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Physical injury or damage to the health of people, or damage to property or the environment.
Publication Source: GAMP® Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures
Publication Date: 2005
(ICH Q9) Damage to health, including the damage that can occur from loss of product quality or availability.
Publication Source: GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems
Publication Date: 2008
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