In the pharmaceutical sector, compliance with regulations is crucial for ensuring the safety, effectiveness, and quality of products. A critical aspect of this compliance involves data integrity, an essential element for pharmaceutical companies that must demonstrate adherence to guidelines and regulations set by regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). In this context, the Data Integrity Gap Assessment represents an indispensable tool for properly preparing for an FDA inspection. The Gap Assessment is a systematic process aimed at identifying and analyzing discrepancies between the current state of a system or process and the regulatory requirements or best practice standards. Specifically, in the case of data integrity, this assessment focuses on verifying the completeness, consistency, and accuracy of the data collected and managed by the company.