Document Control Number: PQ-SCADA-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for SCADA System
Objective: The purpose of this Performance Qualification (PQ) Protocol is to validate the SCADA System used for supervisory control and monitoring in the production area, ensuring it meets the specified requirements and regulatory compliance.
Scope: This protocol applies to the SCADA System utilized in the production area for direct product impact, covering all functionalities and critical parameters as outlined in the User Requirement Specification (URS) and regulatory standards.
Responsibilities:
- Validation Team: Responsible for executing and documenting the PQ activities.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- IT Department: Responsible for providing technical support and ensuring system integrity.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary documentation and user manuals.
- Training of personnel on the SCADA System functionalities.
Equipment Description: The SCADA System is a software-based solution designed for supervisory control and monitoring of manufacturing processes, ensuring data integrity and compliance with regulatory standards such as URS Annex11 and 21CFR11.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-SCADA-01 | Verify audit trail functionality by creating, modifying, and deleting records. | All actions are logged with user ID, timestamp, and action description. | Audit trail report. |
| PQ-SCADA-02 | Test alarm functionality by simulating alarm conditions. | All alarms trigger notifications and are logged correctly. | Alarm log report. |
| PQ-SCADA-03 | Check data integrity by reviewing data entry and retrieval processes. | No data corruption or loss occurs during operations. | Data integrity report. |
| PQ-SCADA-04 | Evaluate access control by testing user permissions. | Users can only access functions as per their roles. | Access control report. |
Detailed Test Cases:
- Test Case 1: Create a new record in the SCADA System and verify it appears in the audit trail.
- Test Case 2: Modify an existing record and check the audit trail for the correct log entry.
- Test Case 3: Delete a record and ensure it is logged as deleted in the audit trail.
- Test Case 4: Trigger an alarm condition and verify notification is sent and logged.
- Test Case 5: Attempt unauthorized access to restricted areas and verify access is denied.
Deviations: Any deviations from the acceptance criteria must be documented and reported to the Quality Assurance department for further investigation and resolution.
Approvals:
- Prepared by: [Name, Title, Date]
- Reviewed by: [Name, Title, Date]
- Approved by: [Name, Title, Date]