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 ...
The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...
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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
As life sciences, pharmaceutical, biotech, and medical device organizations accelerate digital transformation highlighted by the shift toward FDA Computer Software Assurance (CSA) draft guidance, ...
Critical Manufacturing, a subsidiary of ASM Pacific Technology, and Dataworks, a provider of innovative software solutions and validation services to the life sciences sector, today announced a ...
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