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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
Integrating Git version control with validation systems automates medical device software traceability, ensuring instant ...
Computer system validation, popularly known as CSV is the process of procuring documented evidence that ensures the consistent performance of a computerised system as required by the operational ...
Dublin, Dec. 01, 2021 (GLOBE NEWSWIRE) -- Less than two weeks to register for the "Computer System Validation (CSV) Training" training course has been added to ResearchAndMarkets.com's offering. This ...
This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation ...
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 ...
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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