Document Control
Document Number: OQ-001
Revision: 1.0
Date: 2023-10-01
Prepared By: Validation Team
Approved By: QA Manager
Operational Qualification Protocol for NDDS Process Control System
Objective: To validate the NDDS Process Control System (PLC/SCADA) to ensure it meets the specified requirements for controlling and recording NDDS critical process parameters (CPPs).
Scope: This protocol applies to the NDDS Process Control System used in the production area for the control and recording of NDDS critical parameters.
Responsibilities:
- Validation Team: Execute the qualification protocol and document results.
- QA Team: Review and approve the qualification results.
- IT Team: Ensure system configuration and data integrity checks are implemented.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Availability of user requirements specifications (URS).
- Training of personnel on the NDDS Process Control System.
Equipment Description:
The NDDS Process Control System is a PLC/SCADA based system designed for microfluidics, homogenization, and tangential flow filtration (TFF) processes. It is critical for controlling and recording NDDS CPPs, ensuring data integrity and compliance with regulatory standards.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify access control for audit trail. | Access is restricted to authorized personnel only. | Access log report. |
| OQ-02 | Validate recipe management functionality. | Recipes can be created, modified, and deleted as per user roles. | Recipe management log. |
| OQ-03 | Check data integrity for recorded parameters. | Data is consistent and accurate as per source. | Data integrity report. |
Detailed Test Cases
Test Case OQ-01
Objective: Verify access control for audit trail.
Procedure: Attempt to access the audit trail with various user roles.
Expected Result: Only authorized users can access the audit trail.
Test Case OQ-02
Objective: Validate recipe management functionality.
Procedure: Create, modify, and delete a recipe using authorized user roles.
Expected Result: Actions should be logged and only accessible by authorized users.
Test Case OQ-03
Objective: Check data integrity for recorded parameters.
Procedure: Compare recorded data against source data for accuracy.
Expected Result: All data should match the source without discrepancies.
Deviations
Any deviations from the acceptance criteria must be documented and reviewed by the QA team. Follow-up actions will be determined based on the severity of the deviation.
Approvals
Prepared By: ______________________
Approved By: ______________________