01
Problem
A new ICT platform required formal qualification before use in regulated production, including hardware installation, safety verification, software setup, and calibration traceability.
02
Constraints
- Validation had to satisfy quality-system expectations for production test equipment.
- Calibration status of power supplies and measurement subsystems had to be verified.
- Equipment history records required complete traceability.
- The documentation package needed to be reusable for future ICT deployments.
03
Engineering Decisions
- Created an IOQ protocol covering installation, operational checks, software, safety, and environment.
- Mapped equipment functions to documented acceptance criteria.
- Captured calibration and configuration status as controlled evidence.
- Structured the package for audit readability.
04
Validation
- Performed installation verification for equipment, utilities, and environment.
- Executed operational checks against acceptance criteria.
- Reviewed calibration, software version, and documentation completeness.
05
Risk & Mitigation
- Incomplete configuration records could compromise release; mitigated through equipment-history documentation.
- Calibration gaps could affect acceptance decisions; mitigated through calibration-status verification.
- Unclear procedure ownership could delay release; mitigated through controlled approval workflow.
06
Outcome
The ICT platform was qualified for cGMP production use with a complete evidence package supporting equipment release.