CSV Through The Lens of CSA

This course guides the learner through the evolution of traditional, proscriptive CSV to the more efficient CSA. At the core of CSA is risk-benefit analysis, which focuses on the task of classifying systems based on their impact to patient safety and product quality in order to assess the necessary assurance effort. Learners will gain practical insight into scaling their validation activities, contrasting rigorous scripted testing for high-risk, custom systems against leveraged assurance for low-risk, commercial software. Because this course describes how resources are focused on critical quality elements, learners can ensure compliance is maintained, accelerated system deployment, and maximized business value.