Document Control
Document ID: PQ-NDDS-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Reviewer Name]
Approval Date: YYYY-MM-DD
Performance Qualification Protocol for NDDS Process Control System
Meta Description: This document outlines the Performance Qualification Protocol for the NDDS Process Control System, focusing on CSV and Data Integrity in production.
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the NDDS Process Control System (PLC/SCADA) operates as intended, ensuring control and recording of NDDS Critical Process Parameters (CPPs) while maintaining compliance with regulatory requirements.
Scope
This protocol applies to the NDDS Process Control System used in the production area for controlling and recording NDDS CPPs. The validation will encompass the software/system and its functionalities related to data integrity, audit trails, and recipe management.
Responsibilities
Validation Team: Responsible for executing the PQ protocol and documenting results.
Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
IT Department: Responsible for system configuration and maintenance.
Prerequisites
All relevant documentation, including User Requirement Specifications (URS), Functional Requirement Specifications (FRS), and Design Specifications (DS), must be reviewed and approved prior to executing this protocol.
Equipment Description
The NDDS Process Control System is a PLC/SCADA system designed for the control and recording of NDDS critical process parameters, including microfluidics, homogenization, and tangential flow filtration (TFF). The system ensures compliance with 21 CFR Part 11, focusing on data integrity and audit trails.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-001 | Verify user access controls and audit trails. | Access control is restricted to authorized personnel; audit trails are complete and tamper-proof. | Audit trail logs, user access records. |
| TP-002 | Test recipe management functionality. | Recipes can be created, modified, and deleted according to specified permissions. | Recipe management logs, user permissions documentation. |
| TP-003 | Perform data integrity checks. | Data entries are accurate, complete, and retrievable. | Data integrity reports, sample data entries. |
Detailed Test Cases
Test Case 1: User Access Control
Verify that only authorized users can access the system. Attempt unauthorized access and document the system’s response.
Test Case 2: Audit Trail Verification
Review audit trails for any discrepancies or unauthorized changes. Ensure all changes are logged with timestamps and user IDs.
Test Case 3: Recipe Management
Create a new recipe, modify it, and delete it. Confirm that each action is logged appropriately in the system.
Test Case 4: Data Integrity
Perform checks to ensure data entries are not altered or deleted without proper authorization.
Deviations
Any deviations observed during the execution of this protocol must be documented, including the nature of the deviation, its impact, and corrective actions taken.
Approvals
Prepared By: [Preparer Name] – [Date]
Approved By: [Approver Name] – [Date]