Validation determines if a method is suitable for its intended use and establishes performance characteristics, while verification confirms that a lab can achieve the validated performance using its specific instruments and workflows.
Why it matters
- Regulatory Compliance: Ensures adherence to regulatory standards and guidelines, particularly in clinical settings.
- Quality Assurance: Maintains high-quality testing processes, which is critical for patient safety and treatment decisions.
- Resource Optimization: Helps in efficiently allocating resources by clearly defining roles and responsibilities in testing processes.
- Risk Management: Identifies potential risks associated with test performance, allowing for proactive mitigation strategies.
- Accreditation Alignment: Supports compliance with accreditation bodies’ expectations regarding laboratory practices.
How to apply
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Define Validation and Verification:
- Clearly outline the definitions and differences between validation and verification within your lab’s quality management system.
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Establish Protocols:
- Develop detailed protocols for both validation and verification processes, including methodologies, acceptance criteria, and documentation requirements.
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Conduct Validation:
- Perform validation when developing or significantly modifying laboratory-developed tests, assessing accuracy, precision, sensitivity, specificity, and reportable range.
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Implement Verification:
- Adopt verification processes for already-validated or FDA-cleared methods to confirm performance in your lab environment, utilizing local instruments and workflows.
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Document Everything:
- Maintain thorough documentation of all validation and verification activities, including results, methodologies, and any deviations from the planned protocols.
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Monitor Ongoing Performance:
- Establish a system for continuous quality monitoring, including quality control measures, proficiency testing, and stability checks.
Metrics to track
- Performance Characteristics: Track accuracy, precision, sensitivity, specificity, and reportable range for tests.
- Compliance Rates: Monitor adherence to established protocols and acceptance criteria.
- Error Rates: Keep records of any discrepancies or failures during validation and verification processes.
- Turnaround Time: Measure the time taken to complete validation and verification, aiming for efficiency without compromising quality.
- Quality Control Results: Regularly assess quality control data to ensure ongoing test performance aligns with validated parameters.
Pitfalls
- Lack of Clarity: Failing to clearly define validation and verification can lead to confusion and miscommunication among staff.
- Inadequate Documentation: Not documenting processes thoroughly can result in regulatory non-compliance and loss of accreditation.
- Neglecting Ongoing Monitoring: Disregarding the need for continuous quality checks can lead to undetected performance issues over time.
- Overlooking Training: Insufficient training for staff on validation and verification processes can compromise test accuracy and reliability.
- Assuming Similarity: Assuming that a validated method will perform the same in every lab environment without proper verification can lead to erroneous results.
Key takeaway: Clear definitions and robust processes for validation and verification are essential for maintaining high-quality standards in genomics laboratories.