GAMP Guide: Records & Data Integrity

 

The Guide is intended to be a complete and comprehensive single point of reference covering the requirements, expectations, and principles of pharmaceutical data integrity. Topics covered include regulatory focus areas, the data governance framework, the data life cycle, culture and human factors, and the application of Quality Risk Management (QRM) to data integrity. As such, it is of great interest to anyone with a responsibility for ensuring data integrity.

Key benefits of the ISPE GAMP® Guide: Records and Data Integrity:

• Data integrity requirements, critical areas of regulatory focus and concern, and key concepts
• Framework for data governance and the importance of human factors
• Complete data life cycle approach as part of a Quality Management System (QMS), from creation to destruction
• Further information on how to apply the Quality Risk Management (QRM) approach from ISPE GAMP®5 to record and data integrity
• More detailed information, including “how to” guidance for specific topics, in a series of management, development, and operation appendices