Data integrity has become a serious issue over the past few years and therefore is a core focus of many enterprises. The FDA published a Data Integrity Guidance Document outlining compliance with CGMP that addresses the role of data integrity for industry. The document is a result of the FDA increasingly observing violations involving data integrity during inspections. These violations have led to FDA warning letters, import alerts, and consent decrees. The guidance document answers integrity questions and strives to clarify what the FDA expects from businesses.