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.

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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

Integrating Git version control with validation systems automates medical device software traceability, ensuring instant ...

Today’s complexity of embedded systems is steadily increasing. The growing number of components in a system and the increased communication and synchronization of all components requires reliable ...