Users can see what they’ve been assigned, and various department users can contribute and collaborate on the product quality review (PQR). Users can send all approvals at once, receive email notifications and sign them, respond and make changes in real time.

When a PQR is initiated, assigned users are notified of tasks and can contribute to the PQR. The system then validates data to confirm that it is formatted properly for analysis. Approvers are assigned the report for review and approval or to return with comments.

Send PDF reports to all assigned approvers with a click of a button. Approvers can generate a final APQR ready for submission to the FDA.

Set up and receive notifications on assigned tasks and report status via email or on the app. PDF reports contain signatures that comply with 21 CFR Part 11.