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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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