Working with Audit Room

Audits can often be time-sensitive, time-consuming, and meticulous. Vault QMS provides an Audit Room management solution to facilitate the time-sensitive activity of conducting third-party audits. Team members participating in an audit can create requests from the front room, associate them with documents or attachments, and manage them in the back room. Vault allows them to communicate the priority, status, and fulfillment of each request, publishing them to inspectors when ready. The functionality is facilitated by the Audit Room application page, a collaborative drag-and-drop interface that assists organizations with responding to requests and efficiently presenting information to auditors.

This feature is only available in systems with Vault QMS enabled and relies on Admin configuration to integrate seamlessly with your existing Audit workflows and lifecycles.

Relevant Roles

Vault QMS provisions the following roles to support the Audit Room functionality through their participation in the audit process:

  • Front Office: The individual who is in the front room during the audit and is responsible for creating new inspection requests. They are the only member capable of publishing requests to Inspectors.
  • Fulfiller: A team member who is assigned requests and is responsible for fulfilling them and providing a response.
  • Inspector: Third-party auditor who has limited access to Vault and can only access published requests.

Creating Inspections

Audit Room functionality relies upon the Inspection object type on the Audit object, which captures information about the third-party audit including the scope, purpose, and the organization that is conducting the audit.

To create an Inspection:

  1. Navigate to the Inspection custom object tab or to Business Admin > Inspections.
  2. Click Create.
  3. Populate the required fields.
  4. Indicate an Audit Host and Auditor Organization. You can assign an existing Person to be the Audit Host or you can create a new Person record.
  5. Click Save.

Upon saving, Vault navigates you to the Inspection record’s details page. From this page, you can assign users to Quality Team roles, such as Front Office or Fulfiller, and edit the record to associate the Inspection with a Scribe Notes document. To assign inspectors, navigate to the Persons section.

Following the creation of Inspection Requests, you can access the Audit Room interface by clicking Enter Audit Room from the record’s Actions menu. This action may only be available if the record is In Audit.

Creating Inspection Requests

The Inspection Request object is a child of an Inspection record that captures an inspector’s request, collects responses to said request, and allows for attachments and references to existing documents in your Vault. All documents and attachments tied to an Inspection Request may be accessible to the Inspector upon publishing.

To create an Inspection Request:

  1. Navigate to an Inspection record and click Create under the Inspection Requests section. Alternatively, you can create new requests by clicking Create from the Audit Room interface.
  2. In the dialog, populate the required fields, such as Category, Request, and Priority.
  3. Select an Inspector from the drop-down and optionally, the Inspector Status.
  4. Optional: Populate the fields in the Response section.
  5. Click Save.

Upon saving, Vault navigates you to the Inspection Request record in its initial lifecycle state. From the Response section of the record, you can populate the response in addition to selecting a user to the Assignee and Reviewed By fields. From the object record sections, you can relate requests to each other, upload attachments, and capture a response to the request. Assigned users can then utilize the drag-and-drop Audit Room interface to progress each Inspection Request through its lifecycle.

Adding Documents

You can add one (1) or more reference documents to an Inspection Request record by clicking Create from the Inspection Request Documents section. From the creation page, select a Document, indicate a specific document Version, then click Save. This feature also utilizes CrossLinks to display documents in other Vaults within the same domain.

Adding Attachments

In addition to reference documents, you may also be able to upload attachments to an Inspection Request by clicking Upload from the record’s Attachments section. From this section, you may be able to view, edit, delete, or download attachments depending on the lifecycle state of the Inspection Request and your assigned security profile.

Assigning Inspectors

Inspectors are identified as such by the Inspector object type on the Person object. To add Inspectors, navigate to the Persons section on an Inspection record and click Add. In the dialog, select a Person or click Create to create a new Person record. In the Create Person dialog, ensure you select the Inspector type from the drop-down.

If configured by an Admin, when an Inspection record enters the In Audit lifecycle state, an entry action handles the identification of the person referenced on the record and grants them access to Vault. Alternatively, you may be able to initiate the Invite Inspectors to VeevaID user action from the record’s Actions menu.

The desired Inspector must already be assigned the appropriate application role. If successful, Vault modifies the type of the Person record to be VeevaID and sends the person a VeevaID invitation. If the Inspector already has an active VeevaID, Vault sends them a welcome-back email. If the Inspector does not have an active VeevaID, they receive a welcome email to register.

Inspector View

Once an Inspector completes their VeevaID registration, they can log in and access a limited version of Vault QMS. From the Inspections tab, they can view all Inspection records in which they’re participating. Clicking on a specific Inspection record navigates them to the record details page, from which they can review the details made visible to them. Inspectors can only view published Inspection Requests associated with a particular Inspection. Inspectors may also have access to referenced documents or attachments from their respective sections on the Inspection Request record.

Reporting on Inspections

You can utilize Vault’s existing reporting and dashboard functionality to view data across the Audit Room. From these reports, you can gather response metrics to monitor trends or insights that may be useful for your audit response teams.

To create Inspections and Inspection Requests, your security profile must grant you Create permissions for the Audit and Inspection Request objects.

To publish Inspection Requests, your application role on the Fulfilled state of the Inspection Request Lifecycle must have Execute permissions for the Publish to Inspectors action. Only users with a Front Room application role can successfully execute this action.

To access Scribe Notes, your security profile must grant Read permission for the Inspection object type on the Audit object.

Your security profile must grant Create permissions on the Inspection Request - Document object to add referenced documents to an Inspection Request. You must also have Edit permissions on the Inspection Request - Document based on the lifecycle state of the Inspection Request record.

To view the Quality Teams section on a record, a user requires Read permission on the relevant team-enabled object. To add, remove, or otherwise manage Quality Team members, a user requires Edit permission on the relevant team-enabled object.