Test Management for Regulated Industries: A Pharmaceutical Case Study
Published: 27 October 2026
One of India's leading multinational pharmaceutical organisations ran its Computer System Validation, Operational Qualification and Performance Qualification testing without a central test management solution. After assessing our client's testing practices, our team implemented Tricentis qTest as the base for a test management Centre of Excellence. The client now has complete traceability from requirements through to validation evidence.
What you'll learn
- How TTC Global's five-stage approach took a pharmaceutical company to a governed, central test management platform
- How standardisation and role-based training supported qTest adoption among business users, test managers and administrators
- How a searchable repository of historical results supports regression testing, impact assessment and future audits
About This Case Study
As a highly regulated pharmaceutical organisation operating in over 85 countries, our client needed to maintain complete, audit-ready documentation for its CSV, OQ, and PQ activities. Though testing ran across several validation and qualification phases, no common repository held the work. This made it challenging to capture, store and retrieve the evidence that compliance and regulatory audits require.
To improve end-to-end traceability, our client engaged TTC Global to transform their approach to test management. TC Global worked in five stages, starting with a current-state assessment that identified gaps in test governance, reporting, and artefact management. From there, TTC defined a unified test management framework, standardised how teams author test cases, run executions, track defects, capture evidence and report results, and set governance guidelines to meet regulatory and validation requirements.
Now, the company has complete traceability from requirements through to validation evidence and has reused 200+ migrated test cases across testing phases. Learn more about the process in the full case study.
Frequently Asked Questions
Why do regulated industries need centralised test management?
In regulated industries such as healthcare and life sciences, teams must keep complete, audit-ready testing documentation. When test cases, execution results and validation documents are held in different places, those teams struggle to retrieve evidence and trace requirements through to results. A unified test management platform holds the evidence in one place and links requirements to results and defects. Earlier test assets then stay available for reuse.
How can historical test results be reused for regression testing?
In this case study, TTC Global established a repository of historical test scripts, execution results and validation evidence, so the client can reuse earlier work for regression testing and impact assessments. Teams also reused migrated test cases across several testing phases, including system integration testing and user acceptance testing.
What is Tricentis qTest and what is it used for in pharmaceutical testing?
Tricentis qTest is an enterprise test management platform for software testing. In this case study, TTC Global deployed it as the client's single repository for test cases, execution records, validation artefacts and compliance documentation. It also records traceability from requirements through to test results, defects, and validation documents across all testing phases.
How does a central repository make test evidence audit-ready?
A central repository keeps every testing artefact and its supporting evidence in a controlled, traceable place. In this case study, TTC Global introduced standardised processes for test planning, test execution, defect tracking, evidence management and audit reporting, with particular emphasis on computer system validation, operational qualification, performance qualification and user acceptance testing. Complete traceability then supports regulatory audit requirements.