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The fundamental tenet of GAMP 5 is that the effort, rigor, and documentation required for validation should be commensurate with the risk the system poses to patient safety, product quality, and data integrity.

The digitization of the life sciences sector has introduced complex challenges regarding regulatory compliance. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), mandate that computerized systems used in manufacturing, laboratory testing, and distribution must be validated to ensure they function as intended. Historically, validation efforts were often characterized by a "check-box" mentality, resulting in excessive documentation that added little value to product quality.

The GAMP guidelines are based on several key principles:

Modern GAMP guidance (and the Second Edition of GAMP 5) places a heavy emphasis on Data Integrity. Systems must be designed and validated to comply with the ALCOA+ principles: