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GAMP Microlearning: Requirements

GAMP® Microlearning: Requirements

ISPE has created mirolearning offerings based on the GAMP® Basic Principles (T45) training course.  This section focuses on Requirements. The "User 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 methodologies like Agile influence the requirements process.
165.00