This course examines FDA’s requirement for data integrity (DI) program in the heavily regulated pharmaceutical industry. Data integrity is a key component in making informed decisions within any regulated organization as reliable data promotes good decisions. Unmanaged and inaccurate data will have consequences on a company’s quality output, state of compliance, the risk to patient safety, and ultimately, the company’s reputation. FDA expects that all data be reliable and accurate. Learners will to implement meaningful and effective strategies to manage their data integrity risks based on their process understanding and knowledge management of technologies and business models. This course focuses on principles of DI and how to manage DI issues and prevent recurrence.