Implementation and Management of Data Integrity

Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both.  To assure the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in current Good Manufacturing Practices (cGMP) for US Food and Drug Administration (FDA)-regulated industry. In recent years, FDA has increasingly observed violations involving data integrity during cGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, biologics and medical devices.  These data integrity-related cGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees.