Audit trail—11​.10 (e)

"(e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying."

Reliability of records must still be maintained even though an audit trail may not be specifically required due to the FDA's enforcement discretion defined in the revised guidance. Procedures should be established that require documentation of the methods for ensuring reliable records, whether this includes an audit trail or not.