Automated Visual Inspection (AVI) System – Qualification Execution Checklist

Qualification Execution Checklist for Automated Visual Inspection (AVI) System

Subcategory: NDDS – NDDS Packaging & Integrity

Area: Production

DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes

CSV Required: Yes

Pre-start Checks

Training completed
SOPs reviewed and approved
User Requirements Specification (URS) approved
Regulatory Approval (RA) obtained

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) status verified

Protocol Readiness and Approvals

Protocol prepared
Protocol approved by relevant stakeholders

Execution Controls

Good Documentation Practices (GDP) followed
Data recording completed
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
Quality Assurance (QA) review completed