CHAPTER 19: Quality Metrics for Data Integrity Check Access

Quality metrics are objective measures used by management and other interested parties to monitor the overall state of quality of a GXP organisation, activity or process or study conduct, as applicable. In the WHO and PIC/S guidance documents for quality metrics are also advocated for data integrity, e.g. Measures to assess the effective functioning of pharmaceutical quality system controls and of the performance, quality and safety of medicinal products and reliability of data. However, it is important that metrics or key performance indicators (KPIs) do not drive activities that are counter to a data integrity culture, e.g. managers performance is based on a low number of deviations and investigations. Similarly, aggressive laboratory turn-around times can influence analyst behaviour and compromise data integrity.