The course presents opportunities to enhance validation of automated pipelines, ensuring data integrity and audit readiness amidst rapid changes. It equips teams with methods for digital validation ...
This course offers a strategic edge by refining cloud system classification through CSA principles, preventing compliance pitfalls and inefficiencies. It empowers teams to enhance validation precision ...
Embrace Computer Software Assurance (CSA) for modern life-sciences by focusing on meaningful evidence rather than burdensome documentation. This approach enhances efficiency, aligns with FDA ...
This training unlocks opportunities for companies to modernize GxP validation by shifting to Computer Software Assurance, ensuring data integrity and compliance with FDA regulations, and addressing ...
The SNS records neural activity from 60 channels across four brain regions—an order-of-magnitude increase over commercially ...
Johnson & Johnson has secured an expanded indication from FDA for its TRUFILL n‑BCA Liquid Embolic System for embolization of the middle meningeal artery for the treatment of symptomatic subacute and ...
InstantGMP categorizes software functions into low, moderate, and high process-risk groups. Low-risk features, such as equipment, room, deviation, and CAPA logs, primarily collect or tabulate data.
O. Rose Broderick reports on the health policies and technologies that govern people with disabilities’ lives. Before coming to STAT, she worked at WNYC’s Radiolab and Scientific American, and her ...
(RTTNews) - Integra LifeSciences (IART) announced that it has received U.S. FDA 510(k) clearance for its CUSA Clarity Ultrasonic Surgical Aspirator System, for use in cardiac surgery. This clearance ...
Dexcom has been hit by a major safety issue for an Android version of its G6 continuous glucose monitoring system app, leading the FDA to issue its most serious recall notice. A “software defect in ...
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