Learn how to configure your Vault to generate and submit individual case safety reports in the MFDS E2B(R3) format.

About the Feature

With the 24R3 release, Vault Safety supports generating MFDS E2B(R3) reports that are compliant with the Republic of Korea’s Ministry of Food and Drug Safety (MFDS). To support electronic report transmission, this feature also introduces an MFDS transmission profile.

After configuring this feature, see E2B Generation: MFDS E2B(R3) Mapping and Standard Agency ICSR Submissions for more information.

Prerequisite

To enable this feature in your Vault, you must contact Veeva Support.

Update the Localized Case Assessment Result Layout

Complete the following steps to add the Localized Assessment Result field to the Localized Case Assessment Result object layout:

  1. Navigate to Admin > Configuration > Objects > Localized Case Assessment Result > Layouts > Localized Case Assessment Result Detail Page Layout.
  2. In the Details section, add the Localized Assessment Result field.
  3. Select Save.