Working with Commitments

As a condition of approving a product to be marketed or changed, a Health Authority may require changes to a Submission or require that additional information be provided in areas such as safety, efficacy, or optimal dosage. These required updates are referred to as regulatory commitments.

Vault RIM Basics allows you to create Commitment records to track the progress of your regulatory commitments, including tracking owners, due dates, statuses, and correspondence.

Creating Commitments

Complete the following steps to create a Commitment:

  1. Navigate to Submission Mgmt > Commitments and click Create. Vault opens the Create Commitment page.
  2. Enter the Commitment Name. 
  3. Select the Primary Product Family associated with the Commitment and select the Country of the associated Application. 
  4. Select the Related Application. The available applications are based on the Primary Product Family and Country you selected. 
  5. Optional: Enter the following optional information:
    1. Select the Functional Areas Impacted in relation to the Commitment.
    2. Select the Commitment Owner responsible for managing the Commitment response process.
    3. Select Yes for Reportable in Periodic Report if this Commitment information needs to be included in a periodic report. No is selected by default.
    4. If you selected United States for the Country, select the US Commitment Status. This is the status as defined by the FDA. 
    5. Enter the Commitment Due Date the Commitment is due to be completed.
    6. Enter any general Comments related to the Commitment.
    7. In the Commitment Text section, enter the Full Commitment Text.
  6. Click Save. Vault creates the Commitment record in the Open status.

Updating Commitment Statuses

Commitments use the following statuses:

  • Open: This status indicates that the Commitment has been created but work has not yet been started. 
  • Ongoing: This status indicates that work has started on the Commitment.
  • Closed: This status indicates that all tasks for the Commitment are completed and no further work is required.

To change the status of a Commitment, select the appropriate Change State action from the Workflow Actions menu. You can change an Open Commitment to Ongoing, an Ongoing Commitment to Closed, and a Closed Commitment back to Open.

Editing Commitments

Complete the following steps to edit a Commitment:

  1. Open the Commitment you want to edit.
  2. Click Edit () on the action bar.
  3. Update the Commitment information as needed. 
  4. Click Save to save the changes.

Adding Correspondence to Commitments

When adding correspondence documents to a Commitment, the documents must use the same Primary Product Family as the Commitment.

Complete the following steps to add correspondence documents to a Commitment:

  1. Open the Commitment you want to add correspondence documents to.
  2. Expand the Correspondence section of the Commitment and click Add. Vault displays the Search: Documents dialog with a list of documents where the document Subtype is Correspondence.
  3. Add the correspondence documents using one of the following methods:
    • Select one or more correspondence documents in the Search: Documents dialog and click Close. Vault adds the selected correspondence documents to the Commitment.
    • Click Create in the Search: Documents dialog to upload a new correspondence document, enter the appropriate document information, and click Save. Vault adds the uploaded correspondence document to the Commitment.

Removing Correspondence from Commitments

Complete the following steps to add correspondence documents to a Commitment:

  1. Open the Commitment you want to remove correspondence documents from.
  2. Expand the Correspondence section of the Commitment and click Add. Vault displays the Search: Documents dialog with a list of documents where the document Subtype is Correspondence, including documents that have been added to the Commitment.
  3. Deselect the documents you want to remove and click Close. Vault removes the documents from the Commitment.

Deleting Commitments

In some cases, you may need to delete a Commitment that was created in error or is a duplicate of an existing Commitment. Before you can delete a Commitment, you must first remove any correspondence documents from the Commitment.

Complete the following steps to delete a Commitment:

  1. Navigate to Submission Mgmt > Commitments and locate the Commitment you want to delete. 
  2. From the All Actions menu next to the Commitment Name, select Delete. 
  3. In the confirmation dialog, click Continue to confirm that you want to delete the Commitment. Vault deletes the Commitment and removes it from the All Commitments page.