Document Control:
Document ID: DQ-NDDS-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Design Qualification Protocol for NDDS Process Control System
Meta Description: This document outlines the Design Qualification Protocol for the NDDS Process Control System, ensuring compliance with critical data integrity requirements.
Tags: Equipment Validation, NDDS, CSV, Data Integrity, Design Qualification
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the NDDS Process Control System meets the specified requirements for controlling and recording NDDS Critical Process Parameters (CPPs) while ensuring data integrity and compliance with regulatory standards.
Scope
This protocol applies to the NDDS Process Control System utilized in the production area for the control and recording of NDDS CPPs. It encompasses the validation of software/system functionalities relevant to data integrity and compliance with 21 CFR Part 11.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- IT Department: Responsible for maintaining the system and ensuring its compliance with data integrity requirements.
Prerequisites
- Completion of User Requirements Specification (URS).
- Installation and configuration of the NDDS Process Control System.
- Training of personnel on system operation and data integrity principles.
Equipment Description
The NDDS Process Control System is a software/system designed for controlling and recording NDDS Critical Process Parameters (CPPs). It includes functionalities for audit trail access control, recipe management, and data integrity measures.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify audit trail access control functionality. | Access is restricted to authorized personnel only. | Access logs and user permissions report. |
| T2 | Check recipe management functionality. | System allows creation, modification, and deletion of recipes with proper logging. | Recipe log and modification history. |
| T3 | Assess data integrity measures. | Data is captured accurately and stored securely. | Data integrity audit report. |
Detailed Test Cases
Test Case T1: Audit Trail Access Control
Objective: To verify that only authorized personnel can access the audit trail.
Steps:
- Log in as an authorized user.
- Attempt to access the audit trail.
- Log out and attempt to access the audit trail as an unauthorized user.
Expected Result: Authorized users can access the audit trail; unauthorized users cannot.
Test Case T2: Recipe Management
Objective: To verify the functionality of recipe creation, modification, and deletion.
Steps:
- Create a new recipe.
- Modify the created recipe.
- Delete the recipe.
Expected Result: All actions are logged with timestamps and user IDs.
Test Case T3: Data Integrity
Objective: To ensure data is accurately captured and stored.
Steps:
- Run a process controlled by the system.
- Verify data captured during the process.
Expected Result: Captured data matches expected results and is stored securely.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on the validation process. A corrective action plan should be established as necessary.
Approvals
This protocol requires approval from the following individuals:
- Validation Team Lead: ____________________ Date: _____________
- Quality Assurance Manager: _______________ Date: _____________
- IT Department Head: _____________________ Date: _____________