With the 25R3 release, Veeva Safety supports electronic medical device reporting to the FDA and for distribution to partners through the FDA eMDR XML format. This feature introduces the fields and objects required for compliant file generation and submission. In addition, Vault now includes tracking of manufacturer sites and manufacturer report numbers, which it exports to the FDA eMDR XML and the August 2024 version of the FDA MedWatch 3500A form.
After configuring this feature, see FDA eMDR Generation Data Mapping and Manage Organizations for more information.
Update the Organization Layout
Based on your business process, to all applicable Organization object layouts:
- Insert the Manufacturer Site related object section.
- Edit the default columns to include:
- Site Name
- Site Number
Update the Manufacturer Site Layout
To the Manufacturer Site object layout:
- Insert the Site Report Number related object section.
- Edit the default columns to include Site Report Number Status.
Update the Product Registration Layout
To the Product Registration object layout:
- Insert the Product-Manufacturer Site related object section.
- Edit the default columns to include:
- Manufacturer Site
- Product
- Product Registration
- Status
Update the Case Product Layout
Based on your business process, in the Product section of all applicable Case Product object layouts, add the following fields:
- Manufacturer Site
- FDA Reason for Device Non-Evaluation
- FDA Manufacturer Report Number