Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with content, and download exclusive resources. Madelyn Olson discusses the evolution of ...

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, ...

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 ...

Every product has defects. Finding them as early in the development process as possible is definitely something to strive for. Building quality into software as it's being developed is far more ...

General Dynamics Chairman and CEO Phebe Novakovic told investors and analysts during an earnings call last week that the company’s efforts to obtain type certification on the Gulfstream G700 in ...

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 ...

Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "Master Validation Plan - The Unwritten Requirements" training has been added to ResearchAndMarkets.com's offering. FDA Warning Letters and recent ...

Medical devices have to be designed so that people can use them easily and reliably. Human factors considerations have gained increased attention since the release of FDA's guidance document, Medical ...