Approving Multiple UDIs
Many customers have product lines with similar products. After UDI objects are in the Approval state, users can approve several UDIs at once, instead of manually approving each submission.
Follow these steps to approve multiple UDIs that are similar.
1. In your UDI library context, click UDIs to Approve.
2. In the UDIs to Approve table drop-down menu:
◦ select FDA UDI Submissions to display all the FDA UDIs to be approved.
◦ select UDI Super Set to display the UDI Super Sets to be approved.
3. After selecting UDIs, click approve UDIs
. The
UDIs to Approve window appears with the following information in the
UDIs table:
◦ Common Attributes—This section contains the fields that are common across all selected UDIs.
◦ Approvals—This section contains the fields that are unique to a UDI. If a UDI has no value for a specific field (the field is blank), and the field is listed as a common attribute with a value, the field is shown with a strikethrough.
4. In the UDIs to Approve window, do the following:
| • Comments and Routing Options are applied to all selected UDIs. • To view a PDF version of the report, click the view report icon next to each item. • The UDIs to Approve window can include attributes from the Type and Attribute Management utility in Windchill. Because of this, you might see additional attributes that are not reflected in the printed report. The printed report only contains the information sent to the regulatory agency that requested the UDIs. |
a. Under UDIs table, select the items to approve.
b. In the Comments field, enter your comments if applicable.
c. Under Routing Options, do one of the following:
▪ To approve the UDIs, click Approve. This moves the UDIs to the next state.
▪ To reject the UDIs, click Reject. This moves the UDIs back to the UDI Creation state.
d. In the Password field, type your password.
e. Click Finish.