Enable Remedial Actions and Malfunction for Combination Products

Veeva Safety now supports data entry for remedial actions and malfunctions at the device-level, as well as device codes for Cases that involve multiple Combination Products or a Combination Product that has multiple device constituents. Vault exports Remedial Actions and Malfunctions on Case Products to FDA Medwatch 3500A, FDA E2B(R2), and FDA VAERS E2B(R3) formats.

For details on working with device-specific adverse event codes, see Enable the IMDRF Dictionary for Maintenance, Case Processing, and Submissions.

After configuring this feature, see more information about entering remedial actions and malfunctions at the Case Product level and the Case level.

Update Case Page Layout for Device Report Type (Status)

  1. Navigate to Admin > Configuration > Objects > Case > Layouts > Case Page Layout.
  2. In the Device Details section, complete the following setup:
    • Add the Device Report Type (Status) field.
    • Remove the Remedial Action and Remedial Action-Other fields.
  3. To rearrange the fields, drag and drop.
  4. Select Save.

Update Case Product Device Detail Page Layout for Remedial Action and Malfunction

  1. Navigate to Admin > Configuration > Objects > Case Product > Layouts > Device Detail Page Layout.
  2. In the Details section, complete the following setup:
    • Add the Malfunction field.
    • Add the Remedial Action field.
    • Add the Remedial Action Other field.
  3. To rearrange the fields, drag and drop.
  4. Select Save.