Data integrity is increasingly an area of focus during regulatory inspections across the GXP world and has been the subject of several guidance documents from the FDA, MHRA, and PIC/S. Review of inspectional observations suggests the industry is still struggling to meet expectations on this topic. Fortunately, the guidance are similar, which makes compliance simpler. For data to have integrity they must be complete, consistent, and accurate throughout their lifecycle. The foundational principles are straightforward:

1. Data must be Accurate, Legible, Contemporaneous, Original, and Attributable as well as Complete, Consistent, Enduring, and Available (often referred to as ALCOA+),
2. Good data governance is essential to data integrity, as are a modern pharmaceutical quality system and a culture of quality,
3. A data integrity strategy will be based on a facility-specific risk assessment and customized to mitigate unacceptable risk and document acceptable risk.

While these guidance focus on data integrity in manufacturing and distribution processes, they also include statements that refer to laboratory or clinical processes and are clearly applicable to any data that may be included in a submission. While the FDA guidance is the only official document as of this post, I feel the PIC/S document offers a much clearer set of expectations and examples and would be useful when a facility is establishing a data governance structure and for inspection preparation.

Text Copyright © 2019 Katrina Rogers