Additional Windchill Capabilities > Windchill Quality Solutions > The Windchill Customer Experience Management Process > Regulatory Decisions and Reports > eMDR Process Overview > Creating or Updating an eMDR
Creating or Updating an eMDR
If you are assigned to the Regulatory Report Creator role, use the following procedure to fill out the eMDR. If the eMDR was previously saved, you can follow these same steps to continue filling out the report.
1. On your Home page, click the eMDR Creation task from the My Tasks table.
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).
Click Blank Values to change the meaning of each blank field. For more information on setting up defaults for blank values, see Configuring eMDR Blank Values.
2. On the task page, click Enter Report Creation Details.
3. In the Edit eMDR window, add relevant information to the report.
All fields are optional unless indicated by an asterisk. The following fields are required:
Name—The eMDR name. The system automatically completes this field, but you can change it manually if necessary.
Describe Event or Problem—A description of the event or problem.
Common Device Name—The common name of the device.
FDA Product Code—The product code assigned by the FDA. Enter the code and select from the pop-up that appears when you begin typing, or click the find icon to search for product codes.
The system initially adds information to the report based on the manufacturer and complainant in the Related Personnel and Locations table and the medical device in the Related Products table.
4. Click Next.
5. Under Codes, click the add row icon to add therapy dates, patient codes, device codes, method codes, result codes, and conclusion codes.
If you know the code or description, you can use the quick search boxes at the bottom of most tables instead of using the add row icon.
6. Click Next.
7. Use the Attachments table to associate any additional documents with the eMDR. The following table describes the available icons:
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.
8. Click Next to review the information in the Product Details step.
9. Click Finish to move the regulatory activity to the Approval workflow state.