Design Qualification (DQ) in Computerized System Validation (CSV) refers to the documented process that ensures a computerized system is designed according to the required specifications and is suitable for its intended use in regulated environments such as pharmaceutical manufacturing. DQ is one of the critical stages in the validation lifecycle, which includes User Requirements Specifications (URS), Functional Specifications (FS), and Design Specifications (DS). The goal is to ensure the system design complies with regulatory, technical, and business needs.
Key Elements of Design Qualification (DQ) in CSV
1. User Requirements Review (URS):
Ensures the system design meets all user requirements. Confirms that all functionality necessary for the system’s intended purpose is addressed.
2. Functional Specifications (FS) & Detailed Design Specifications (DS):
Reviews detailed software and hardware design to ensure that they align with the URS. Verifies that all system components (e.g., hardware, software, interfaces) meet required technical specifications.
3. Regulatory Compliance:
Confirms that the system is designed to comply with regulatory standards such as GAMP 5, FDA 21 CFR Part 11 (for electronic records and signatures), EU Annex 11, and other applicable guidelines.
4. Data Integrity and Security:
Ensures that system design incorporates robust security measures for protecting data integrity and preventing unauthorized access.
5. System Architecture:
- Assesses the architecture of the system (network, servers, databases) to verify that it supports business needs and regulatory requirements.
- Reviews interfaces between subsystems to ensure seamless integration and data flow.
6. Supplier/Vendor Evaluation:
- Conducts qualification of vendors or suppliers to ensure they can provide products and services that meet validation and regulatory expectations.
- This may include vendor audits, reviewing quality management systems, and assessing technical competencies.
7. Risk Assessment:
- Identifies any potential risks in the system’s design and verifies that they are mitigated through design controls or alternative measures.
- Ensures that risk management practices (such as FMEA or HAZOP) are part of the design process.
8. Traceability Matrix:
A document is created to link requirements from the URS through to design and testing to ensure complete traceability throughout the system’s lifecycle.
9. DQ Deliverables:
- DQ Protocol: A formal document outlining the procedures, requirements, and criteria to be followed during the design qualification process.
- DQ Report: A final report documenting the review, findings, and confirmation that the system design meets all specified requirements.
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