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Computer System Validation - The Validation Master Plan
The document discusses Computer System Validation (CSV) and the importance of ensuring that computer-based systems meet predefined requirements, particularly in regulated areas impacting public health and safety. It outlines the role of Good Automated Manufacturing Practice (GAMP) guidelines in the validation process for electronic systems, their lifecycle, and the necessity of training and documentation. Key components include validation policies, roles, validation procedures, and the establishment of a validated state to maintain compliance throughout the system's lifecycle.
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