CSA: Applying a Risk-Benefit Approach

Step into the role of a validation expert to apply your understanding of the principles of Computer Software Assurance (CSA). We’ll begin with an introduction and review of the shift in GxP system validation through a regulatory challenge of assuring a new, cloud-based system to demonstrate the critical flaw of over-validation (full scripting low-risk systems) and the dangers of under-validation (the quick-fix). Using a risk-benefit methodology, you’ll make the decisive choice that ensures compliance, maximizes efficiency, and defends system quality.

During this course, you will master the core of CSA: the Risk-Proportionality Rule and how to perform essential steps, including Risk assessment and Benefit Analysis. Through two detailed, interactive scenarios, you will learn when to mandate formal, scripted testing and when to use efficient, compliant methods, such as exploratory testing and leveraging vendor evidence. The outcome will be a stronger appreciation for the strategies that allow for faster technology deployment without compromising the imperative regulatory standards.