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AUTOMATION & TESTING

Installation & Operational Qualification of Automated In-Circuit Test Equipment

A mid-sized medical device electronics manufacturer required documented evidence of proper installation, intended operation, and compliance with 21 CFR Part 820 and ISO 13485:2016 for a newly installed Medalist i3070 In-Circuit Test (ICT) system supporting Class II medical devices. Key challenges included validating complex hardware and software configurations, ensuring electronic data integrity, controlling system access, and demonstrating compliance with FDA and ISO requirements.

Project Metrics

Outcome VerifiedZero Deviations
Test Pass Rate100%
Diagnostic TestsAll Passed
01

Problem Definition

A mid-sized medical device electronics manufacturer required documented evidence of proper installation, intended operation, and compliance with 21 CFR Part 820 and ISO 13485:2016 for a newly installed Medalist i3070 In-Circuit Test (ICT) system supporting Class II medical devices. Key challenges included validating complex hardware and software configurations, ensuring electronic data integrity, controlling system access, and demonstrating compliance with FDA and ISO requirements.

02

System Constraints

21 CFR Part 820 (FDA Quality System Regulation)
ISO 13485:2016 (Medical Devices Quality Management Systems)
Class II medical device manufacturing requirements
Electronic data integrity and audit trail requirements
Access control and user permission validation
03

Engineering Decisions

Applied structured, risk-based IQ/OQ methodology

Verified installation parameters and environmental conditions

Validated operational functionality across multiple test programs

Confirmed diagnostic capabilities and measurement accuracy

Verified data handling procedures and electronic records

Validated access control mechanisms and user permissions

04

Validation Strategy

  • All IQ and OQ test cases completed with zero unresolved deviations
  • Diagnostic testing detected no errors
  • Data integrity and access controls verified
  • Measurement accuracy within specified tolerances
  • Electronic records showed proper audit trail functionality
  • Complete traceability and objective evidence documented
05

Risk & Mitigation

Identified critical control points: measurement accuracy, data integrity, access control
Mitigation:
Implemented redundant verification of calibration status
Mitigation:
Required electronic signature for critical operations
Mitigation:
Established role-based access permissions
Mitigation:
All identified risks addressed through specific test cases
Mitigation:
06

Final Outcome

Successfully qualified the Medalist i3070 ICT system with complete validation documentation suitable for regulatory inspection. The system demonstrated consistent performance with zero unresolved deviations, providing confidence in its ability to detect PCBA defects reliably.

Outcome VerifiedZero Deviations
Test Pass Rate100%
Diagnostic TestsAll Passed