Configuring Export Binder as Merged PDF (Regulatory Documents)

Regulatory Documents provides users with the ability to export all document renditions in a binder as a single merged PDF file. This allows users to easily generate a complete file to submit to authorities when registering new products and responding to customer requests for regulatory documents.

Configuration Overview

Configuring your Vault to export a binder as merged PDF involves the following steps:

  1. Configure binders
  2. Configure the Export Binder as Merged PDF action
  3. Configure user permissions

Configuring Binders

Ensure you complete the binder configuration so users can create binders. In Registration & Dossier Management Vaults, you can also configure Dossier Binders so users can export a merged PDF for Dossier Binders containing up to 100 documents.

Configuring the Export Binder as Merged PDF Action

You must configure the Export Binder as Merged PDF user action on the applicable document lifecycle states. To do this:

  1. Navigate to Admin > Configuration > Document Lifecycles > [Document Lifecycle] > States > [State] > User Actions.
  2. Click Edit.
  3. Click Add Action for an existing rule or Create Rule to add a new rule.
  4. Optional: Define conditions.
  5. In the Allow the following actions section, select Export Binder as Merged PDF.
  6. Enter an Action Label.
  7. Click Save.

When users run the action action, Vault creates a new instance of the Export Binder as Merged PDF Job. When the job completes, Vault:

  • Generates a ZIP file containing the generated PDF file containing all the documents the user has permission to view. Only the user that ran the action can access the ZIP file, which expires in 14 days. If the file expires, users must run the action to generate a new file.
  • Notifies the user that the merged PDF is ready for download.
  • Creates a system-managed File Download Results record, which includes details about when the file expires and can no longer be accessed, the binder on which the action ran, and the user that ran the action. Do not modify the File Download Results object layout.

Vault automatically terminates Export Binder as Merged PDF Job instances that do not initiate within 16 hours of users running the action.

Configuring User Permissions

You must ensure users have the appropriate read and create permissions to access the appropriate documents and binders in addition to the following permissions and document roles:

  • Assign the Security Profile: Application: Document: Download Rendition permission to include document renditions in a merged PDF.
  • Assign the View Document and View Content permissions to the appropriate document roles on the applicable lifecycle states to view and export document renditions in a binder.
  • If your Vault uses Atomic Security for Documents on lifecycle states, assign Export Binder as Merged PDF: Execute permission to the appropriate document roles on the applicable lifecycle states.

You can complete all the steps in this article with the standard System Administrator or Vault Owner security profile. If your Vault uses custom security profiles, your profile must grant the following permissions:

Type Permission Controls
Security Profile Admin: Configuration: Document Lifecycles: Edit Ability to modify document lifecycles.
Security Profile Admin: Security: Permission Sets: Edit Ability to modify permission sets for users.