Glossary Term
Audit Trail
Definition
An Audit Trail is a chronological record of all changes, actions, or events associated with a system, process, or document. In the MedTech industry, audit trails are critical for maintaining transparency, accountability, and compliance by providing an accurate, tamper-proof history of activities such as data entry, system modifications, or device manufacturing steps.
Relevance to the MedTech Industry
Audit Trails ensure traceability and integrity in critical processes such as clinical trials, quality management, and regulatory compliance. They help manufacturers and healthcare providers identify and address discrepancies, maintain data security, and meet requirements from regulators like the FDA or EMA.
Additional Information & Related Terms
21 CFR Part 11 Governs the integrity of electronic records and audit trails in regulated environments.
Good Manufacturing Practices (GMP) Requires detailed documentation, including audit trails, to ensure compliance.
Traceability Ensures all steps in the device lifecycle are documented and traceable through audit trails.
Post-Market Surveillance Uses audit trails to investigate and address issues in device performance.