Identifying And Preventing Common Data Integrity Issues

By David Jensen, Master Control

Current good manufacturing practices (CGMPs) are minimum requirements that companies must meet in developing health care-related products. Data integrity plays a key role in all areas of CGMP compliance, and the FDA expects all data to be reliable and accurate. According to the FDA guidance “Data Integrity and Compliance With Drug CGMP,” pharmaceutical manufacturing companies should implement meaningful and effective strategies for managing their data integrity risks based on their process understanding and knowledge management of technologies and business models.²

Regulatory guidelines regarding data integrity have been in place for many years. Still, during fiscal year 2018, the FDA issued 85 CGMP warning letters to drug manufacturers — 42 of which had data integrity components.³

Data Integrity Compliance

Data integrity is established by ensuring data is stored and managed properly in its original form. This is challenging due to evolving data management technologies, best practices, and regulatory guidelines. Nevertheless, taking steps to resolve data integrity issues is far more advantageous and cost effective than recovering from them. A good approach to achieving and maintaining data integrity compliance is to develop a practical data management strategy that involves employees, IT data management processes, and company policies.