Today's article falls under the handy reference category. The ISPE GAMP Data Integrity Maturity Model provides a framework to evaluate and improve data integrity practices for Life Science companies. The following consolidates the information from the ISPE GAMP Guide: Records and Data Integrity appendix. This table combines the model, which is spread across multiple pages in the guide. The maturity levels are mapped to the various process and sub-process areas.
Each maturity level is designed to help organizations identify their current state and develop strategies for achieving compliance, efficiency, and data governance. The framework covers culture, governance, regulatory requirements, and data life cycle and is a comprehensive guide for ensuring data integrity.
International Society for Pharmaceutical Engineering. (n.d.). GAMP: Records and pharmaceutical data integrity. Retrieved December 31, 2024, from https://ispe.org/publications/guidance-documents/gamp-records-pharmaceutical-data-integrity