GAMP® Resources

The ISPE GAMP® Guide: Records and Data Integrity provides principles and practical guidance on meeting current expectations for the management of GxP regulated records and data, ensuring that they are complete, consistent, secure, accurate, and available throughout their life cycle.

This ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design supports organizations as they embrace and implement a holistic approach by leveraging data governance and knowledge management activities to drive continual improvement in data integrity. The Guide promotes a patient-centric mindset, focusing resources and management attention on quality best practices that inherently facilitate meeting regulatory compliance requirements.

This Guide provides guidance on how to integrate tools such as Cultural Excellence and critical thinking skills into data integrity practices which can help companies meet regulatory requirements and expectations. Numerous examples of good data integrity practices along with ways to identify risks and detect issues are included to assist organizations in developing or raising their data integrity awareness.

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.

The ISPE GAMP® Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach uses a complete lifecycle approach to the development and use of MES for regulated manufacturing as a collection or domain of manufacturing related functions that integrates business and process controls, information flow, and human interaction to facilitate the operation of an organization. It collects and integrates information and knowledge from many disciplines and sources into a single comprehensive guideline.

The GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems is a revision of the GAMP® Good Practice Guide: Validation of Process Control Systems. It provides guidance on and examples of the application of the principles and framework of GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems to a wide range of systems, from basic instruments to large, complex, distributed control systems.

The Second Edition includes comprehensive and up-to-date guidance on the risk-based development, implementation, validation, and maintenance of GxP regulated global information systems and is fully aligned with GAMP® 5. It reflects changes in typical system architecture since the First Edition and also covers Software as a Service (SaaS) and other cloud solutions.

The GAMP® Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems highlights the importance of the operation phase of the system lifecycle, when it is more likely that the return on investment will be achieved for the significant time and resources expended in implementing new computerized systems. The Guide will help regulated organizations create regulated computerized systems that are fit for intended use and compliant with applicable regulations and provides comprehensive guidance for maintaining control of regulated systems throughout their operational life.