Data Integrity and Risk Management: A Modern Extension of GMP Principles

In its 2004 report “Pharmaceutical cGMPs for the 21st Century – A Risk-Based Approach”, the FDA highlighted risk management as a cornerstone of public health protection. The agency emphasized that efficient risk management requires the use of robust scientific data, quality standards, and consistent decision-making—principles that form the foundation of Data Integrity.

Quality risk management is central to implementing and maintaining Data Integrity. Risks must be categorized simply and consistently to enable rapid, reliable control. A systematic, holistic approach—including risk analysis, governance strategies, and master data management—ensures organizations can monitor data, systems, and processes throughout their lifecycle. Risks, measures, and classifications are maintained in a risk register, guiding effective and efficient oversight.

Hybrid records, combining paper and electronic systems, carry the highest risk due to synchronization challenges and second-person review requirements, making them a focal point for audits. Data Integrity is therefore a natural evolution of classical GMPs, aligning regulatory expectations with modern quality and safety standards.

13-10-2025