When approving documents, a new interface can be used for a cleaner and more friendly experience that provides more workflow details to the user. For example, task details, activity title, and previous workflow activities, comments, and actions can be seen on the same screen. Alternatively, the old interface can still be used but it has been deprecated and will be removed from the product in the future.
Documents are approved, not approved, or postponed approval from the My Tasks list.
To approve documents (New interface)
- Go to Reviews and Approvals > My Tasks for the FDA or web client or click My Tasks from the mobile web client and select a workflow where the task is set to Approve.
- In the FDA, web client, and mobile web client, select the task from the list and click one of the action buttons on the task bar. Alternatively, right-click on a task and select Submit Approval. Or, click the action links in the email notification.
Approve – The document(s) status changes to “Approved”.
Do Not Approve – The document status changes to “Not Approved” and the workflow is terminated.
Postpone Approval – The document status changes to “Approval Postponed” and the workflow is terminated. This option is available only if it has been enabled on the workflow template. A window may appear where you are able to restart the workflow from a previous activity, add a one-time review activity, or return back to the initiator. Select the option to restart from the list, if presented, and click .
- In the Submit approval screen, the following information is displayed:
| Area | Description |
|---|---|
| Workflow name | The name of the workflow. This may be configured by custom naming. |
| Alerts area | Special alerts such as previous participant comments, overdue, restarted, reservations, on-behalf of are displayed on a colored background.
These alerts can be closed by clicking X in the message. |
| Task instructions with activity title | The activity title is taken from the activity title in the workflow template. |
| Approve x documents with x supporting documents | Number of main and supporting documents to be approved. |
| Task instructions area | Task instructions specified in the workflow template. The instructions should be reviewed prior to completing the task. |
| <action buttons> |
|
| Task details area |
|
| Workflow history area | Displays the history of the workflow. Click Changes to view the changes to the workflow.
|
or if the task is reserved, it may be unreserved 
System changes to the workflow such as adding main or supporting documents, adding one-time reviews, and delegating workflow tasks. Click the Changes link to view.
Workflow has been restarted
Reviewed or one-time review
Send for external signature
Workflow initiated- Select one of the following options:
- Approve – The document(s) status changes to “Approved”.
- Do Not Approve – The document status changes to “Not Approved” and the workflow is terminated.
- Postpone Approval – The document status changes to “Approval Postponed” and the workflow is terminated. This option is available only if it has been enabled on the workflow template. A window may appear where you are able to restart the workflow from a previous activity, add a one-time review activity, or return back to the initiator. Select the option to restart from in the list, if presented, and click .
- In the Complete approval submission area, enter a comment in the comment area. The text box size is adjustable.
- Click to add a feedback document. Browse for a file and click .
- To remove the local copy of the feedback document on the FDA, click Delete
. - If required, provide the requested supplemental authentication.
- Click Approve or Do Not Approve , depending on your previous selection.
- For Postpone approval submissions, you may be able to restart the workflow from a previous activity, add a one-time review activity, or return back to the initiator. Select an option and click Postpone approval . See Postpone Approval for more information.
- Alternatively, click Cancel
to return to the previous screen.
