Document Control:
Document Number: DQ-QC-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Name]
Approval Date: YYYY-MM-DD
Design Qualification Protocol for Conductivity Meter in QC Laboratory
Objective: To ensure that the Conductivity Meter used in the QC Laboratory meets all specified requirements and performs reliably for conductivity measurement.
Scope: This protocol applies to the Design Qualification of the Conductivity Meter situated in the QC Laboratory, addressing its criticality and impact on product quality.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Ensures compliance with regulatory standards and reviews validation documentation.
- Laboratory Personnel: Operates the Conductivity Meter and assists in testing.
Prerequisites:
- Completion of User Requirements Specification (URS).
- Installation Qualification (IQ) must be completed.
- Training of personnel on the operation of the Conductivity Meter.
Equipment Description:
The Conductivity Meter is an instrument used for measuring the electrical conductivity of solutions in the QC Laboratory. It is critical for ensuring product quality and compliance with specifications.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Perform accuracy calibration using standard solutions. | Results must fall within ±0.5 μS/cm of the standard. | Calibration report and audit trail. |
| T2 | Verify audit trail functionality. | Audit trail must document all changes and user actions. | Audit trail log review. |
Detailed Test Cases:
- Test Case 1: Accuracy Calibration
- Prepare standard conductivity solutions.
- Calibrate the Conductivity Meter.
- Document results and compare against acceptance criteria.
- Test Case 2: Audit Trail Verification
- Simulate user actions on the Conductivity Meter.
- Review the generated audit trail.
- Ensure all actions are logged correctly.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. Corrective actions should be initiated as necessary.
Approvals:
____________________
Validation Team Lead
____________________
Quality Assurance Manager
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