Audit Trail

The term "Audit Trail" refers to an organized record of all changes and actions within a system or document. This logging ensures data integrity and traceability, which are critical for meeting regulatory standards. The audit trail helps to make it clear who made changes, when, and why, making it a vital tool for quality assurance. With the rise of digitalization, the concept has gained significance in relation to data security and integrity, and it is explicitly mentioned in regulations such as 21 CFR Part 11, ALCOA++, or EU GMP Annex 11.