Installation Qualification Protocol for Device Inspection System in NDDS
Document Number: IQ-DS-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Device Inspection System (Vision/Microscopy) is installed correctly and operates according to specified requirements for inspecting coating defects and dimensions of Drug-Eluting Stents.
Scope
This protocol applies to the Device Inspection System utilized in the Quality Control (QC) and Research & Development (R&D) areas for the inspection of coated devices, specifically Drug-Eluting Stents.
Responsibilities
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the IQ protocol and results.
- Maintenance Team: Responsible for ensuring the equipment is maintained and operational prior to IQ execution.
Prerequisites
- Device Inspection System must be installed according to manufacturer specifications.
- All necessary utilities and connections (power, data) must be verified and operational.
- Personnel must be trained on the operation of the Device Inspection System.
Equipment Description
The Device Inspection System (Vision/Microscopy) is designed to detect coating defects and measure dimensions of Drug-Eluting Stents. It utilizes advanced imaging technology to ensure accurate inspections, critical for product quality.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation against manufacturer specifications. | All components installed as per specifications. | Installation checklist signed by validation team. |
| IQ-02 | Check calibration of detection accuracy. | Calibration within specified limits. | Calibration certificate and records. |
| IQ-03 | Assess data integrity for calibration data. | No discrepancies in calibration data. | Data integrity report. |
Detailed Test Cases
Test Case: IQ-01
Objective: Verify installation against manufacturer specifications.
Procedure: Review installation checklist and confirm all components are installed and functional.
Acceptance Criteria: All components installed as per specifications.
Evidence: Installation checklist signed by validation team.
Test Case: IQ-02
Objective: Check calibration of detection accuracy.
Procedure: Perform calibration checks using standard reference materials.
Acceptance Criteria: Calibration within specified limits.
Evidence: Calibration certificate and records.
Test Case: IQ-03
Objective: Assess data integrity for calibration data.
Procedure: Review calibration records for completeness and accuracy.
Acceptance Criteria: No discrepancies in calibration data.
Evidence: Data integrity report.
Deviations
Any deviations from the established protocol must be documented and approved by Quality Assurance. A root cause analysis should be performed for any critical deviations.
Approvals
_________________________
Validation Team Lead
_________________________
Quality Assurance Representative
_________________________
Maintenance Supervisor