche Diagnostics and Russ Gray of the Anson Group for their comments on a draft. The views expressed -- right or wrong -- are only the author ...

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 ...