Bionuclear Process Analytical Tools

Client

The client is Advanced Internet and Emergent Systems Centre, part of the University of Liverpool.

Description of the Project

The purpose of this project was to develop a BioPAT Collaborative Knowledge Repository (CKR). This tool is intended for using by the BioPAT project consortium. The BioPAT project intents to use Process Analytical Technology (PAT), which was aligned to the DTI’s call for research proposals entitled "Improved tools for Bioprocessing" program, to deliver improvements to new and current bioprocesses for therapeutic antibodies (IgG) from early stages of development, aiding technology transfer, reducing batch failures and demonstrating process consistency through the life cycle of the product, hence delivering robust, efficient and optimised commercial processes.

The BioPAT project consisted of three integrated components:

• CKR Database;
• CKR Data Visualization and Manipulation Tool (DVMT);
• CKR Analysis Tool.

The project was performed on the basis of fixed price model.

Organizational Management and Cooperation with Customer

• Testing activities were performed on the Qulix Systems’s territory, acceptance testing passed at AiMeS at the end of the project;
• Rational ClearQuest was used to provide change management process, the product is installed locally and the customer had access to it through the Web;
• LoadRunner was used to create and run performance, load, volume and stability testing;
• Functional testing process was based on the black-box testing methodology that supposes of using technical requirements and system specifications and do not requires of deep knowledge of business and technical system internals;
• After the every build testing AiMeS management team was provided with actual test results, known defects and enhancements which were submitted in the ClearQuest database;
• Testing of the software product was separated onto several stages:
  • Test documentation design – Test cases, based on the Functional and Design specifications; Test cases covered testing of 3 modules: CKR Database, CKR DVMT and CKR Analysis Tool.
  • Functional testing which was based on the designed Test documentation. Every build passed through Smoke, Regression, and new features testing. Generally we performed Functional, Usability, Security, Localization, Configuration and Installation tests during the system development.
  • Performance and load testing was performed regularly starting from the first stable version and till the end of project.

Benefits for the Customer

• The system was delivered on time with high quality;
• The customer received the complete set of quality control documentation and scripts for test automation to be used for possible further system modification;
• All expenses associated with the testing processes building and managing were assumed by Qulix Systems;
• The customer didn’t need to hire and train additional employees and to buy licenses for test automation tool;
• According to the customer acknowledgement they saved nearly 34% of budget planned for quality control activities.