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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
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 ...
Dublin, Oct. 28, 2025 (GLOBE NEWSWIRE) -- The "Computer System Validation (CSV) (Nov 4th - Nov 6th, 2025)" training has been added to ResearchAndMarkets.com's offering. Advancements in technology have ...
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Modernizing Biotech Compliance: Inside the Transformation of Enterprise Validation Systems
In the highly regulated world of life sciences, quality isn’t a box to check—it’s a business imperative. For global enterprises operating under the scrutiny of the FDA, EMA, and other regulatory ...
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