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GAMP Microlearning: Testing of GxP Computerized Systems

GAMP® Microlearning: Testing of GxP Computerized Systems

ISPE has created mirolearning offerings based on the GAMP® Basic Principles (T45) training course.  This section focuses on Testing. The "Testing of GxP Computerized Systems" section of the GAMP® Basic Principles (T45) training course provides a comprehensive overview of testing strategies across the system lifecycle, emphasizing defect detection, risk management, and fitness for intended use. Participants explore both traditional and modern testing approaches, including scripted, unscripted, exploratory, and automated testing, with guidance on selecting the most appropriate method based on system impact and risk. The section highlights the importance of traceability, critical thinking, and precision in test design and execution, while also addressing regulatory expectations from Annex 11 and the FDA’s CSA initiative. Learners gain practical insights into test planning, environment management, documentation standards, and the roles of subject matter experts, with examples tailored to different GAMP categories and development models (e.g., Agile, SaaS). The course equips professionals to implement efficient, compliant, and quality-focused testing practices.
165.00