Installation & Operational Qualification of Automated In-Circuit Test Equipment
A medical device manufacturer required documented evidence that the Agilent Medalist i3070 In-Circuit Test (ICT) system was properly installed, calibrated, and operating according to design specifications. The challenge involved validating a complex automated test platform incorporating hardware, software, and electrical safety testing capabilities while ensuring compliance with medical device quality system requirements and maintaining data integrity for production use.
Project Metrics
Tools & Standards
Problem Definition
A medical device manufacturer required documented evidence that the Agilent Medalist i3070 In-Circuit Test (ICT) system was properly installed, calibrated, and operating according to design specifications. The challenge involved validating a complex automated test platform incorporating hardware, software, and electrical safety testing capabilities while ensuring compliance with medical device quality system requirements and maintaining data integrity for production use.
System Constraints
Engineering Decisions
Executed comprehensive IQ protocol covering physical installation, utilities, and environmental conditions
Validated OQ protocol testing system functionality, measurement accuracy, and software operation
Implemented role-based access control with three user levels: Operator, Engineer, Administrator
Established data integrity controls including audit trails, electronic signatures, and backup procedures
Validated test fixture calibration and measurement system accuracy
Confirmed software version control and change management procedures
Tested electrical safety features including ground continuity and insulation resistance
Validation Strategy
- IQ Physical Installation: Verified equipment placement, power requirements, compressed air, and environmental conditions
- IQ Documentation: Confirmed all manuals, procedures, and calibration certificates available
- OQ Functional Testing: Validated test head movement, fixture interface, and measurement accuracy
- OQ Software Validation: Confirmed test program execution, data logging, and report generation
- OQ Access Control: Verified three-level user authentication and permission restrictions
- OQ Data Integrity: Validated audit trails, electronic signatures, and backup/restore procedures
- OQ Calibration: Confirmed measurement system accuracy against NIST-traceable standards
- Zero deviations during IQ/OQ execution
Risk & Mitigation
Final Outcome
Successfully qualified the Agilent Medalist i3070 ICT system for production use with comprehensive IQ/OQ documentation. The validation established documented evidence that the equipment was properly installed, calibrated, and operates in conformance with design specifications and regulatory requirements. Access control and data integrity features were validated to ensure secure operation and audit readiness. The system demonstrated accurate measurement capabilities and reliable test program execution, providing the foundation for production release and ongoing quality assurance.