GLP Data Integrity

This document provides guidance for test facilities or test sites that conduct GLP studies or GLP study phases. The guidance aims to promote a risk-based approach to the management of data that includes data risk, criticality and life cycle. Users of this document need to understand the data flows they are responsible for or involved in (as a life cycle) in order to identify data that are likely to have impact on GLP compliance. In turn, this will support the identification and the implementation of the most effective and efficient risk-based controls.