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 ...

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to validation by applying FDA's draft guidance for Computer Software Assurance (CSA) using an agile approach, ...

The certification that a computer is operating according to specification. It includes the observation of the hardware, software, connected instruments, as well as the practices trained staff employ ...

SALT LAKE CITY, Oct. 04, 2023 (GLOBE NEWSWIRE) -- Today, MasterControl, a leading provider of quality management and next generation manufacturing execution software, announced Validation on Demand is ...

With car companies adding more cameras, digital display screens, active safety systems and other technology to their vehicles with each passing year, they are starting to rely more and more on ...