This Guide is intended to encourage organizations to adopt a risk-based approach to ensuring data integrity insupport of patient safety and product quality.

The scope of this Guide is as broad as the scope of ISPE GAMP® 5 [9] and includes all computerized systems used in support of GxP regulated business processes within the life science industries. While computerized systems feature strongly within this Guide, as these systems provide technical controls for data integrity, data governance also requires procedural and behavioral controls supported by a quality culture that leverages critical thinking and a continual improvement mindset.

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