Create, Export, and Lock a Binder

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Managers

Note: This work instruction is intended to be used when you are using a third party for publishing, rather than Veeva RIM Basics: Submissions Publishing.

Once all content plan items are Complete and version-locked, you can create a binder from the content plan that can be published outside of Vault. You can create a binder of an entire content plan or only a specific section of the content plan. Once you have created a binder, you can export the binder, which creates a ZIP file with PDFs of each document in the binder.

Create a Binder from a Content Plan

Complete the following steps to create a binder from a content plan:

  1. From the content plan Actions menu, select Create Binder from Content Plan. A message is displayed to indicate that the binder is being created.
  2. Once you receive a notification that the binder has been created, click the Notifications bell icon to open the notifications panel.
  3. Click the Binder Name link in the notification to view the binder in the Submissions tab in the Submission Mgmt tab collection.

Export a Binder

Complete the following steps to export binder contents to a ZIP file:

  1. Open the binder you want to export.
  2. From the All Actions menu, select Export Binder. The Refine Selection page is displayed.
  3. To export all binder contents, select the Export entire binder checkbox.
  4. To export individual sections or documents, click Expand all and select the checkboxes for the sections and documents you want to export.
  5. Click Next. The Choose Artifacts and Naming Rule page is displayed.
  6. Select any of the following options as needed:
    • Select the Renditions checkbox if you want to export the renditions and select the type of renditions to export.
    • Select the Source Documents checkbox if you want to export the source files of the documents, for example, CSV or DOCX.
    • Select the Document Fields checkbox if you want to export a CSV file in the top-level binder folder listing each downloaded file and the associated document fields.
    • Select the Document Attachment checkbox if you want to export attachments that exist on the selected documents and select the version type you want to export.
    • Select the Document Audit Trails checkbox if you want to export the audit trails for the selected documents and then select the file type you want to export.
    • Select the document field from the Document Naming Rule drop-down that you want to use to name the exported document files.
    • Select the Version Selection option to determine which version of the selected documents to export.
  7. Click Next. The Confirmation page is displayed.
  8. Review the export rules summary. If you need to edit any of the information, click Back and update the information as needed.
  9. Click Finish. A message is displayed to indicate that the binder is being exported.
  10. Once you receive a notification that the binder has been exported, click the Notifications bell icon to open the notifications panel.
  11. Click Show More in the notification and click the ZIP file link to download the exported file to your selected download location.
We recommend creating one (1) folder in your storage location for each application, and storing each submission’s ZIP file and unzipped contents in a submission folder inside the application folder. This folder structure helps ensure that all submissions for an application are in a central location, which makes it easier to locate the appropriate submission folder when sending a submission to your third-party publishing tool and when importing a submission in Veeva RIM Basics: Submissions Archive.

Update a Binder with New Content

If updated documentation is available and you want to update your binder with the new content, you must add the updated documentation to the content plan, re-create the binder using the updated content plan, and then export the updated binder. When you re-create a binder, Vault updates the binder version to the next minor version.

Lock a Binder & Finalize the Content Plan

After publishing and submitting an exported binder to the authorities, lock the binder by changing its status to Approved so that its contents are reflective of what was entered into your third-party publishing tool. Then, change the content plan’s status to Final to finalize the content plan contents used to create the binder that was published and submitted to the authorities.

Complete the following steps to update the binder and content plan statuses after submission to authorities:

  1. Open the binder you want to lock and approve.
  2. From the Workflow Actions menu, select Direct Approval. Vault changes the binder status to Approved, locks the binder from editing, and updates the version to the next major version.
  3. Open the content plan you want to finalize.
  4. From the content plan Actions menu, select Change State to Final. Vault changes the content plan status to Approved and locks the content plan from editing.