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 ...

MEDLEMSNYHET - FDA’s final guidance on Computer Software Assurance (CSA) for Production and Quality System Software marks a significant modernization of software validation practices.

This publication concerns approaches for establishing the overall instrumentation and control (I&C) architecture of a nuclear power plant. It describes the characteristics and content of general I&C ...

We knew it was coming, and now it’s close. By the end of 2024, the US Food and Drug Administration (FDA) is expected to formally make reviews by a single institutional review board (sIRB) the standard ...