Software selection, implementation, and ongoing maintenance are critical stages in the life cycle of biomedical software systems such as asset and calibration management platforms. Yet few industry resources provide detailed, practical guidance for managing these processes effectively.

One notable exception is ISPE’s GAMP 5: “A risk-based approach to compliant GxP computerized systems.” More than 400 pages, this guidance document is the most comprehensive resource available for regulated industries. Yet surprisingly, many system owners remain unaware of its depth and value.

Here, we explore GAMP 5’s background, structure, and major updates in the second edition; highlight its unique contributions; and reveal a “hidden gem” that can save regulated companies substantial validation effort.

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