Document Number: IQ-BCS-001
Version: 1.0
Date: 2023-10-05
Prepared By: [Your Name]
Reviewed By: [Reviewer Name]
Approved By: [Approver Name]
Installation Qualification Protocol for Barcode Scanner in Solid Dosage Form Production
Objective: To verify that the Barcode Scanner is installed correctly and functions as intended to ensure identity verification and traceability in the Solid Dosage Form production area.
Scope: This protocol applies to the Installation Qualification of the Barcode Scanner used in the Production/Dispensing area for Solid Dosage Form manufacturing.
Responsibilities:
- Validation Team: Prepare and execute the IQ protocol.
- Quality Assurance: Review and approve the protocol and results.
- IT Support: Ensure technical support for software and hardware.
Prerequisites:
- Completion of equipment installation by qualified personnel.
- Availability of relevant documentation (URS, SOPs).
- Training of personnel on the use of the Barcode Scanner.
Equipment Description: The Barcode Scanner is a GMP-compliant instrument used for identity verification and traceability of products in the Solid Dosage Form production area. It captures scan accuracy data and maintains an audit trail in compliance with URS Annex 11 and 21 CFR 11.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation according to manufacturer’s specifications. | Installation meets all specifications. | Installation checklist and photographs. |
| IQ-02 | Check connectivity to the system. | Scanner connects without errors. | Connection test results. |
| IQ-03 | Perform scan accuracy test. | Accuracy ≥ 99%. | Scan accuracy report. |
| IQ-04 | Verify audit trail functionality. | Audit trail captures all scans. | Audit trail log. |
Detailed Test Cases:
- Test Case IQ-01: Confirm all components installed as per the installation guide.
- Test Case IQ-02: Check the scanner’s connection to the main system by running a connectivity test.
- Test Case IQ-03: Conduct a series of scans on known barcodes and calculate the accuracy percentage.
- Test Case IQ-04: Scan products and verify that each scan is logged in the audit trail with timestamps and user IDs.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A root cause analysis should be performed, and corrective actions must be implemented.
Approvals:
- Prepared By: ______________________
- Reviewed By: ______________________
- Approved By: ______________________
Data Integrity Checks:
- Ensure that all scans are timestamped and linked to the user ID.
- Regularly review audit trails for any unauthorized access or discrepancies.
- Perform periodic validation checks to ensure ongoing compliance with acceptance criteria.