Adopting a Risk-Based Lifecycle Approach to GxP Computerized Systems with ValGenesis VLMS 4.2 (with GAMP 5 E2 and CSA Perspectives)
As life sciences companies continue to digitize their processes, the need for digital tools to help them manage the intricacies of digitalization is increasing. This session will highlight how ISPE GAMP 5 (Second Edition) requirements are configured out of the box through the CSA-ready ValGenesis 4.2 system. Presenter Steve Thompson will discuss why the industry struggles with risk management, requirements management, and formalized testing.