Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with content, and download exclusive resources. Dany Lepage discusses the architectural ...

The main market opportunities involve providing training and solutions for regulatory compliance and V&V best practices in regulated industries. This includes developing Master Validation Plans, ...

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

Organizations must adapt to technological advancements by rethinking business models and embracing new software development methodologies like agile and waterfall. Exploring COTS, SaaS, IaaS, PaaS, ...

Validating requirements is a crucial step in software development, helping ensure the final product matches user needs and avoids costly rework. By combining methods such as prototyping, reviews, and ...

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, ...

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 ...

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 ...