This chapter reviews regulatory requirements for data integrity and their practical adherence. Data governance expectations are presented along with foundational principles for good documentation practices, appropriate training and education, monitoring compliance, and continuous improvement within a supportive quality culture. The data characteristics of ALCOA+ (attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available) promoted by U.S. FDA and other regulatory authorities are explained. Then, risk-based application of suitable controls is also discussed alongside various factors that might adversely impact data integrity such as factors influencing human error and system architecture considerations. Guidance is provided on how to handle data integrity issues including conducting investigations and appropriate reporting of human error and falsification incidents to regulatory authorities. This chapter concludes by outlining how to approach a corporate remediation program. Findings from various regulatory inspections are interspersed throughout the chapter to help illustrate what is expected from regulatory authorities.