From Requirements to Verification: Traceability in Test Management

Requirements are the backbone of every software project. They define what needs to be built, why it matters and how its success will be measured. When it comes to the highly regulated industries, such as pharmaceuticals, medical devices, or finance - the stakes for requirements are even higher. In these areas, they act not only as guidelines for developers, but as formal evidence of compliance as well. If requirements are poorly defined or not properly verified, the cost of failure can be high, both in financial and reputational terms.

The GAMP 5 Life Cycle Approach

The GAMP 5 framework (Good Automated Manufacturing Practice) highlights the importance of requirements within a life cycle approach. One of its key diagrams - Specification, Design, and Verification - illustrates how requirements move through each stage of system development:

• Specification: defining what the system must do.
  
  
• Design: translating specifications into a technical solution.
  
  
• Verification: ensuring the design meets the original requirements through testing.
  
  

The Specification, Design and Verification process in GAMP 5 [1].

This model emphasizes that traceability can’t beoptional. It is the link that ensures every requirement is addressed in design and verified through tests. Without this closed loop, organizations cannot demonstrate that systems are fit for purpose or compliant with standards.

Requirements in Agile and Jira

Modern software development often follows Agile principles, where requirements are expressed more dynamically than in traditional models. Instead of large requirement documents, Agile teams capture business needs in tools like Jira. A software like this, dictates a specific structure, where: 

• Epics represent broad goals or business capabilities.
  
  
• Stories break these goals into actionable tasks, focusing on user value.
  
  

This arrangementsupports rapid delivery, however it also introduces challenges as byproducts. With the growing number of Epics and Stories,, teams may lose visibility into whether each requirement is being tested and validated. In such cases, requirement traceability becomes particularly critical.

Traceability in GAMP 5 Framework

GAMP 5 underlines that every requirement, whether functional, non-functional or regulatory,should be linked to verification activities. Traceability matrices, coverage analysis and impact assessments - they all stem from this principle.

From a tester’s perspective, traceability answers these fundamental questions:

• Has every requirement been tested?
  
  
• Which tests prove compliance with specific requirements?
  
  
• What is the impact of changing or removing a requirement?
  
  
• If a test fails, which requirement is at risk?
  
  

By providing answers to these questions, traceability not only safeguards compliance, but also builds confidence in the overall quality of the system.

The Role of Traceability Reports in Jira

While Jira provides a flexible structure for managing Epics and Stories, it does not natively deliver the depth of traceability needed for professional test management. Taking this aspect into consideration, dedicated solutions for Jira are the answers to the issue. Appsvio Test Management (ATM) introduces structured entities such as Test Cases, Test Executions and Defects, which are natively integrated as Jira work items.. As it’s built on Atlassian Forge, ATM is the only Jira test management app with the Runs on Atlassian badge, ensuring security and reliability within Atlassian’s infrastructure.

Most importantly, ATM includes a Traceability Report. This report connects requirements, tests and executions, providing a clear overview of project health. QA teams can immediately see the test coverage, identify any gaps and assess the impact of changes. In practice, this means that the critical questions raised by GAMP 5 can be answered directly in Jira, without external spreadsheets or disconnected tools.

Traceability report in ATM easily gives users an oversight to every link between requirements, test cases, executions and defects.

Why Does This Matter to the QA?

To summarize, traceability is more than a compliance checkbox. It supports better decision-making by providing insight into project health. Teams can quickly identify gaps in testing, assess the impact of changes and demonstrate accountability to stakeholders.

By combining the structured perspective of GAMP 5 with Agile practices in Jira and leveraging tools like ATM, organizations can achieve both compliance and agility. The result is software that not only meets user expectations but also passes the rigorous test of regulatory scrutiny.

Exceed compliance standards, don’t just meet them. Take the next step in your software development journey and get started with ATM now.

[1] - Wyn Sion, GAMP 5 - Enabling Innovation, Pharmaceutical Engineering 28, no. 1(January/ February 2008), p. 3. 

https://ispe.org/sites/default/files/attachments/public/Jan-Feb-2008.pdf