21 CFR and Computer System Validation
1. Key Parts of 21 CFR Relevant to CSV
21 CFR Part 11:
- Governs electronic records and electronic signatures.
- Ensures system integrity, security, and traceability.
Key aspects include:
- Validation of systems to ensure accuracy, reliability, and consistency.
- Audit trails to track changes and user actions.
- Controls for electronic signatures equivalent to handwritten signatures.
21 CFR Part 820:
- Applies to Quality System Regulations (QSR) for medical devices.
- Requires validation of automated systems used in the design, manufacture, and testing of medical devices.
21 CFR Part 211:
- Governs manufacturing practices for pharmaceuticals.
- Includes requirements for automated systems involved in drug production, quality testing, and storage.
2. Applying 21 CFR in CSV
Planning Phase
System Requirements Definition:
- Clearly define user and functional requirements.
- Align these with applicable 21 CFR parts (e.g., Part 11 compliance).
Risk Assessment:
- Identify risks associated with the computerized system and its impact on product quality and patient safety.
- Prioritize validation activities based on risk.
Validation Activities
Validation Plan:
- Define the scope, objectives, and responsibilities for validation.
- Include all deliverables (e.g., IQ, OQ, PQ protocols).
Design Qualification (DQ):
- Confirm the system design meets regulatory and business requirements.
Installation Qualification (IQ):
- Verify proper installation of hardware and software components.
Operational Qualification (OQ):
- Test the system’s operational functionality against specifications.
Performance Qualification (PQ):
- Ensure the system consistently performs under real-world conditions.
Documentation and Traceability
- Maintain comprehensive documentation of all validation activities.
- Ensure traceability from system requirements to test cases and results.
Control Measures
Change Management:
- Control changes to validated systems through a formal change management process.
Access Controls:
- Limit system access to authorized personnel.
Audit Trails:
- Ensure that the system logs all critical actions and changes.
Periodic Review
- Regularly review and revalidate systems to ensure ongoing compliance with 21 CFR.
3. Practical Tips for 21 CFR Compliance in CSV
- Use a risk-based approach for validation efforts.
- Leverage tools and templates to streamline documentation.
- Train personnel on 21 CFR requirements and CSV principles.
- Conduct regular internal audits to identify and address compliance gaps.
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Resource Person: Siman Reddy Pondugula