Microlearning: GAMP® Basic Principles – Computer Software Assurance (CSA)

Overview

The "Computer Software Assurance (CSA)" section of the GAMP® Basic Principles (T45) training course introduces the FDA’s evolving guidance on CSA, emphasizing a risk-based, patient-centric, and quality-focused approach to software validation and assurance. Moving away from traditional documentation-heavy practices, CSA encourages critical thinking, defect prevention, and efficient assurance activities tailored to the software’s intended use and risk level. Participants explore key concepts such as high vs. not-high process risk, scripted and unscripted testing methods, and leveraging automation and supplier activities. The module also covers the importance of maintaining useful objective evidence, managing records appropriately, and applying CSA principles to support innovation and agility in regulated environments. Learners gain practical insights into how CSA supports modern development practices while maintaining compliance and enhancing product quality and patient safety.

• Earn 0.13 CEUs
• This course is self-paced. (Courses usually take 15 to 90 minutes to complete.)
• This course is part of the GAMP^® Basic Principles Bundle

Registration Fee

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For an enhanced learning experience, ISPE also offers these learning activities as live courses and gives you an opportunity to learn with a live instructor, ask questions, and participate in exercises. View upcoming courses