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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
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 ...
Market opportunities lie in integrating modern technology and agile methodologies to enhance compliance with FDA regulations. Emphasis on cloud services, validation approaches, and maintaining data ...
The U.S. FDA released a draft guidance for computer software assurance, a document that spells out the agency’s expectations for computer systems used to log a manufacturing site’s compliance and ...
After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...
Microsoft Corp.’s disclosure that the release date for Yukon has slipped again gave some SQL Server users even more to think about than the potential effect on their IT project plans. Many Microsoft ...
ABERDEEN PROVING GROUND, Md. – The world of cybersecurity is an ever-changing one. New threats constantly appear which can attack software whether it’s in your home computer or on the Army’s tactical ...
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