Registration & Dossier Management provides you with the ability to create and export a Dossier Binder for a specific requirement that includes a list of all expected documents needed for a submission. Vault organizes the documents in nested hierarchical sections that match the Requirement hierarchy structure.

Before creating a Dossier Binder, review the hierarchical structure and matched documents in the Requirement Hierarchy Viewer and make any necessary changes.

Depending on your Admin’s configuration, object, field, and section labels may appear differently than the labels mentioned in this article.

About Dossier Binder Creation

When configured by your Admin, Registration & Dossier Management includes an action on the Requirement object that lets you create a Dossier Binder based on all related Requirement child records, their related EDL Items, and applicable matched documents. Your Admin may also configure this action to run as part of a change to a Requirement’s lifecycle state.

When you trigger the Create Binder action on a Requirement record, Vault creates a Dossier Binder for that requirement and does the following:

  • Labels the binder with the same label as the parent record.
  • Populates the Binder field on all Requirements in the hierarchy.
  • Assigns a document type and lifecycle to the Dossier Binder based on your Admin’s configuration.
  • Creates a top-level parent section in the binder for the parent record.
  • Creates sections for each active Requirement record in the hierarchy with the Dossier Folder checkboxes selected based on their order in the Requirement Hierarchy Viewer. If no records in the hierarchy have the checkboxes selected, Vault creates the binder without subsections.
  • Adds matched documents according to related EDL Item records sorts them based on the order of their associated Requirement and then by document name.
  • Populates the Requirement field on all documents in the binder with the label of the parent record.

Vault executes the Create Binder action as the “System User” instead of the user who triggered the action.

How Vault Adds Documents to a Dossier Binder

Vault automatically adds matched documents to the relevant binder sections for every EDL Item related to each Requirement. Vault applies the following rules when adding documents:

  • Vault binds documents to locked steady state versions. If there are no locked versions, the documents are left unbound.
  • If there is no corresponding Requirement section because the Dossier Folder checkbox on the related Requirement is clear, the document is added to the next section up in the hierarchy.
  • If multiple EDL Items related to a Requirement contain the same document, Vault adds only a single instance of the document to the section.
  • If you have not related any EDL Item records to the Requirements in the hierarchy, Vault still creates the Dossier Binder but does not populate it with any documents.

Dossier Binders with Shared Requirements

If you generated Requirements with the Generate Requirements action after specifying a root Requirement in the Source Dossier field, Vault adds documents depending on if you customized any of the generated Requirements:

  • For any Requirement on which you ran the Customize action: Vault adds document versions matched to the shared source EDL Items related to the source Requirement.
  • For any Requirement on which you did not run the Customize action: Vault adds document versions matched to the EDL Items generated by the Customize action.

The Use Source checkbox is automatically selected on Requirements with shared requirements, excluding any Requirements on which you ran the “Customize. If you clear the Use Source checkbox, Vault will not include the shared documents in the Dossier Binder.

Creating a Dossier Binder

To create a Dossier Binder:

  1. Navigate to an active root Requirement record.
  2. Select the Dossier Folder checkboxes on the appropriate Requirement records in the related records hierarchy. Vault only creates binder sections for related child records with Dossier Folder checkboxes selected.
  3. Optional: Clear the Use Source checkbox for any Requirement that you do not want to reuse shared documents.
  4. From the All Actions menu, select the appropriate action depending on your business needs:
    • Create Binder to create a new binder. If you don’t see the Create Binder option in the All Actions menu, the action may be part of an entry action. See Automatic Dossier Binder Creation for more details.
    • Create and Export Binder to create and export a new binder. If binder creation fails, Vault does not prepare the binder for export.

When notified that the Dossier Binder creation completed successfully, you can view and edit your Dossier Binder as needed.

If you selected Create and Export Binder, Vault first creates the Dossier Binder, then exports the entire Dossier Binder with all documents in the folder structure that you have permission to download, with the following parameters:

  • Renditions: Viewable renditions
  • Version: Follows version binding rule

Up-Versioning a Dossier Binder

You can up-version an existing Dossier Binder to reflect any updates you’ve made to the Requirement related records hierarchy, including any changes to EDL Items. To do this, trigger the Create Binder action or Create and Export Binder action to recreate a Dossier Binder on the same parent Requirement record. When the action runs, Vault updates the Dossier Binder to the next applicable version number.

If you selected the Create and Export Binder action, Vault notifies you when the binder export is complete and provides a link to download the ZIP file of the up-versioned binder after creation. If binder creation fails, Vault does not prepare the binder for export.

Automatic Dossier Binder Creation

Depending on your Admin’s configuration, Vault may automatically create a Dossier Binder when a Requirement record enters a specific lifecycle state rather than, or in addition to, the Create Binder action being available to you in the All Actions menu.

Ensure that the Dossier Folder checkboxes are selected for the appropriate Requirements records in the related records hierarchy, then change the state of the record from the Workflow Actions menu to trigger the Create Binder action.

Exporting a Dossier Binder

You can export a previously-created Dossier Binder by executing the Export Dossier Binder action on an active Requirement record. To export a Dossier Binder:

  1. Navigate to an active Requirement record.
  2. From the All Actions menu, select the appropriate action depending on your business needs:
    • Export Binder to export a binder you have already created.
    • Create and Export Binder to create and export a new binder or to up-version and export an existing binder. If binder creation fails, Vault does not prepare the binder for export.

Vault exports the entire Dossier Binder with all documents in the folder structure that you have permission to download with the following parameters:

  • Renditions: Viewable renditions
  • Version: Follows version binding rule

If configured by your Admin, you can export a Dossier Binder with less than 100 documents as a single merged PDF file with the Regulatory Documents application.

Notifications

You’ll receive an email and a Vault notification letting you know if the Dossier Binder was created or exported successfully or if there were any errors. When you trigger binder creation, the notification also provides details if the Dossier Binder was created but does not contain any unlocked documents or if there are fewer or more matched documents than expected.

When you execute the Export Binder or Create and Export Binder actions, the email and notification include a link to download the ZIP file. The notification also includes the number of files processed and downloaded as well as any documents that failed to export. When you execute the Create and Export Binder action, Vault first notifies you when the binder is created and again when the binder export file is ready to download.

Limitations

In addition to the standard export size limits for all Vault binder exports, the following limitations apply to the Create Binder and Create and Export Binder actions:

  • Vault supports the following Requirement structures:
    • Up to 100,000 Requirements in a hierarchy.
    • Up to 100 root Requirements, with up to 1,000 child Requirements for each root.
    • Up to 2,000 matched expected documents for each root Requirement.
    • Up to ten (10) Requirement hierarchy levels.
  • The maximum number of sections Vault supports for a generated binder is 2,000.
  • Exported Dossier Binder ZIP files cannot exceed 5GB.