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Configure Jira Integration for Design Controls
Configure Jira Integration for Design Controls

Instructions for Jira Administrators to configure integration with Design Controls

Written by Lydia Olu-Harding
Updated over a week ago

Qualio Design Controls is used by companies creating medical device software to structure, strengthen and centralize their software development and quality activities.

This integration will require a Jira Administrator to:

Create an API Token

Create an API token from your Atlassian account. We highly recommend creating or using a service user that belongs to a group, rather than an individual. This will prevent connectivity issues if an individual leaves.

  1. Click Create API token.

  2. From the dialog that appears, enter a memorable and concise Label for your token and click Create.

  3. Click Copy to clipboard, then past the token to your script, or elsewhere to save.

Please note, for security reasons it isn’t possible to view the token after closing the creation dialog; if necessary, create a new token. You should store the token securely, just as you would for any password.

Next, you will need to share the following with Qualio securely:

  • Host Domain (e.g.:

  • The API token

  • The email address associated with the account that created the API token

  • Jira Project Name

  • Jira Project Code

  • Product name (if different from the project name)

To share securely, you can use a tool such as Secret Share.

Create Issue Types and Add to Project

Project Type

When creating a new project, you’ll need to select a company-managed project. This enables you to create custom issue types, and custom fields as required by our setup.

The integration is configured to pull from predefined Jira Issue types; Epic, Story, Sub-task, and if using Jira for test case management, two custom issue types.

Custom Issue Types - These steps can be skipped if you are using Xray or Testrails

You will need to create two custom issue types in Jira: Test Case and Test Result. This step can be skipped if you are doing Test case and Test Evidence outside of Jira. We currently support Xray and Testrails for integration with test management systems.

  1. Browse to the JIRA Settings menu and select Issues.

    This will take you to the Issue Types screen.

  2. Click the Add Issue Type button. In the below modal, enter the name “Test Case” and select “Standard Issue Type”. The Description field is optional. Then click the Add button to proceed.

  3. Add another Issue Type for Test Result. Click the Add Issue Type button on the Issue Types screen. In the modal window, enter the name “Test Result” and select the “Sub-Task Issue Type”.

    Add Custom Issue Types to Project

  4. Add Issue Types to Project from the Issue Types Schemes screen.

  5. Find the project you want to add the Issue Types to, and click on Edit.

  6. Modify the issue type scheme for the project by dragging the issue types Test Case and Test Evidence from the Available Issue Types to the Current Scheme panel, then click Save.

    You have now completed configuration of the required issue types. This will allow for successful data sync between Jira and Qualio for product requirements and associated test cases. The integtration will pull data from the following Jira issue types: Epic, Story, Sub-task, Test Case and Test Result.

Create a Custom Field for Test Result Status

Each test result item will need to have a Passed, Failed or Blocked status applied. Therefore, a custom field in the Test Result custom issue type will need to be created to allow Qualio to capture the test result.

  1. In the Settings Issues screen, go to Custom Fields, found on the navigation left-side panel.

  2. Click on Create custom field button.

  3. In the modal presented, choose ‘Select List (single choice)’ option, then click Next.

  4. Enter the name “Test Result”. Then add three options: "Passed", "Failed" and "Blocked". The description field is optional. Then click Create.

  5. Next, add the custom field to our Test Result issue type. In the list of custom fields select “Test Result”, click “Edit details”

  6. Click on “Edit Configuration” (visible on the below screen)

  7. Select "Test Result" under "Applicable issue types"

Jira-Design Controls Field Mappings

Data pulled from the Epic, Story, Sub-Tasks, Test Case, and Test Result issue types in Jira, will map to specific fields in Design Controls.

Jira Field

Design Control Field





Issue Status


Key (e.g. JSP-1)


Test Result

Test Result Status

Example Field Mapping (Jira Issue Type - Design Controls Equivalent)

Level 1 Requirement (Epic - User Need)

Level 2 Requirement (Story - Design Input)

Level 3 Requirement (Sub-task - Design Output)

Level 1 Test Case (Test Case - Validation)

Level 2 Test Case (Test Case - Verification)

Frequently Asked Questions

  1. What direction will the data flow?

    • The data flows in one direction from Jira to Qualio

  2. How often is data pulled from Jira?

    • Data is pulled across from Jira every five minutes (once the integration has been enabled)

  3. What data is pulled across?

    • All Epic, Story, Sub-task, Test Case & Test Result issues in the project(s) specified irrespective of when they were/are created. If created prior to enabling the integration, they will get pulled across.

  4. Can I integrate with multiple instances of Jira?

    • We can only integrate one instance of Qualio with one instance of Jira

  5. Can I change my host domain?

    • Jira allows for the host domain to be modified however making this change after the integration is enabled will prevent the integration from pulling data from the project(s) specified.

  6. What issue types can I pull data from?

    • The out-of-the-box integration pulls data from the following Issues & Sub-tasks;

      • Epic,

      • Story,

      • Sub-task,

      • Test Case (Custom Issue Type),

      • Test Result (Custom Sub-task)

        • Test Result (Custom Field)

  7. Can I change my issue labels?

    • It is possible to enable custom issue/sub-task labels in Jira but this information needs to be specifed at the outset. Changing these labels after the integration is enabled will prevent the integration from pulling data from the project(s) specified.

    • Field mapping documentation is required as part of the computer-system-validation.

    • If the labels such as “Epic” & “Sub-tasks” are modified and the field mapping in the validation documentation specifies “Epic” & “Sub-tasks”, both the integration and the validation documents will have to be updated.

  8. Can I include images in my requirements and/or test cases?

    • Jira allows for images to be input to issues and sub-tasks but image data is not pulled across to Qualio

  9. What actions are captured as changes in Design Controls?

    • Modifications to the summary field, description field, issue links field or issue status of approved items is flagged as "CHANGED" in Qualio

    • If an item that is approved in Qualio is deleted in Jira or transfered to a non-integrated Jira project, that is flaged as "DELETED" in Qualio

    • When files are attached or when attached files are deleted from approved items, this modification is flagged as "CHANGED" in Qualio.

    • See the Review Workflow article for details about these statuses

  10. Can I use the Epic link?

    • Our integration relies on the issue links (relates to). You may use the Epic link in Jira but it won't enable traceability of requirements in Qualio

  11. Can I link to multiple issues/subtasks?

    • Level 1 test cases can only be linked to a level 1 requirement (linking to a level 2 requirement as well, will prevent that data from getting pulled into Qualio)

  12. In my Jira settings can I use a language other than English?

    • The off-the-shelf integration is configured to identify and pull data from the labels listed above (see Question #6), which are in English.

    • It is possible to use alternative labels (including labels in languages other than English) but such customization will add time to the implementation process

Next Steps

Now that configuration of Design Controls with Jira integration is complete, you can now begin creating requirements in Jira.

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