The Part 11 Toolkit records all data entry and changes to system data in your MS Access database. The Change History screen displays all data added, edited or deleted from a record, including the UserID for the person making the change and the date/time the change occurred.
The audit trail also records the addition or removal of an electronic signatures, plus the meaning of the electronic signature.
Audit trails are secure, computer-generated and time-stamped
Deleted records are retained on their own separate and secure audit trail
The audit trail can be customized to record most system functionality
The Part 11 Toolkit Audit trail is fully compliant with 21 CFR 11.10e