Microlearning: GAMP® Basic Principles – Testing of GxP Computerized Systems

Overview

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 testing objective, and the nature of the component under test. The section highlights the importance of traceability, critical thinking, and subject-matter expertise in test design and execution and addresses regulatory expectations under 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.

• 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