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, ...

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 ...

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 ...

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

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 ...