Additional Capabilities > Windchill Quality Management Solutions > The Windchill Customer Experience Management Process > Regulatory Decisions and Reports > Creating or Updating a Vigilance Regulatory Report
  
Creating or Updating a Vigilance Regulatory Report
If you are assigned to the Regulatory Report Creator role, use the following procedure to fill out the Vigilance regulatory report. If the Vigilance regulatory report was previously saved, you can follow these steps to continue filling out the report at a later date.
1. On your Home page, click the Vigilance Report Creation task from the My Tasks table.
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• The Subject column lists the customer experience identification information.
• Instead of navigating to the task page, you can right-click the task in the My Tasks table and select Enter Report Details.
• At any time, you can click Save and continue working on the report later.
• Click Refresh Report to update the report with any information that might have changed elsewhere in the system (for example, patient, facility, or reporter).
2. On the task page, click Enter Report Creation Details.
3. In the Edit Vigilance Report window, under Report Information and sections 1-4, 5-8, and 9-12, add relevant information to the report.
◦ The Report Type field is required. All other fields are optional unless indicated by an asterisk.
◦ The system initially adds information to the report based on the manufacturer, healthcare facility, and patient in the Related Personnel and Locations table and the medical device in the Related Products table.
4. Click Next.
5. In the Other NCAs/EEAD Countries step, under Identify to what other NCAs this report was also sent, add the list of NCAs who should also receive the report.
a. Click the add icon at the top of the table.
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If you know the code or description of the NCA, you can use the quick search boxes at the bottom of the table instead of using the add icon.
b. Select the checkbox next to each NCA that applies. To select all NCAs listed, select the checkbox next to NCA Code.
c. Click OK to add the selected NCAs to the table.
6. If this is the final report, under For final report only. The medical device has been distributed to the following countries: Within EEA and Switzerland, select the countries where the device has been distributed.
a. Click the add icon at the top of the table.
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If you know the description of the EEAD country, you can use the quick search boxes at the bottom of the table instead of using the add icon.
b. Select the checkbox next to each country that applies. To select all countries listed, select the checkbox next to EEAD Country Code.
c. Click OK to add the selected NCAs to the table.
7. Click Next.
8. Use the Attachments table to associate any additional documents with the Vigilance regulatory report. The following table describes the available icons:
Icon
Description
Remove the selected attachment.
Add a local file attachment. Local file attachments are files that you upload from your local machine to Windchill.
Click Browse to select a file on your local machine. You can also drag and drop one or more files onto the action window to upload them as attachments.
For more information, see About Drag-and-Drop.
Add a URL attachment. URL attachments are hyperlinks to content stored on a website outside of Windchill. For example, this can be a wiki page or product help site.
Add an external storage attachment. External content attachments are items that cannot be attached as local files or URL links because they are physical objects or places. For example, this can be a three-dimensional item such as a product model or prototype, or highly sensitive data stored in a secure location. An externally stored content attachment describes the content and refers the user to its location.
9. Click Next to review the information in the Product Details step.
10. Click Finish to move the regulatory activity to the Approval workflow state.