For purposes of this guidance, audit trail means a secure, computer-generated,
time-stamped electronic record that allows for reconstruction of the course of
events relating to the creation, modification, or deletion of an electronic record.
An audit trail is a chronology of the “who, what, when, and why” of a record. For
example, the audit trail for a high performance liquid chromatography (HPLC)
run could include the user name, date/time of the run, the integration parameters
used, and details of a reprocessing, if any, including change justification for the
Electronic audit trails include those that track creation, modification, or deletion
of data (such as processing parameters and results) and those that track actions at
the record or system level (such as attempts to access the system or rename or
delete a file).