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VERA Integration

Overview

qTest includes the ability to integrate with VERA, which is an e-signature tool used for validation testing within a LifeSciences FDA regulated environment. This integration allows you to route a Test Run to VERA for e-signature approval after the Test Run is executed. 

NOTE: E-signature integration will not be included in the qTest subscription. You must have a VERA license in order to use this feature with qTest.

Compatibility Matrix

qTest Version
9.6.1 OnPremise
current OnDemand version

Enable Integration

Prerequisite

Contact Tx3 to configure your VERA instance to allow integration with qTest. Follow these instructions. 

User Permissions Needed:

  • qTest Site Admin

Before you can route a Test Run for Approval, you must enable the VERA integration. 

  1. In the project, you are enabling the VERA Integration, select the Gear icon.
  2. In the drop-down menu, select Integration Settings.
  3. In the External Systems panel on the left-hand side, select the VERA tab.
  4. The VERA integrations page loads.
  5. Enter the following VERA URL in the URL field:
    https://<VERA Server>:<port>/callbacks/qtest/route_action
    vera_integration_url.png
  6. Toggle the Activation status to ON and Save.
  7. Once the integration is saved, you will need to refresh your browser for the changes to take effect.
    save_integration_popup.png


VERA Integration Information

When the integration is enabled, qTest Test Run Properties will update with additional fields associated with the VERA integration. 

The qTest Test Run Properties display the following VERA information: 

  • VERA Approval Route
  • VERA Approval Status
  • VERA ID
  • VERA Pending Tasks
    unpopulated_vera_fields.png

This VERA information that populates in the qTest Test Run Properties is available in the Test Run Data Query and the Test Run Export Reports.

Test Run Data Query

data_query_vera_fields.png

Test Run Export Report

Test_Run_Export.png

Route Test Runs to VERA for Approval

Now that the integration is enabled, you are able to route Test Runs to VERA for approval.

User Permissions Needed:

  • Edit Test Run

Route Test Run

  1. In the VERA integrated project, a Route for Approval button is available on the Test Run after the Test Run has been executed.
  2. Select Route for Approval and qTest will send the Test Run to VERA for Approval.
  3. A dialog opens to verify you want to lock the Test Run. Meaning, that no changes can be made on the Test Run and cannot be further executed.
    test_run_locked.png
  4. Select Proceed and the Test Run is routed for Approval. The following VERA fields will populate:
    • Vera Approval Status=Routing
    • VERA Approval Route=details on the Approval Tasks, Status, Reviewer, Date, and Level for completed or pending Test Run approval
    • VERA Pending Tasks=shows Approvers with a Pending status
    • VERA ID=populates with the ID of the Approval Recordroute_for_approval_vera.png
  5. After routing the Test Run for Approval to VERA, the Test Run is locked and you will receive a red, banner notification. 
    vera_test_run_routed_for_approval_and_locked.png

Approve a Routed Test Run

User Permissions Needed:

  • Edit Test Run

Approve a Test Run

  1. Open the Test Run that has been routed for Approval.
  2. In the VERA Approval Route field, select the hyperlink associated with your Reviewer title.
    approver_hyperlink.png
  3. The hyperlink redirects you to VERA and you will enter your login information and select Continue.
    vera_username.jpg
  4. Enter your password and select Login.
    vera_password.jpg
  5. After reading through the relevant details in VERA, Approve the test run. You can do this 2 ways:
    • Select Approve to the right of the "Approval Task" within the "Approval Route" OR
    • Select Approve in the blue banner at the bottom of the window
      approve_in_vera.jpg
  6. After selecting Approve, the Approve Selected Entity dialog opens. You will apply your Electronic Signature, by typing in your username and password and selecting Submit.
    IMPORTANT: Under Title 21 CFR Part 11 of the Code of Federal Regulations, this is considered your "electronic signature" and therefore validates your approval.
    e_sig_screen.jpg
  7. In qTest, select the Reload button on the Test Run and the browser will refresh. 
    reload_test_run.png
  8. VERA fields will reflect the status of the current Approval process.
    • VERA Approval Route 
      approve_notifcation_in_vera_approval_route_field.png
    • VERA Pending Tasks
      vera_pending_tasks_after_first_approval.png
  9. This same Approval process will continue until all Reviewers have applied their e-signature. 
  10. Once the VERA Approval process is completed the Test Run Properties display the following:
    • Vera Approval Status=Approved
    • VERA Approval Route=details on the Approval Tasks, Status, Reviewer, Date, and Level for completed Test Run approvals
    • VERA Pending Tasks=emptied
    • VERA ID=ID of the Approval Record

Reject a Routed Test Run

User Permissions Needed:

  • Edit Test Run

Reject a Test Run

  1. Open the Test Run that has been routed for Approval.
  2. In the VERA Approval Route field, select the hyperlink associated with your Reviewer title.
    approver_hyperlink.png
  3. The hyperlink redirects you to VERA and you will enter your login information and select Continue.
    vera_username.jpg
  4. Enter your password and select Login.
    vera_password.jpg
  5. After reading through the relevant details, Reject the test run.
    • Select the Reject button to the right of the "Approval Task" within the "Approval Route" OR
    • Select Reject in the blue banner at the bottom of the window
      vera_reject_button.png
  6. The Reject Selected Entity dialog opens.
  7. Enter your Rejection Reason and Submit.
    vera_rejection_reason.png
  8. In qTest, select the Reload button on the Test Run and the browser will refresh. 
    reload_test_run.png
  9. VERA fields will reflect the status of the current Approval process.
    • VERA Approval Route
      rejection_vera_approval_field.png
    • VERA Approval Status=Rejected
    • VERA Pending Tasks=emptied

Cancel an Approval Route

User Permissions Needed:

  • Edit Test Run

Only the qTest user that routed the Test Run to VERA can cancel the Route for Approval.

In the event you need to cancel an approval, follow these instructions:

  1. In the Test Run, you have routed for approval, you will notice the VERA Approval Status has updated to Pending and the Test Run is locked for modification or execution.
    cancel_approval_in_test_run.png
  2. Select Cancel Approval, and a pop-up confirming you want to cancel the route for approval will open. Select Proceed.
    confirm_cancellation.png
  3. The Test Run Properties will update to reflect the cancellation and the Route for Approval button is enabled, as seen in the image below.
    cancelled_test_run.png

Additional Configuration Options

qTest Test Run Properties

Tx3 has the capability to configure additional qTest Test Run properties, that are not returned by default, to populate in the VERA UI. However, this must be configured through your Tx3/VERA contact. 

Multi-Level Approval Requirement

In the event, you want to incorporate a single Approval process for a Test Run, not the default multi-level, you will need to setup a custom Site Level Field in qTest. This use case would be for a low-priority Test Run or for an item that only requires one e-signature.

This custom Site Level Field allows you to distinguish, at the Test Run level, whether a Single Reviewer, or Multiple Reviewer process is required. Tx3 can configure VERA to pull this custom Site Level Field as a Test Run Property, and return the VERA Approval Route field to only require a single Reviewer e-signature for Test Run completion.

Follow these instructions on how to create this custom Site Level Field and apply it at the Test Run level. 

IMPORTANT: Notate the EXACT Display Names for the custom Site Level Field, and the values so that Tx3 can match the data. 

Example Custom Site Level Field:

  • Display Name=Approval Requirement
  • Field Type=Combo Box
    create_custom_field_for_single_approval.png
  • Display Name (value)=
    • Single Approver only
    • Multi-level Approvers required
  • Default Value=you choose
  • Active=select all options for selection on the Test Run

example_custom_site_field_for_single_approver.png

For additional information on Tx3 and VERA, please refer to their user guides.

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