Audit trail. The audit trail is a form of metadata that contains 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.
For example, in a paper record, an audit trail of a change would be documented via a single-line cross-out that allows the original entry to remain legible and documents the initials of the person making the change, the date of the change and the reason for the change, as required to substantiate and justify the change. In electronic records, secure, computer-generated, time-stamped audit trails should allow for reconstruction of the course of events relating to the creation, modification, and deletion of electronic data. Computer-generated audit trails should retain the original entry and document the user identification, the time/date stamp of the action, as well as the reason for the change, as required to substantiate and justify the action. Computer generated audit trails may include discrete event logs, history files, database queries or reports or other mechanisms that display events related to the computerized system, specific electronic records or specific data contained within the record.
Where computerized systems are used to capture, process, report or store raw data electronically, system design should always provide for the retention of full audit trails to show all changes to the data while retaining previous and original data. It should be possible to associate all changes to data with the persons making those changes, and
changes should be time stamped and a reason given. Users should not have the ability to amend or switch off the audit trail.
The relevance of data retained in audit trails should be considered by the company to permit robust data review/verification. The items included in audit trail should be those of relevance to permit reconstruction of the process or activity. It is not necessary for audit trail review to include every system activity (e.g. user log on/off, keystrokes etc.), and may be achieved by review of designed and validated system reports.
Audit trail review should be part of the routine data review/approval process, usually performed by the operational area which has generated the data (e.g. laboratory). There should be evidence available to confirm that review of the relevant audit trails have taken place. When designing a system for review of audit trails, this may be limited to those with GMP relevance (e.g. relating to data creation, processing, modification, and deletion etc). Audit trails may be
reviewed as a list of relevant data, or by a validated ‘exception reporting’ process. QA should also review a sample of relevant audit trails, raw data, and metadata as part of self-inspection to ensure ongoing compliance with the data governance policy/procedures.
If no audit trailed system exists a paper-based audit trail to demonstrate changes to data will be permitted until a fully audit trailed (integrated system or independent audit software using a validated interface) system becomes available. These hybrid systems are currently permitted, where they achieve equivalence to integrated audit trail described in Annex 11 of the GMP Guide. If such equivalence cannot be demonstrated, it is expected that facilities should upgrade to an audit trailed system by the end of 2017.
FDA recommends that audit trails that capture changes to critical data be reviewed with each record and before final approval of the record. Audit trails subject to regular review should include, but are not limited to, the following: the change history of finished product test results, changes to sample run sequences, changes to sample identification, and changes to critical process parameters.