Importing and Updating a FDA UDIs from a Spreadsheet
Importing Submissions from a Spreadsheet
Follow these steps to import a new FDA UDI submission from a spreadsheet into Windchill.
You can download
a sample spreadsheet from ptc.com and use it to create a UDI submission. For more information on creating UDIs, see
Creating a New UDI.
1. From your UDI library context, click Folders or Details.
2. From the Actions menu, select Import from Spreadsheet.
3. In the Import from Spreadsheet window, in the File Name field, click Browse.
4. Navigate to your spreadsheet and then click Open. The file name appears in the File Name field.
5. From the Import Action list, select one of the following:
◦ ADD ONLY—Select this option to create FDA UDI submission from a spreadsheet.
◦ ADD AND UPDATE—Select this option if you are not sure if the FDA UDI submission exists in Windchill. If the FDA UDI submission already exists, then it is updated with the new information from the spreadsheet. If the FDA UDI submission does not exist, then it is created.
6. Click Next.
◦ If messages appear in the
Errors and Warnings table in the
Validation step, correct the errors by editing and saving the spreadsheet. Click the revalidate spreadsheet icon
to update the table.
◦ If there are no errors or warnings, click Import.
Imported UDIs appear under Folder Contents in the Creation state. In the My Tasks table, the system creates a UDI Submission Creation task for each line of the spreadsheet.
7. To update the FDA UDI information, right-click the
UDI Submission Creation task and select
Edit UDI. Complete the information in the
Edit UDI window. For more information, see
Completing the FDA UDI Submission Form.
8. Click Finish to move the FDA UDI submission to the approval step.
| The UDI Super Set does not support import from spreadsheet. |
Updating FDA Submissions from a Spreadsheet
Follow these steps to update existing UDIs that were created from a spreadsheet in Windchill.
| Existing UDIs cannot be updated in the In Progress, Delayed, or Submission states. UDIs in the Closed state are iterated and updated, and then the system sets the state to Creation. If the correct information is present in the spreadsheet, the system updates the part details, linked parts, related objects, and UDI data. |
1. From your UDI library context, click Folders or Details.
2. From the Actions menu, select Import from Spreadsheet.
3. In the Import from Spreadsheet window, in the Local File Path field, click Browse.
4. Navigate to your spreadsheet and then click Open. The file name appears in the File Name field.
5. From the Import Action list, select one of the following:
◦ ADD AND UPDATE—Select this option if you are not sure if the FDA UDI submission exists in Windchill. If the FDA UDI submission already exists, then it is updated with the new information from the spreadsheet. If the FDA UDI submission does not exist, then it is created.
◦ UPDATE ONLY—Select this option to update an existing FDA UDI submission with information from the spreadsheet.
◦ UPDATE CHECKED OUT OBJECTS— Select this option to update the checked-out FDA UDI submission with information from the spreadsheet.
6. Click Next.
◦ If messages appear in the
Errors and Warnings table in the
Validation step, correct the errors by editing and saving the spreadsheet. Click the revalidate spreadsheet icon
to update the table.
◦ If there are no errors or warnings, click Import.
Imported FDA UDI submissions appear under Folder Contents in the Creation state.
7. To update the FDA UDI information, right-click the
UDI Submission Creation task and select
Edit UDI. Complete the information in the
Edit UDI Details window. For more information, see
Completing the FDA UDI Submission Form.
8. Click Finish to move the UDI to the approval step.
Completing the Spreadsheet
Complete the following tabs in the spreadsheet with the information you want to import into Windchill.
• UDI Submission Data
• Alternate Identifiers
• Device Contact Information
• FDA Product Code
• GMDN Term Code
• Premarket Authorization Number
• FDA Listing Number
• Sterilization Method
• Device Size Characteristics
• Storage and Handling Requirements
• Packaging Configuration
The fields in each tab correspond to entries in the UDI submission form. For additional instructions to complete specific fields, see
Completing the FDA UDI Submission Form.
The following fields appear in each tab of the spreadsheet:
• UDI Submission Name—The name of the FDA UDI submission. This is a mandatory field in each tab.
• Context of UDI Submission—If you do not specify this information, the system searches for the submission name in the context where the import action is performed.
• UDI Submission Type—This allows the system to have a FDA UDI submission with the same name but a different type. If you do not specify the type of FDA UDI submission, the default is FDA UDI Submission.
| • If you are completing the Sterilization Method tab, Sterilization Code is a mandatory field. • If you are completing the FDA Product Code tab, Product Code is a mandatory field. |
