Get approval for requirements in Vera

qTest lets you integrate your testing with Vera, which is an e-signature tool for validation testing within a LifeSciences FDA regulated environment. This integration allows you to route a requirement to Vera for e-signature approval, before you can use it to build and organize test cases.

This article covers the standard workflow for Vera approvals. If you're using a custom workflow in Vera (opens in a new tab), talk to your site administrator about approval processes.

Before you start

To implement Vera approval in your qTest project, you need to complete the following :

• Get user permissions to edit requirements in qTest

• Set up integration with Vera

• Turn on approval for requirements

• Enable the Vera Integration Actions user profile permission under Requirements for the Vera Service Account you've added to qTest

Route requirements to Vera for approval

To route your requirement to Vera, follow these steps:

1. In your Vera-integrated project in qTest, select the Route for Approval option from the Actions dropdown on your requirement.

2. Select Proceed to verify you want to lock the requirement and send it for approval.

   Once you send the requirement to Vera for approval, qTest updates the Vera fields with the following information:

   • Vera Approval Status: Routing

   • Vera Approval Route: Displays details about the Approval Task, Status, Reviewer, Date, and Level for completed or pending requirement approval.

   • Vera Pending Tasks: Lists the reviewers who still have a Pending status.

   • Vera Rejection Reason: Lists the reason given in Vera if the requirement is rejected.

   • Vera Revision Number: This revision number is set to 1 when the requirement is created, and goes up incrementally each time the requirement is revised.

   • Vera ID: ID of the approval record.

3. After you've sent the requirement for approval, you can no longer edit the requirement, unless the reviewer rejects your request.

   You can also unlock requirements to edit them with either of the following methods, but you need to get the requirement approved again:

   • Select Cancel Approval to cancel a routed approval.

   • Select Revise to revise an approved requirement.

Approve or reject a routed requirement

Once you've routed your requirement to Vera for approval, reviewers need to take a look at the contents in Vera before they can Approve or Reject the requirement.

Requirements are approved if every reviewer listed in the Vera Approval Route field gives their okay. If a single reviewer rejects, you need to start the full review process again, after taking the given Vera Rejection Reason into account.

Approve a requirement

Reviewed that requirement and everything looks great? Then it's time to approve it from Vera.

As a reviewer, follow these steps to approve a requirement in Vera:

1. In qTest, open the requirement that's routed for approval.

2. In the Vera Approval Route field, select the link associated with your Approval Task to open Vera.

   
   Use the link associated with your Approval Task to navigate to Vera.

3. Sign in to Vera to continue.

4. If the requirement is in compliance, select Approve.

5. In the Approve Selected Entity dialog, enter your username and password, and select Submit to apply your electronic signature.

   Under Title 21 CFR Part 11 of the Code of Federal Regulations, entering your credentials is considered your "electronic signature" and validates your approval.

6. In qTest, select Reload to refresh the Vera fields on your requirement.

   Once all reviewers submit approvals, qTest updates the Vera fields with the following information:

   • Vera Approval Status: Approved

   • Vera Approval Route: Details on the Approval Task, Status, Reviewer, Date, and Level for completed requirement approvals.

   • Vera ID: ID of the approval record.

Reject a requirement

Not everything's perfect the first time around? If you review a requirement and find an element that's not in compliance, you need to reject the requirement from Vera to restart the review process.

To reject a requirement, follow these steps:

1. In qTest, open the requirement that's routed for approval.

2. In the Vera Approval Route field, select the link associated with your reviewer title to navigate to Vera.

3. Sign in to Vera to continue.

4. If the requirement is not in compliance, select Reject.

5. Enter the reason for rejection in the Reject Selected Entity dialog, and then Submit.

6. In qTest, select the Reload icon on the requirement to refresh the browser.

   After a requirement is rejected, qTest updates the Vera fields with the following information:

   • Vera Approval Status: Rejected

   • Vera Approval Route: Displays details on the Approval Task, Status, Reviewer, Date, and Level for the all pending or completed approvals and rejections.

   • Vera ID: ID of the approval record.

   • Vera Rejection Reason: The cause for the rejection entered in the Reject Selected Entity dialog.

Cancel a routed approval

Sometimes you notice an error right after you hit send. Or, maybe you didn't mean to hit send at all. Don't worry, it happens to all of us.

To retract a submitted requirement before it's approved, select the Cancel Approval option from the Actions dropdown to cancel the approval route. This allows you to update and revise any issues before you receive approval or rejection.

To cancel an approval, follow these steps:

1. Wait until the Vera Approval Route field populates. You may need to Reloadthe requirement to see this.

2. Select the Cancel Approval option from the Actions dropdown. The requirement updates to reflect the cancellation, and the Route for Approval option displays in the Actions dropdown.

Revise an approved requirement

You may receive new information that changes how you need to test, or you notice an issue that a previous approver missed. In cases like these, you can restart the approval process with the same requirement.

To revise an approval, select Revise from the Actions dropdown to return the requirement back to the beginning of the approval state.