Validify has introduced an AI-powered validation platform designed to modernize computer software validation for pharmaceutical, biotechnology and ...

Beyond Installation, Operational, and Performance Qualifications: A Risk-Based Validation Framework for AI-Driven Software in ...

In this webinar, you’ll learn about the importance of computer system validation (CSV), how frequently it should be performed, and the benefits it can have to help meet FDA regulations and quality ...

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

Autonomous and automated systems are increasingly being used across domains. Yet, the distrust in their reliability is growing due to lack of transparency, which will reduce acceptance and slow down ...

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 ...