Microlearning: GAMP® Basic Principles – Requirements

Overview

The "Requirements" section of the GAMP® Basic Principles (T45) training course emphasizes the foundational role of well-defined user requirements in the successful implementation and validation of GxP computerized systems. Participants learn how user requirements differ from functional and design specifications, and why they are critical for regulatory compliance, system development, and business alignment. The module covers best practices for requirements gathering, stakeholder involvement, prioritization techniques (e.g., MoSCoW), and the importance of clarity, traceability, and measurability. It also explores common pitfalls, the impact of poor requirements, and how modern approaches like Agile influence the requirements process.

• 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