The client is one of the largest corporations in medical devices, pharmaceutical and consumer products development.
Business Needs and Objectives
The client sought to expedite their validation effort while maintaining standards compliance. This was part of the client’s strategic goal of reducing the development life-cycle for its medical devices.
The QualiTest Solution
QualiTest introduced Exploratory Test Validation (ETV), a complete test validation solution based on the Exploratory Testing approach. After a careful evaluation process, the QualiTest ETV solution was selected as the main validation approach for the project.
ETV is based on Session Based Test Management (SBTM) and industry validation standards (FDA, EMA, IEC). SBTM is a formalized approach for managing Exploratory Testing in which test design and test execution are combined into a structured and continuous process. SBTM was developed by James Bach for Microsoft and Hewlett-Packard in 1999 in response to the demand for a high speed yet legally defensible test process.
QualiTest partnered with James Bach on this project to ensure the successful implementation of the ETV solution. James Bach* is personally involved in mentoring and monitoring QualiTest’s testing team.
As part of the ETV solution, QualiTest implemented its Validation Management Tool (VMT). VMT is a comprehensive web collaboration platform facilitating all aspects of the validation process. VMT covers every step of the validation process including: feature specifications, requirements management, test protocol planning, scheduling, execution, defect management, defect resolution and risk management.
Key VMT features:
- Validation analytics dashboard
- End-to-end traceability management
- Support of both scripted and exploratory testing
- Generating reports for direct regulatory submission
- Role based collaboration
- Automated workflow
- Multiple test platform management
- Built-in Issue tracking
- CFR 21 part 11 compliance
About James Bach
*James Bach is a well-known QA and testing consultant, author and testing expert. Bach is recognized as the father of ET and for 20 years has been at the forefront of ET approach development with colleagues at the context driven school of testing.