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Protocol Audit Trail

Ensure 21 CFR Part 11 compliance with Vestigo's time-stamped, human-readable audit trails and customizable, role-based report filtering.

Applications used in clinical research must follow the rules found in CFR 21 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 during a Monitor Visit

  1. On the Vestigo Verify Homepage - My Visits Tab, click on View Protocols for an active visit
  2. Locate the protocol to review and click on View Protocol
    1. Depending on how the site setup the visit, Verify users may have multiple protocols on one visit.
  3. Click on the Audit Log tab

From here, users can adjust the Audit Log filters like Date or Section. Currently, the audit log cannot be exported to a downloadable report. If this is needed, please contact the IDS pharmacy.