Using Root Cause Analysis to Understand Behaviour and System Drivers In the increasingly complex landscape of pharmaceutical and biotech regulation, data integrity culture has emerged as a fundamental pillar for ensuring compliance with regulatory directives such as 21 CFR Part 11. Root cause analysis (RCA) can be an effective method to delve into the underlying behaviours and systemic drivers that affect data integrity within corporate and clinical environments. This article provides a comprehensive, step-by-step tutorial aimed at professionals in the pharmaceutical industry, clinical operations, regulatory affairs, and medical affairs. The focus is primarily on the U.S. FDA, with references to…