Managing Documents

The Submission Mgmt > Library tab allows Vault Admins, Submission Managers, and Document Managers to create, edit, and view documents throughout the document lifecycle.

Document Management Overview

Managing your documents in Vault RIM Basics follows a general process:

1. Create and classify your documents.
2. Author and review your documents.
3. Approve your documents to indicate that they are ready for submission.

The following diagram provides a more detailed look at the document management workflow as they transition through their lifecycle:

Document Statuses

Documents in Vault RIM Basics use the following statuses:

• Draft: The document has been created, but it is not approved or in an active workflow.
• In Authoring: The document is currently in the Authoring/Review workflow.
• In Approval: The document has been sent for approval.
• Approved: The document has been approved manually or through an Approval workflow.
• Superseded: A newer major version of the document has been created.
• Obsolete: The document is obsolete and is no longer applicable.

Document Versions

When you first create a document, it is assigned the minor version 0.1. Each time the document is edited and checked back in during the Authoring/Review workflow, Vault increments the version by 0.1. When the document is approved, Vault assigns the document the major version 1.0. For example, if a document is in minor version 0.6, Vault assigns the document the major version 1.0 when it is approved.

When you create a new draft of document version 1.0, Vault assigns the draft the minor version 1.1. Once the draft document is approved, Vault assigns the document the major version 2.0 and sets the status of the document with the major version 1.0 to Superseded to indicate that a newer version of the document exists.

Document Classifications

Document classifications are a way to organize your documents into categories. Documents can have an overarching type, which can include multiple subtypes, which then include individual classifications. For example, you can create a document with a type of Clinical, a subtype of Study Reports, and a classification of Microbiology Report.

When you upload a document, you can choose to classify the document during upload, or create the document as unclassified and add a classification later.

To view all document classifications available in Vault RIM Basics, navigate to the Submission Mgmt > Library tab and click View all next to the Document Types filter in the left panel.

Automatic Document Classification

For Vaults with more than 1,500 classified and approved documents, Vault automatically classifies new documents based on your existing document classifications. If Vault has classified a document incorrectly, you can manually reclassify the document. Vault’s automatic classification accuracy improves over time based on new documents you have uploaded and classified, as well as documents you have manually reclassified.

Viewable Renditions

When you upload a new document or new document version, Vault automatically generates a viewable PDF rendition of the document. You can view and download viewable renditions of documents by opening the document in the Submission Mgmt > Library tab.

Viewing Documents

Vault offers several different ways to view your documents. You can select a view in the left panel to view all documents, your documents, recent documents, and favorites. You can also select the layout type that Vault uses to display your list of documents.

Once you have located the document you want to view, click the document name to open the document and view its details.

Creating Documents

You can create new documents in Vault by uploading a document, creating a placeholder document, creating a document from a template, or creating a new draft of an approved document.

Uploading Documents

Complete the following steps to upload a document:

1. In the Submission Mgmt > Library tab, click Create.
2. In the Create Document dialog, select Upload and click Continue.
3. On the Upload Files page, click Upload, select the document you want to upload, and click Open. Alternatively, drag and drop the document file you want to upload onto the Drag and drop files to upload here section on the Upload Files page.
4. To remove a document from the list of files to be uploaded, click the X button next to the document name in the right panel.
5. Select Classify documents now if you want to classify the document. Otherwise, select Classify documents later if you want to edit the document to add the classification at a later date.
6. If you selected Classify documents now, select the document’s classification from the Choose document type drop-down.
7. Click Next. A message is displayed on the Upload Files page when the files have been successfully uploaded.
8. Enter the Name and Title of the document.
9. From the eSignature Approval Required drop-down, select Yes if the document requires an eSignature, or select No if the document does not require an eSignature.
10. For documents using the Labeling type, select whether the labeling document is Approved for Use, Currently In Use, or Historical from the Additional Labeling Information drop-down.
11. Select the appropriate Product Family.
12. Optional: Search for and select any existing Applications and Submissions that the document is associated with.
13. Click Save. The system saves the document in a Draft state, generates a viewable rendition of the document, and displays the document’s details.

Creating Placeholder Documents

A placeholder document is a document record in Vault that does not yet have an uploaded document. You can create a placeholder document record now and upload a document file later.

Complete the following steps to create a placeholder document:

1. In the Submission Mgmt > Library tab, click Create. The Create Document dialog is displayed.
2. In the Create Document dialog, select Placeholder and click Continue.
3. On the Upload Files page, select the document’s classification from the Choose document type drop-down and click Next.
4. On the Create Placeholder page, enter the Name and Title of the document.
5. From the eSignature Approval Required drop-down, select Yes if the document requires an eSignature, or select No if the document does not require an eSignature.
6. For documents using the Labeling type, select whether the labeling document is Approved for Use, Currently In Use, or Historical from the Additional Labeling Information drop-down.
7. Select the appropriate Product Family.
8. Optional: Search for and select any existing Applications and Submissions that the document is associated with.
9. Click Save. The system saves the document record in a Draft state and displays the document’s details.

Creating Drafts from Approved Documents

Complete the following steps to create a draft from an approved document:

1. From the Submission Mgmt > Library tab, open the approved document you want to create a draft from.
2. From the All Actions menu, select Create Draft.
3. Select an action in the Create Draft dialog:
   • To create a new draft using the existing file, click Copy.
   • To upload a new file, click Upload, select the document file you want, and click Open.
4. Optional: Enter a Version Description.
5. Click Create. Vault creates a new document in the Draft state and assigns it the next minor version.

Adding Documents Using the Document Inbox

The Library includes the Document Inbox view, which allows you to drag and drop documents to upload to Vault. When you drag and drop a file into the Document Inbox, Vault uploads the file as an unclassified document. You can also forward email conversations and attachments to your Document Inbox and Vault uploads both the email and attachments as unclassified documents.

To upload emails and attachments to your Library using the Document Inbox, forward the emails and attachments to inbox@(Your Vault URL).com, for example, inbox@myvaultaddress.veevavault.com. You can find your Vault URL in the address bar of your web browser.

The Document Inbox in Vault RIM Basics is especially useful for documenting Health Authority correspondence related to your submissions. When you forward an email or correspondence attachment to the Document Inbox, you can classify the documents using the appropriate correspondence document type and associate the documents with a specific application, submission, and product family.

Document Templates

Document templates allow you to quickly create new documents from a configured template. When you create a new document from a template, Vault copies the template file and uses that copy as the source file for the new document. This process bypasses the content upload process and allows for more consistent document creation.

Creating Document Templates

Complete the following steps to create a document template:

1. In the Submission Mgmt > Library tab, click Create. The Create Document dialog is displayed.
2. Select Upload and click Continue. The Upload Files page is displayed.
3. Click Upload, select the document template you want to upload, and click Open. Alternatively, drag and drop the document template you want to upload onto the Drag and drop files to upload here section on the Upload Files page.
4. Select Classify documents now.
5. From the Choose document type drop-down, select Templates.
6. Click Next. A message is displayed on the Upload Files page when the file has been successfully uploaded.
7. Enter the Name for the template.
8. In the Template Document Type field, search for and select the document type for the template.
9. From the eSignature Approval Required drop-down, select Yes if documents created from the template will require an eSignature, or select No if documents created from the template will not require an eSignature.
10. Click Save. The system saves the template in a Draft state, generates a viewable rendition of the template, and displays the template’s details.
11. To make the template available for use, select Change State to Approved from the Workflow Actions menu. A dialog is displayed prompting you to confirm the status change.
12. Click Yes to set the template status to Approved. The template is now approved and can be used to create documents.

Creating Documents from a Template

Complete the following steps to create a document from a template:

1. In the Submission Mgmt > Library tab, click Create.
2. In the Create Document dialog, select Document from Template and click Continue.
3. On the Create Document from Template page, select the document type from the Choose document type drop-down. Note that Vault only displays document types that have an associated template.
4. From the Choose template drop-down, select the template you want to use.
5. Click Next.
6. Enter a Name for the document.
7. Select the Product Family for the document.
8. Search for and select any Applications the document is associated with.
9. Search for and select any Submissions the document is associated with.
10. Click Save. The system saves the document in a Draft state, generates a viewable rendition of the document, and displays the document’s details. You can now edit the document or route the document through the Authoring/Review workflow for other users to edit the document with the appropriate content.

Editing Documents

Complete the following steps to edit a document:

1. From the Submission Mgmt > Library tab, open the document you want to edit.
2. To classify an unclassified document, click Classify in the Information panel, select the document’s Type, Subtype, and Classification, and click OK. Vault adds the document’s classification.
3. To reclassify a document, click Reclassify in the Information panel, select a new Type, Subtype, and Classification, and click OK. Vault updates the document’s classification.
4. To upload a file to a placeholder document, click Upload File, select the file you want to upload, and click Upload. Alternatively, drag and drop the file you want to upload onto the This placeholder has no content section on the document page.
5. To edit a document’s information click Edit Fields in the Information panel heading, edit the information as needed, and click Save. Vault saves the updated document information.

Authoring & Reviewing Documents

Once a document is ready for review or needs to have its content edited, you can route the document through the Authoring/Review workflow. You can edit a document’s contents using collaborative authoring if it is enabled by your organization, or you can edit a document without collaborative authoring by checking it out, editing it, and checking it back in.

Starting the Document Authoring/Review Workflow

Complete the following steps to start the document Authoring/Review workflow and assign the Authoring/Review task:

1. From the Submission Mgmt > Library tab, open the document you want to assign for authoring and review.
2. From the Workflow Actions menu, select Start Authoring/Review. The Start Workflow dialog is displayed.
3. From the Authors/Reviewers drop-down, select the users or groups you want to assign the document to and select a Due Date.
4. Optional: Enter any additional instructions for the assigned users.
5. Click Start. Vault updates the document status to In Authoring/Review and assigns an Authoring/Review task to the users you selected.

Completing Authoring/Review Tasks

When you have been assigned an Authoring/Review task, Vault displays the task on the Submission Mgmt > Home tab.

Complete the following steps to complete an Authoring/Review task:

1. From the Submission Mgmt > Home tab, select the All Tasks view to view your assigned tasks.
2. Click Show more on the task to view additional task information.
3. Click the document name or click Continue on the Authoring/Review task you need to complete. Vault opens the document and displays a task banner with the task due date, instructions, and task owner.
4. Review and edit the document as needed. The steps for editing the document are different depending on whether your organization uses collaborative authoring.
5. Once you have edited and reviewed the document and it is checked back into Vault, click Complete in the task banner. Vault displays a dialog asking you to confirm that you have completed the task.
6. Click Complete in the dialog. Vault updates the document status to Draft, removes the task from your Home tab, and sends a notification to the task initiator to indicate that the task is complete.

Approving Documents

The document approval process in Vault RIM Basics depends on whether the document requires an eSignature for approval. If a document does not require an eSignature, you can manually approve the document or assign an Approval task to a user to approve without a signature. If a document requires an eSignature for approval, you can assign an eSignature approval task to users or groups to capture their signature before Vault changes the document status to Approved.

Manually Approving Documents

If a document does not require an eSignature for approval, you can manually approve it.

Complete the following steps to manually approve a document:

1. From the Submission Mgmt > Library tab, open the document you want to approve.
2. From the Workflow Actions menu, select Change State to Approved. Vault displays a dialog asking you to confirm that you want to change the document to Approved.
3. Click Yes. Vault updates the document status to Approved.

Starting the Approval Workflow

If a document does not require an eSignature, you can send it to a user or group for approval without requiring the users to enter their credentials when approving or rejecting the document.

Complete the following steps to start the Approval workflow and assign the Approval task:

1. From the Submission Mgmt > Library tab, open the document you want to assign for approval.
2. From the Workflow Actions menu, select Start Approval. The Start Workflow dialog is displayed.
3. From the Approvers drop-down, select the users or groups you want to assign the document to for approval.
4. Enter a Due Date.
5. Optional: Enter any additional instructions for the assigned users.
6. Click Start. Vault updates the document status to In Approval and assigns an Approval task to the users you selected.

Starting the eSignature Approval Workflow

If a document requires an eSignature for approval, it must go through the eSignature Approval workflow to capture the necessary signatures before its status is changed to Approved. You cannot manually approve a document that requires an eSignature for approval.

You can start the eSignature Approval workflow for multiple documents at once using the Cart if all documents in the Cart require an eSignature. If one or more documents in the Cart do not require an eSignature, the Start eSignature Approval option is unavailable in the Cart.

Complete the following steps to start the eSignature Approval workflow and assign the eSignature Approval task:

1. From the Submission Mgmt > Library tab, open the document you want to assign for eSignature approval.
2. From the Workflow Actions menu, select Start eSignature Approval. The Start Workflow dialog is displayed.
3. From the Approvers drop-down, select the users or groups you want to assign the document to for approval.
4. Enter a Due Date.
5. Optional: Enter any additional instructions for the assigned users.
6. Click Start. Vault updates the document status to In Approval and assigns an eSignature Approval task to the users you selected.

Completing Approval Tasks

When you have been assigned an Approval task, Vault displays the task on the Submission Mgmt > Home tab.

When completing an Approval task, you can either approve the document or reject it by selecting a verdict of Approved or Not Approved.

When you select the verdict Approved, Vault changes the document status to Approved. If multiple users are assigned an Approval task for a document, all users must select Approved for the document status to change to Approved. Once a document is Approved, Vault sends a notification to the task initiator to indicate that the document is Approved. In addition, Vault changes the document version to the next major version.

When you select the verdict Not Approved, Vault changes the document status back to Draft. If multiple users are assigned an Approval task for a document and at least one user selects Not Approved, the document is not approved and the status is changed back to Draft. Vault sends a notification to the task initiator to indicate that the document was rejected.

Complete the following steps to complete an Approval task:

1. From the Submission Mgmt > Home tab, select the All Tasks view to view your assigned tasks.
2. Click Show more on the task to view additional task information.
3. Click the document name or click Continue on the Approval task you need to complete. Vault opens the document and displays a task banner with the task due date, instructions, and task owner.
4. Determine whether to approve or reject the document and click Complete. In the Mark Documents Approved/Not Approved dialog:
   • To reject the document, select Not Approved, enter a Reason for rejection, and select your Capacity.
   • To approve the document, select Approved, select your Capacity. If the Approval task requires an eSignature, enter your credentials. If your organization uses Single Sign-on (SSO), your signature is captured using SSO.
5. Click Complete. Vault removes the task from your Home tab. Once Vault has captured all of the necessary signatures, the document status is updated to Approved or Draft depending on the signature outcome.