Test Harnessing using Model Based Testing- A case study in Pharmaceutical Software Development


Pharmaceutical organisations have the challenge to comply with frequent regulatory changes. This calls for frequent changes in the software being used for case processing and regulatory reporting; this is in addition to other changes in their standard operating procedures (SOP) to comply with the regulatory guidelines. It is mandatory for the pharmaceutical organisation to validate the changes in the software to assess the impact on product quality, patient safety and data integrity as per the GxP guidelines. Since all these activities have to be completed in a time bound manner without any compromise on the quality of the software being used, it puts tremendous pressure on their software supplier to deliver quality software to meet these regulatory demands. Hence it is imperative for the software vendor to adopt modern and scientific tools, techniques and methodologies to provide quality software and remain competitive in the market.

Aris Global Software Pvt. Ltd is a leading software provider for pharmaceutical companies with its suite of pharmacovigilance, regulatory, medical information and clinical systems. In this case study we will discuss the testing challenges faced due to frequent upgrades needed in our product for regulatory compliance and feature enhancements. We will demonstrate how a comprehensive Model Based Testing(MBT) approach has helped us in achieving reduced test cycles with enhanced test coverage and improved quality.

Audience take-away:

    • Test methodology for model based testing
    • Business process modelling for business process test design
    • Use of pair-wise technique and decision table for business rule test design
    • Automated test case generation using MBT tool, Smartesting Certifyit™
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Speaker's Profile


Dr. Kailash

Dr. Kailash K P Chanduka,
Testing Shared Service,
Aris Global


Dr. Chanduka has 7  years of research experience and 15 years of  IT industry experience in various roles of leading software companies. Currently, he heads the testing shared services unit at Aris GLobal. The current role and responsibility includes mentoring and leading the team for the development of test automation frameworks, guiding the team for effective test strategy, development of innovative test methodologies for effective and efficient testing, mentoring team for model based testing and development of test models for automated test case generation for the Aris Global suite of products.

Dr. Chanduka has published papers on model based testing in international conferences and peer-reviewed journals. He has been awarded the Technical Innovation Award for the year 2002 during his work at Infosys Technologies Ltd. The award was given for developing a deterministic algorithm for combinatorial testing and its implementation for a leading global investment banker for test harnessing. He has worked as research scientist for Software Engineering and Technology Labs (SETLabs) at Infosys Technologies Ltd to develop methodology for automated generation of test cases from requirement models. He has  lead a team to develop a tool on automated test case generation using novel techniques called behaviour slicing, UML activity diagram and business process diagram. He has filed two patents on the automated test case generation techniques with USPTO during his research work at Infosys Technologies Ltd.

He has worked with Wipro Technologies Ltd as senior test consultant and was leading a team responsible for integrating various in-house test tools for providing  innovative testing solutions.