Enable Unknown Formulation Product Selection

With the 25R3 release, Veeva Safety introduces support for unknown formulation Products, ensuring a standard method of handling cases with limited product information by enhancing data consistency and preventing the need for manual data workarounds.

Enabling this feature has the following downstream impacts to reporting:

• Transmission Profile matching for submission rules
• Cross reporting
• Expectedness evaluations for Clinical Trial Study Cases
• Reporting rule parameters
• FDA MedWatch 3500A generation data mapping
• E2B(R3) mapping

After you have enabled this feature, see the following articles for more information:

• Manage Products
• Auto-Code and Browse Products

Prerequisites

To enable this feature in your Vault, you must enable Substances.

Update Safety General Settings

To enable this feature in your Vault:

1. Navigate to Admin > Settings > Safety General Settings > Other Options.
2. Select Edit.
3. Select the Use Unknown Formulation Products checkbox.
4. Select Save.

Update Product Object Type Layouts

For all desired Product object type layouts in your Vault:

1. Copy the standard layout and ensure the new layout is active.
2. Set the copied layout as the default.
3. Delete any other existing custom layouts.