Published: October 2018
In recent years significant problems with data integrity have been found in the pharmaceutical, biotechnology, and medical device industries worldwide. This ultimately affects patients, as patient safety is intrinsically impacted by the integrity and quality of the data on which a regulatory decision is based.
Additionally, the implementation of behavioral, procedural, and technical solutions to meet regulatory requirements throughout the business process proves to be challenging for organizations that do not have expertise in incorporating data integrity into their daily activities.
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.
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.