Audit trail

A record of events related to an individual data element including the original information and any changes to the information used to reconstruct a series of related events that have occurred. It may be composed of manual or computerized records of events and information, or both. A critical feature for any LIMS.

The record of events, either individually, or in blocks of temporally connected changes, must be associated with an individual user (or if changes are created automatically by the system, this must be indicated) and an unambiguous record of the date and time the change occurred (e.g., by the use of a time zone or reference to GMT).