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, ...

On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

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 ...

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 ...

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 ...

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 ...

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 ...

SOMERSET, N.J.--(BUSINESS WIRE)--LabVantage Solutions, Inc., the leading provider of laboratory informatics solutions and services including purpose-built LIMS solutions that allow labs to go live ...