Computer systems validation: managing traceability in Jira

Without the right tools in place, traceability matrices can easily bring a project to the brink of collapse. Still today there are project managers who delay moving to production for a significant length of time while they put together a traceability matrix for the validation report. 

Fortunately, with the addition of appropriate plugins, Jira provides an excellent solution. Using it to manage your specifications and tests will eliminate the need for tedious manual work by integrating traceability throughout every stage of the project. As user requirements and other elements emerge and evolve, the traceability will be updated, and a fully up-to-date traceability matrix will be available at any time.

What are the elements of a traceability matrix?

1. You analyse requirements to identify risks, and these risks needs to be mitigated. Those mitigations then become requirements. So a requirement will be connected with a related risk and that risk will be related to another requirement that mitigates it. When these links are all clearly documented we can describe this as bi-directional traceability.
2. Functional specifications are prescriptive and specific. In the case of configurable computer system, configuration specifications will often be dictated by functional specifications. Each functional specification has to be triggered by, or traceable to a requirement.
3. Tests are how you demonstrate that the system meets the specifications. You first need to plan the tests, and the plan will only be complete when all functional specifications can be traced down to tests. 
4. The system can be declared validated only when there has been a successful test run for each test.

Choosing the right technology to manage traceability

Anyone who has ever tried using Excel to manage traceability can testify that it doesn't scale well and is very tedious to use, even for the smallest project.

A good tool to manage traceability will:

1. be seamlessly integrated with your specification management - this eliminates duplication of effort
2. offer strong reporting capability, showing the different levels of traceability in a clear forrnat
3. be flexible, allowing you to define the report layout and content
4. make it easy to spot traceability gaps

Managing traceability in Jira 

Jira comes, out of the box, with the capability to link issues. So, if you have a requirement and a functional specification set up as Jira issues, you just need to link them to establish traceability.

It's a good idea to use meaningful link names, like 'traceability link', to differentiate traceability links from other links that may exist between issues. 

There are many add-ons available that provide powerful features to extend Jira's core issue-linking capability. The additional capabilities available range from auto-calculating coverage status to visually displaying the hierarchy of links and reporting.

Here are some concrete examples:

1. Links Hierarchy for Jira & Agile provides a visual tree of multilevel links for each issue, so you can see the complete path from requirement to test for each and every issue.
2. Xray for Jira and Test Management for Jira are both test management suites that provide clear visibility of test coverage and offer several convenient traceability views.
3. Test Management for Jira creates traceability reports, which can be easily exported.
4. Xporter for Jira and PDF View for Jira are both report generation tools, which you can use to export traceability reports in almost any layout you want.

This article is part of our 'computer system validation and Jira' series; it is co-authored with Markus Roemer.

Join our London Event on the 3rd. October 2018: Practical Solutions in Computer Systems Validation (CSV) and Software Development Life Cycle for GXP & MedDev