Design Qualification Protocol for Distributed Control System (DCS)
Document Number: DQ-001
Version: 1.0
Date: 2023-10-01
Prepared by: Validation Team
Approved by: Quality Assurance
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Distributed Control System (DCS) is designed and implemented in accordance with user requirements and regulatory standards, particularly URS Annex11 21CFR11.
Scope
This protocol applies to the validation of the DCS used in the production area for process control. It covers all aspects of the system’s design, functionality, and compliance with applicable regulations.
Responsibilities
The Validation Team is responsible for executing the DQ protocol and documenting all findings. Quality Assurance will review and approve the protocol and its outcomes.
Prerequisites
Completion of the User Requirement Specification (URS) and Functional Requirement Specification (FRS) documents.
Equipment Description
The Distributed Control System (DCS) is a computerized system designed for process control in manufacturing. It includes features such as an audit trail, alarms, system integrity checks, and access control mechanisms.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001-01 | Verify audit trail functionality | Audit trail logs all user actions | Audit trail report |
| DQ-001-02 | Check alarms functionality | Alarms trigger correctly and are logged | Alarm log report |
| DQ-001-03 | Test system integrity checks | System integrity checks pass without errors | Integrity check report |
| DQ-001-04 | Validate access control mechanisms | Access control limits user access as per roles | Access control log |
Detailed Test Cases
Test Case DQ-001-01: Verify Audit Trail Functionality
Procedure: Log in as different users and perform various actions. Verify that all actions are recorded in the audit trail.
Acceptance Criteria: All user actions are logged with timestamps and user IDs.
Evidence: Generate and review the audit trail report.
Test Case DQ-001-02: Check Alarms Functionality
Procedure: Simulate alarm conditions and verify that alarms are triggered and logged.
Acceptance Criteria: Alarms must trigger as expected and be recorded in the alarm log.
Evidence: Review the alarm log report.
Test Case DQ-001-03: Test System Integrity Checks
Procedure: Perform integrity checks and verify that the system operates without errors.
Acceptance Criteria: All integrity checks must pass without any errors.
Evidence: Review the integrity check report.
Test Case DQ-001-04: Validate Access Control Mechanisms
Procedure: Attempt to access the system with different user roles and verify access restrictions.
Acceptance Criteria: Access must be granted or denied based on user roles.
Evidence: Review the access control log.
Deviations
Any deviations from the acceptance criteria will be documented and addressed in accordance with the deviation management process.
Approvals
Prepared by: ______________________ Date: ___________
Approved by: ______________________ Date: ___________