Laboratory Method Validation Verification Checklist
This comprehensive laboratory operations checklist supports regulatory compliance with CLIA (42 CFR Part 493), ISO/IEC 17025, GLP (21 CFR Part 58). Use it to document inspections, verify controls, and address nonconformities before audits or incidents.
- Industry: Laboratory
- Frequency: Monthly
- Estimated Time: 25-45 minutes
- Role: Lab Manager / Quality Lead
- Total Items: 35
- Compliance: CLIA (42 CFR Part 493), ISO/IEC 17025, GLP (21 CFR Part 58), CAP checklists (where applicable)
Documentation & Permits
Confirm required permits, procedures, and records are current and accessible.
- All required procedures and checklists available and in use?
- Controls and equipment in safe working order?
- Notes / observations
- Photo evidence (optional)
- Corrective action required?
Controls & Equipment
Verify critical equipment, safeguards, and monitoring devices are operational.
- All required procedures and checklists available and in use?
- Critical temperature reading
- Notes / observations
- Photo evidence (optional)
- Corrective action required?
Hazard Identification & Exposure Controls
Check that hazards are identified and exposure controls are implemented.
- All required procedures and checklists available and in use?
- Controls and equipment in safe working order?
- Notes / observations
- Photo evidence (optional)
- Corrective action required?
Training & Competency
Confirm required training, competency, and authorizations for the work scope.
- All required procedures and checklists available and in use?
- Controls and equipment in safe working order?
- Notes / observations
- Photo evidence (optional)
- Corrective action required?
Housekeeping & Storage
Verify housekeeping, labeling, segregation, and storage practices reduce risk.
- All required procedures and checklists available and in use?
- Controls and equipment in safe working order?
- Notes / observations
- Photo evidence (optional)
- Corrective action required?
Emergency Preparedness
Confirm emergency equipment, communications, and response procedures are ready.
- All required procedures and checklists available and in use?
- Controls and equipment in safe working order?
- Notes / observations
- Photo evidence (optional)
- Corrective action required?
Corrective Actions & Evidence
Document issues, assign actions, and capture evidence for closure.
- All required procedures and checklists available and in use?
- Controls and equipment in safe working order?
- Notes / observations
- Photo evidence (optional)
- Corrective action required?
Related Quality Control Checklists
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- Laboratory Chemical Hygiene Plan Checklist
- Laboratory Waste Disposal Lab Checklist
- Laboratory Autoclave Verification Checklist
- Laboratory Biosafety Cabinet Certification Checklist
- Laboratory Centrifuge Safety Checklist
- Laboratory Microscope Maintenance Checklist
- Laboratory Data Management Backup Checklist
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Why Use This Laboratory Method Validation Verification Checklist?
This laboratory method validation verification checklist helps laboratory teams maintain compliance and operational excellence. Designed for lab manager / quality lead professionals, this checklist covers 35 critical inspection points across 7 sections. Recommended frequency: monthly.
Ensures compliance with CLIA (42 CFR Part 493), ISO/IEC 17025, GLP (21 CFR Part 58), CAP checklists (where applicable). Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Laboratory Method Validation Verification Checklist cover?
This checklist covers 35 inspection items across 7 sections: Documentation & Permits, Controls & Equipment, Hazard Identification & Exposure Controls, Training & Competency, Housekeeping & Storage, Emergency Preparedness, Corrective Actions & Evidence. It is designed for laboratory operations and compliance.
How often should this checklist be completed?
This checklist should be completed monthly. Each completion takes approximately 25-45 minutes.
Who should use this Laboratory Method Validation Verification Checklist?
This checklist is designed for Lab Manager / Quality Lead professionals in the laboratory industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.