Enable Excluding Attachments and Literature Documents

Learn how to configure your Vault to enable excluding literature references and attachments from E2B(R2) and E2B(R3) files.

About the Feature

Support for excluding attachments and literature documents was added to Vault Safety in 22R3. You can now configure these documents to exclude them from E2B(R3) files. For E2B(R2) files, these documents can only be excluded for the FDA.

See Generate a Regulatory Report for more information.

Update the Transmission Object Layouts

In the Admin area, go to Configuration > Objects > Transmission. Add the Literature Documents and Attachment Documents fields to the following layouts in the Details section:

  • Distribution Detail Page Layout
  • Submission Detail Page Layout

Update the Document Fields Default Values in the Transmission Object

Update the Default Values for the following Transmission fields:

  • Literature Documents
  • Attachment Documents
  1. In the Transmission object, go to the Fields tab.
  2. Select Attachment Documents and update the Default Value to Exclude.
  3. In the Transmission object, go to the Object Types tab.
  4. Select Literature Documents and update the Default Value to:

    if (
    and (
    destination__vr.api_name__v = 'fda__v',
    transmission_document_type__v = 'fda_e2br2__v'
    ),
    Picklist.e2b_document_inclusion__v.include__v,
    Picklist.e2b_document_inclusion__v.exclude__v
    )

Update the Case Distribution Actions Permission Set

Grant Edit permissions for the following Transmission object fields:

  • Literature Documents
  • Attachment Documents
  1. Go to Users & Groups > Permission Sets > Case Distribution Actions Permission Set > Objects tab.
  2. Select the Transmission object.
  3. Grant Edit permissions for Literature Documents and Attachment Documents.