Published: May 2019
Manufacturing systems, with their link to the physical process, have an obvious impact on patient safety and product quality. Careful consideration of data integrity risks, alongside all other risk types, provides a more complete assessment of the GMP risks associated with the system. In addition, there has been an increase in recent years of data integrity citations relating to manufacturing data. This Guide addresses the expectations for data integrity in a GMP environment to aid companies in meeting regulatory requirements.
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.
This Guide is positioned under the ISPE GAMP® Guide: Records and Data Integrity and is aligned with ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems.