Fda Warehouse Audit Checklist Medical Device
Audits reveal operational truth – make sure you’re ready for scrutiny. This Fda Warehouse Audit Checklist Medical Device turns compliance anxiety into systematic confidence. Whether internal or external, scheduled or surprise, this AI-powered tool creates audit-specific preparation that actually works. Stop dreading audits and start using them as improvement catalysts.
Facility Requirements
□ Facility design appropriate
□ Adequate space for operations
□ Temperature/humidity controlled
□ Environmental monitoring active
□ Pest control program effective
□ Cleaning/sanitization procedures
□ Maintenance program documented
□ Security measures adequate
□ Access control enforced
□ Visitor procedures followed
□ Emergency procedures posted
□ Safety equipment available
Quality System
□ Quality manual current
□ SOPs comprehensive
□ Document control effective
□ Change control procedures
□ Training program documented
□ CAPA system functioning
□ Management review conducted
□ Internal audits performed
□ Supplier qualification done
□ Validation/verification complete
□ Risk management implemented
□ Regulatory compliance maintained
Receiving & Inspection
□ Receiving procedures documented
□ Incoming inspection performed
□ Acceptance criteria defined
□ Sampling plans appropriate
□ Non-conforming product controlled
□ Supplier documentation verified
□ Chain of custody maintained
□ Temperature excursions checked
□ Damage assessment done
□ Lot/serial numbers recorded
□ Quarantine procedures followed
□ Release procedures proper
Storage Conditions
□ Storage requirements defined
□ Temperature mapping completed
□ Monitoring systems calibrated
□ Alarm systems functional
□ Backup systems available
□ Cold chain maintained
□ Segregation requirements met
□ FIFO/FEFO practiced
□ Shelf life management active
□ Expired product controlled
□ Product identification clear
□ Location system accurate
Inventory Control
□ Inventory system validated
□ Cycle counting performed
□ Discrepancy investigation done
□ Lot traceability maintained
□ Serial number tracking active
□ Expiration dating controlled
□ Recall procedures ready
□ Product holds managed
□ Consignment inventory tracked
□ Returns processing controlled
□ Destruction procedures documented
□ Annual physical inventory done
Distribution & Shipping
□ Order processing controlled
□ Pick/pack procedures accurate
□ Shipping validation done
□ Temperature monitoring included
□ Package integrity verified
□ Documentation complete
□ Chain of custody maintained
□ Export requirements met
□ Transportation qualified
□ Delivery confirmation obtained
□ Customer complaints tracked
□ Return procedures defined
Computer Systems
□ System validation completed
□ Access control enforced
□ Audit trail functional
□ Data backup performed
□ Disaster recovery tested
□ Change control followed
□ Electronic signatures compliant
□ Data integrity maintained
□ System security adequate
□ User training documented
□ Periodic review conducted
□ Vendor management active
Documentation & Records
□ Device History Records complete
□ Distribution records maintained
□ Complaint files organized
□ MDR procedures followed
□ Recall records available
□ Training records current
□ Validation documentation complete
□ Calibration records maintained
□ Audit records filed
□ Regulatory correspondence kept
□ Retention periods followed
□ Electronic records compliant
Complaint Handling
□ Complaint procedures documented
□ Complaint intake systematic
□ Investigation thorough
□ Root cause analysis performed
□ Corrective actions taken
□ MDR reportability assessed
□ Trending analysis conducted
□ Customer feedback provided
□ Records maintained properly
□ Regulatory reporting timely
□ Management review included
□ Effectiveness verified
Recall Management
□ Recall procedures established
□ Recall team identified
□ Communication plan ready
□ Product identification possible
□ Distribution records accessible
□ Mock recall conducted
□ Effectiveness checks defined
□ Regulatory notification procedures
□ Customer notification templates
□ Product retrieval procedures
□ Destruction/correction procedures
□ Termination criteria defined
Regulatory Compliance
□ FDA registration current
□ Device listing updated
□ QSR compliance demonstrated
□ UDI requirements met
□ Labeling compliant
□ Import/export compliant
□ State requirements met
□ International requirements addressed
□ Inspection readiness maintained
□ Regulatory changes tracked
□ Training on regulations current
□ Compliance metrics tracked
Audit & Improvement
□ Audit program established
□ Audit schedule maintained
□ Qualified auditors used
□ Findings tracked to closure
□ Effectiveness verified
□ Management review conducted
□ Metrics/KPIs tracked
□ Trending performed
□ Continuous improvement demonstrated
□ Best practices implemented
□ Benchmarking conducted
□ Customer satisfaction measured
How the Fda Warehouse Audit Checklist Medical Device works
Describe your audit type, scope, and timeline. Input your industry and applicable standards. The AI builds a customized fda warehouse audit checklist medical device with preparation phases, documentation requirements, and common findings prevention. Track progress, assign responsibilities, and generate audit packages. Export reports that demonstrate due diligence.
Audit failures aren’t just embarrassing – they’re expensive. Fines, remediation, and reputation damage multiply costs. This checklist prevents the preventable, turning audit preparation from last-minute panic into systematic excellence. It’s how professionals maintain continuous compliance instead of periodic scrambles.
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