CHAPTER 22: How to Conduct a Data Integrity Investigation Check Access

One of the Quality Assurance tasks in the current regulatory environment is to conduct data integrity investigations. The trigger for a DI investigation would occur when a data integrity violation has been identified and it aims to document the extent of the problem, the impact of it, the root causes and the corrective and preventative action plans. Following the presentation and examination of the regulatory guidance on the subject, two case studies are presented to outline the process and how to conduct and report a data integrity investigation. It is important to understand that data integrity investigations are not only due to human actions but also to technology issues. Therefore, the case studies described in this chapter cover both situations.