CHAPTER 2: How Did We Get Here? Check Access

Data integrity is not a new subject as the requirements are explicit and implicit in Good Manufacturing Practice, Good Laboratory Practice and Good Clinical Practice regulations, regardless of which regulation is used by an organisation. However, data integrity is the hottest topic now in the pharmaceutical and allied industries. It is a global issue that is not focused on any one country or region. Most of the issues are caused by poor data management practices that have changed little in the past 20–30 years in many organisations and regulated laboratories. Most people though tend to focus on the cases of falsification and fraud that are highlights of reading numerous FDA warning letters over the past 15 years. Reading these you may be forgiven for thinking that data integrity is a recent topic, it is not. This chapter will provide the historical background to the current regulatory emphasis on data integrity and data governance.