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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
Dublin, April 29, 2026 (GLOBE NEWSWIRE)-- The "Computer System Validation Training Boot Camp? (Aug 4th - Aug 6th, 2026)" training has been added to ResearchAndMarkets.com's offering. Advancements in ...
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 ...
Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...
BioAnalysis launches BASIS 2.0, its next-gen GMP-compliant AUC software for gene therapy. Higher throughput, one-click workflows and full regulatory compliance. We built BASIS 2.0 to dramatically ...
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