With the 26R1 release, Veeva Safety enhances the Rule Engine to evaluate reporting requirements for each device constituent of a Case Product. This automation ensures that ICSR transmissions are generated accurately and without manual intervention reducing the risk of non-compliance.
Once you have enabled this feature, see Configure Individual Device Transmissions for more information.
Update Safety General Settings
To configure your Vault to create assessments for device constituents of combination products:
- Navigate to Admin > Settings > Safety General Settings.
- Select Edit.
- In the Auto-generate Assessments section, select the Enable Device Constituent Case Assessments checkbox.
- Select Save.
Update the Transmission Profile Layouts
Add the Individual Device Transmission field to the following Transmission Profile layouts:
- AS2 Gateway
- Email Profile
- Manual
- System Gateway