Design Qualification Protocol for Serialization and Aggregation Software
Document Number: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Author Name]
Approved by: [Approver Name]
Objective
The objective of this Design Qualification (DQ) protocol is to verify that the Serialization and Aggregation System meets the specified requirements and complies with applicable regulatory standards, ensuring proper functionality for tracking and tracing solid dosage forms.
Scope
This DQ protocol applies to the Serialization and Aggregation System utilized in the packaging area for solid dosage forms. It encompasses the assessment of software functionalities related to audit trail, access control, and data integrity.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Ensures compliance with regulatory requirements and reviews documentation.
- IT Department: Supports software installation and configuration.
Prerequisites
- Completion of User Requirements Specification (URS).
- Installation of the Serialization and Aggregation System.
- Access to necessary documentation and resources.
Equipment Description
The Serialization and Aggregation System is a software solution designed to manage the serialization and aggregation of solid dosage forms, enabling effective tracking and tracing throughout the supply chain. It incorporates functionalities for audit trails, access control, and data integrity.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T001 | Verify audit trail functionality. | Audit trail is complete and accessible. | Audit trail report. |
| T002 | Check access control settings. | Access control is restricted to authorized personnel. | Access control configuration report. |
| T003 | Evaluate data integrity checks. | Data integrity checks confirm no unauthorized changes. | Data integrity report. |
Detailed Test Cases
Test Case T001: Audit Trail Functionality
Objective: To ensure that the audit trail captures all necessary events.
Procedure: Access the audit trail and review logged events for completeness.
Acceptance Criteria: All events related to data access and modifications are logged.
Evidence: Generate and review the audit trail report.
Test Case T002: Access Control Settings
Objective: To confirm that access to the system is restricted appropriately.
Procedure: Review user roles and permissions in the system.
Acceptance Criteria: Only authorized users can access critical functions.
Evidence: Document user roles and permissions settings.
Test Case T003: Data Integrity Checks
Objective: To validate that data integrity is maintained.
Procedure: Perform checks to ensure no unauthorized changes have occurred.
Acceptance Criteria: Data integrity checks return no errors.
Evidence: Review data integrity check logs.
Deviations
Any deviations from the acceptance criteria must be documented and addressed in accordance with the deviation management process.
Approvals
Prepared by: ____________________ Date: __________
Approved by: ____________________ Date: __________