Veeva Safety supports creating transmissions to Agencies (Submissions) and Partners (Distributions) for the device constituents of combination products using the following Transmission types:

  • AS2 Gateway
  • Email Profile
  • Manual
  • System Gateway

Once enabled and configured, Vault creates assessments for the device constituents of combination products. When the Evaluate Reporting Obligations action runs on a Case, Vault evaluates these device assessments against any Individual Device Transmission (IDT) reporting rules. If such a rule passes, Vault generates a Transmission using the destination’s IDT Transmission Profile.

Create IDT Transmission Profiles

Create a Transmission Profile for an Agency or Partner and set its Individual Device Transmission field to Yes.

Add IDT Reporting Rules

To create ISCR Reporting Rules for IDTs for an Agency or Partner, create custom reporting rules in their Rule Set that include the IDT Reporting Rule Parameter.