Audit Trail

Audit Trail

UK: MHRA Guidance on GxP Data Integrity – The audit trail is a form of metadata containing information associated with actions that relate to the creation, modification or deletion of GXP records. An audit trail provides for secure recording of life-cycle details such as creation, additions, deletions or alterations of information in a record, either paper or electronic, without obscuring or overwriting the original record. An audit trail facilitates the reconstruction of the history of such events relating to the record regardless of its medium, including the “who, what, when and why” of the action (as per Section 6.13 of MHRA – Guidance on GxP data integrity, March 2018).