Validation Exercise for a Non-Destructive Inspection Device for Blister Pack

Abstract

This project focuses on the validation exercise of a non-destructive vision scan system for blister pack leak detection within a regulated environment. The methodology included a systematic approach, following the System Life Cycle for validation equipment. Collaboration with the team facilitated the delineation of project objectives and success criteria, ensuring alignment with regulatory requirements. A Risk-Based Approach guided validation strategy development, optimizing resource allocation and validation efficiency. The qualification phase involved testing and documentation, verifying system components and functionalities to ensure operational suitability. The project highlights the importance of thorough planning, risk management, and stakeholder collaboration in achieving validation success within regulated environments. The lessons learned from this project will inform future validation efforts, contributing to continuous improvement and adherence to best practices in validation methodology. Key Terms ⎯ Decay test, Gross test, Leak Detection, Validation of Equipment.