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.
- 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™