In today's fast-moving world of vaccines, gene therapies and biotherapeutics, computerized systems play a critical role in the discovery, manufacture and delivery of potentially life-saving drugs.

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 ...

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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, Feb. 06, 2023 (GLOBE NEWSWIRE) -- The "Introduction to Computer System Validation" training has been added to ResearchAndMarkets.com's offering. Computer system validation has been regulated ...

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 ...

Market opportunities lie in modernizing software development and validation approaches, emphasizing agility and continuous validation to meet changing needs, while ensuring compliance with FDA ...