Managing Vault Quality Basics Users

Vault Admins are responsible for creating and managing users in Vault Basics. You can perform all of the user administration functionality from the Admin > Users & Groups tab.

About User Access

You can provide users access to Vault Quality Basics based on their role at your organization using security profiles, system assignments, and application licenses.

Security profiles allow you to define whether a user should have Admin access, full access, or read-only access to Vault Quality Basics. define what each user can do in the system. System assignments allow you to grant additional system access to the user to allow them to perform specific sets of tasks based on their role in your organization. Application licenses allow you to further specify the user’s level of access to each Vault Quality Basics application.

Security Profiles

The following security profiles are available for Vault Quality Basics users:

  • Vault Admin: This security profile allows users to create and manage users, create reference data, view all records and documents, manage workflow participants, and start workflows. You can select system assignments for this security profile to grant additional access.
  • Full User: This security profile allows users to create documents, create Document Change Controls, and participate in authoring & approvals. You can select system assignments for this security profile to grant additional access.
  • Read-Only User: This security profile provides users with read-only access to documents in a steady state. You can select the Learner system assignment for this security profile to allow users to complete Training Assignments. No other system assignments are allowed.

System Assignments

You can select system assignments for users to allow them to perform additional functionality based on their role in your organization. The following system assignments are available:

  • Document Control: This system assignment allows users to view and manage all documents, expedite document release, complete periodic document reviews, manage workflow participants, and start document workflows.
  • QA: This system assignment allows users to be selected as the QA Approver on documents, Document Change Controls, and QMS records. Within Quality Basics: QMS, users with this system assignment can see all records, manage team participants, create Extension Requests, start workflows, and cancel incorrectly created Change Controls and Deviations.
  • Training Admin: This system assignment allows users to manage the Training Matrix, including Learner Roles, Curricula, and Training Requirements.
  • Learner: This system assignment allows users to complete training assignments. We recommend that you assign the Learner system assignment to all users to allow them to complete training assignments.
  • QMS User: This system allows users to view all QMS records and be selected as an Approver on Change Controls and Change Actions. In addition, users with this system assignment can be selected as the Owner of CAPA Actions, Change Actions, Effectiveness Checks, Investigations, and Impact Assessments. When you assign a user this system assignment, you must also specify their QMS Owner and Creator permissions:
    • QMS Owner Permissions: These permissions allow users to be selected as the Owner of either Change Control, Deviations, or both.
    • QMS Creation Permissions: These permissions allow users to create either Change Controls, Deviations, or both.

Application Licenses

The following application licenses are available for Vault Quality Basics users:

  • QualityDocs License:
    • Full User: This license type allows access to Quality Basics: QualityDocs for users with a Vault Admin or Full User security profile.
    • Read-Only User: This license type allows read-only access to Quality Basics: QualityDocs for users with the Read-Only User security profile.
  • Training License:
    • Full User: This license type allows access to Quality Basics: Training for users with the Vault Admin or Full User security profile and the Training Admin system assignment.
    • Learner User: This license type allows users with any security profile and the Learner system assignment to complete training assignments and view related learning materials in Quality Basics: Training.
  • QMS License:
    • Full User: This license type allows access to Quality Basics: QMS for users with the Vault Admin or Full User security profile and the QMS User system assignment.

Creating Users

When you create a new Vault Quality Basics user for your organization, you can select the user’s security profile, system assignments, and application licenses. If your organization uses Quality Basics: Training, Vault automatically creates a Learner record for the user.

If a user record for one of your users already exists in one of your other domains, such as Vault Clinical Basics or Vault RIM Basics, you can select that existing user to automatically populate some of the user’s information.

Vault requires all new users not using SSO (Single Sign-On) to update their password the first time they log in.

Creating New Domain Users

Complete the following steps to create a new domain user:

  1. Navigate to the Admin > Users & Groups tab and click Create.
  2. On the Create User page, select Create Domain User from the Domain User drop-down.
  3. In the Create Domain User dialog, enter the user’s First Name, Last Name, User Name, and Email.
  4. Optional: Click Edit in the Image field, upload an image to use for the user’s profile, and click OK.
  5. Select a Language and Locale for the user. These options control localization options for the user, such as number and date formats and label language.
  6. Select a Timezone for the user. Vault stores time and date information in UTC (Coordinated Universal Time) but displays that information to users in their local time zones.
  7. Click Save. Vault fills out the Domain User and General Info sections based on the information you entered.
  8. Optional: Enter the user’s Mobile phone number and select their Manager. The selected Manager can complete Verification tasks for the user’s training assignments and monitor their training progress on the My Team tab.
  9. Select the user’s Security Profile.
  10. Select the appropriate System Assignments.
  11. Select the appropriate Application Licenses.
  12. Select the Basic Security Policy.
  13. If your organization uses SSO, enter the user’s Federated ID to associate the user record with the user ID used for SSO.
  14. Select the Activation Date if you want the account to become active at a later date
  15. Check the Send Welcome Email on Activation Date checkbox if you want the user to receive a welcome email.
  16. Enter any optional information as needed.
  17. Click Save. New users are active immediately unless you select a later activation date.

Creating Users for Existing Domain Users

Complete the following steps to create a domain user for a user that already exists in another domain:

  1. Navigate to the Admin > Users & Groups tab and click Create.
  2. On the Create User page, search for and select the existing domain user from the Domain User drop-down. Vault fills out the General Info section with the user’s information.
  3. Optional: Enter the user’s Mobile phone number and select their Manager. The selected Manager can complete Verification tasks for the user’s training assignments and monitor their training progress on the My Team tab.
  4. Select the user’s Security Profile.
  5. Select the appropriate System Assignments.
  6. Select the appropriate Application Licenses.
  7. Select the Basic Security Policy.
  8. Select the Activation Date if you want the account to become active at a later date
  9. Check the Send Welcome Email on Activation Date checkbox if you want the user to receive a welcome email.
  10. Enter any optional information as needed.
  11. Click Save. New users are active immediately unless you select a later activation date.

Creating Cross-Domain Users

Cross-domain users can log in to any Vault they have access to using their existing home domain login credentials or using SSO if it is enabled for your organization.

Complete the following steps to create a new cross-domain user for Vault Quality Basics:

  1. Navigate to the Admin > Users & Groups tab and select Create Cross Domain User from the All Actions menu.
  2. In the Create Cross Domain User dialog, enter the full User Name of the existing user.
  3. Select the Security Profile and Application Licenses.
  4. Click Save to save the cross-domain user information. Vault automatically populates the remaining required profile fields based on the existing user information from the home domain.

Registering VeevaID Users

Complete the following steps to register a VeevaID user:

  1. Navigate to the Admin > Users & Groups tab and select Register VeevaID User from the All Actions menu.
  2. In the Register VeevaID User dialog, enter the user’s email address.
  3. Click Invite User to VeevaID.
  4. Enter the user’s First Name and Last Name.
  5. Select the Language, Locale, and Timezone.
  6. Select the Security Profile and Application Licenses.
  7. Click Send Invite. Vault sends an email to the user to complete the registration process. You will receive an email notification when the user has completed their registration.

Editing User Information

To edit a user’s information, open the user record from the Admin > Users & Groups tab and click Edit. Edit the information as needed and click Save to save the changes. See Creating New Domain Users for more information about the fields available on a user’s profile.

The following circumstances apply when editing a user’s record:

  • When you update information for cross-domain users, Vault syncs the changes across domains.
  • You can update the User Name field, but you cannot edit the domain to which the user belongs.

Deactivating & Reactivating Users

If a user leaves your organization and no longer needs to be active in the system, Vault Admins can fully deactivate the user.

Complete the following steps to deactivate or reactivate a user:

  1. From the Admin > Users & Groups tab, open the user record that you want to deactivate.
  2. From the Workflow Actions menu, select Make User Inactive.
  3. Click Yes to confirm that you want to deactivate the user.
  4. If you need to reactivate the user, select Make User Active from the Workflow Actions menu.
  5. Click Yes to confirm that you want to reactivate the user.