Audit Trail in Pharma: A Review

Abstract

“Audit trail” (also known as audit log) management in the pharmaceutical industry has become an integral part of the quality system because of the current international regulatory demand associated with a pharmaceutical product. Regulators, industry, and standards-setting organizations have recognized the significance of an audit trail, as it is associated with data integrity problems. Industries need to rely more on a risk-based approach to the review of audit trails and establish more nimble and flexible standards to complement these efforts. Pharmaceutical audits by governing bodies issued warning letters to many companies, and they have recognized that quality needs to be built into systems and processes throughout the lifecycle of the product. The audit trails feature is a key source and helps manufacturers to minimize the risk, to maintain the reliability, and security of electronic data to recover lost data. The review study shares some insight into the anatomy of an audit trail, what are its benefits, its types, features, regulatory guidance that are associated with various regulatory agencies, the review of an audit trail, and how to best comply with the audit trail. This article reiterates an interpretation that an audit trail feature plays a vital role to assure compliance.