Vault lets you export a dossier for each submission and select specific components within the eCTD structure, if needed. Because the export maintains the same folder structure used during import, you can use this option to leverage exported submissions or components for other regions. Exporting can also simplify the process of distributing dossiers with local affiliates or publishing partners.

If you need to export all the submissions for an application, see Using Bulk Submission Export.

How to Export

To export a submission dossier:

  1. Navigate to the Submission record in Admin > Business Admin or a custom tab.
  2. Choose Export from the Actions menu.
  3. From the Refine Selection page, review the structure of components. Select Export entire submission archive to include all components, or use the checkboxes to select specific components or subsections.
  4. Click Next.
  5. From the Confirmation page, review the summary. Click Finish to begin exporting.
  6. Vault sends a notification when the process is complete. Click the included link to download a ZIP file.

Exporting Large Submissions

If submissions exceed Vault export limits and you have the correct permissions, you can choose to export the submissions to the FTP rather than reducing your export size. To access the FTP, see Accessing Your Vault’s FTP Server.

You can find all exported content in the Submissions Archive Export folder, within your personal user folder on the FTP server. The folder structure and folders match those used during submission import. From here, you can download the export at your convenience. Your export also includes a Manifest log file, an Export Summary file, correspondence documents (if enabled), and a failure log file.

You must have a security profile with both the RIM Submissions Archive: Export and FTP Server: Staging permissions to export large submissions to the FTP.

Limits

Vault places some limits on exports:

  • Exports cannot include more than 50,000 files.
  • The total export cannot exceed 5.3GB (5368709120 bytes).

In some situations, Veeva can increase these limits to meet your organization’s needs. Contact Veeva Support.

The following permissions control your options for exporting an archive:

Type Permission Controls
User License Type Full User Ability to access the Export action on a Submission record
Security Profile RIM Submissions Archive: Export Ability to access the Export action on a Submission record; by default, this permission is only granted to users with the standard System Administrator or Vault Owner security profiles.
Security Profile File Staging: Access Ability to connect to the file staging server and download files extracted during a submission export (document source files and renditions); this permission does not grant the ability to upload files to the server or view directories created by other users.
Security Profile Tabs: Viewer: View Ability to access the Viewer tab.
Object Sharing Settings Viewer Ability to view the Submission record if Custom Sharing Rules are enabled for the object.
Document Role View Document (On archive binder) Ability to access the archive binder.
Document Role Download Source (On documents in the archive) Ability to download the source file for a given document via export.