Building the Foundational Assurance Strategy

Join us as we demonstrate how to establish a compliant, efficient, and risk-based Computer Software Assurance (CSA) program by redefining the foundational Master Validation Plan (MVP) into a documented Assurance Strategy. As we work with scenarios from the world of computer system validation, you’ll discover how to adapt your Quality System procedures to strategically define scope, governance, and competency, ensuring your teams focus on quality over paperwork. You will learn how to apply the risk matrix by evaluating functions for their severity and likelihood of escape, allowing you to justify the selection of right-sized assurance activities and, ultimately, help your organization to make better use of resources and time during assurance activities.