As life sciences, pharmaceutical, biotech, and medical device organizations accelerate digital transformation highlighted by the shift toward FDA Computer Software Assurance (CSA) draft guidance, ...
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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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 ...
ZenQMS and Sware provide Life Sciences organizations with a modern, risk-based approach to validating ZenQMS implementations and ongoing software releases ARDMORE, PA ...
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 ...
The US Food and Drug Administration’s (FDA) final guidance on software assurance in computer and data processing systems for medical device production includes more examples and a new section ...
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