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 ...

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

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 ...

Every time software that pharma, medical device and biotech companies use for development and manufacturing gets updated, the FDA requires it to be validated for data integrity, reliability, and ...

Epic has developed a tool called the AI Trust and Assurance Suite. This suite offers continuous validation of artificial intelligence solutions and has reporting dashboards that automatically update ...

GM has ordered a new stop sale for its midsize pickup trucks due to a software issue not related to any safety concerns.

This file type includes high-resolution graphics and schematics when applicable. Lauro Rizzatti, Verification Consultant Hardware emulation continues to prove itself as a handy tool for ...

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 ...

The rate of technological advancement is increasing faster than ever before. Although the demands for meeting aggressive time-to-market requirements and innovating at warp speed are not new, they are ...

A certification flight required to clear the grounding on the 737 MAX is awaiting software validation, with Boeing CEO Dave Calhoun anticipating a third quarter return to service, according to the ...