Applications used in clinical research must follow the rules found in CFR21 Part 11. Vestigo supports your 21CFR Part 11 compliance through an audit trail along with other data protection methods to ensure the integrity of the data captured. The audit log is presented in readable format and is automatically generated when data is changed. The audit log is time stamped along with the user executing the change.
To access the Audit Trail, click the View Audit Trail link on the Protocol Snapshot.
To generate a report, first enter the date range you are reviewing, select Search and then select Report. The audit trail has the ability to filter by source of the data, date range and whether the field is subject to 21CFR Part11.
Certain changes to the protocol such as what is found in the local information screen does not require audit logs per the regulation but Vestigo logs changes as a tool for users to see history.
Vestigo Verify Access
Vestigo Verify users will have access to the protocol audit log, but they will only be able to view edits that are marked as 21CFR Part 11. They will not be able to see any modifications made to things like workload or billing.