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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

This course covers the key concepts of GxP computerised systems validation and compliance, including the key regulatory requirements and effective industry good practice based on GAMP®5. Computerised ...

DUBLIN--(BUSINESS WIRE)--The "Implementing CSA for GxP Systems - Transition, Documentation, and Post-Transition Challenges and Opportunities (Oct 16th - Oct 17th, 2025)" training has been added to ...

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 ...

BALTIMORE--(BUSINESS WIRE)--Sapio Sciences, the science-aware™ lab informatics platform, today announced that its unified platform for research and clinical informatics has been validated to comply ...