Synopsis
The ISPE GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records provides practical and pragmatic advice on areas such as regulated records, data flows, and risk management approaches, with particular focus on process control systems, manufacturing execution systems, and the interfaces and relationship between them. Additionally, system-specific examples of topics such as segregation of duties and critical validation activities to support data integrity are discussed. Included are "quick wins" - suggestions that can create considerable improvement in the integrity of manufacturing system data with only modest resources.
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