Implant Cutting Machine – Qualification Execution Checklist

Qualification Execution Checklist

Equipment: Implant Cutting Machine

Subcategory: Implants (Drug-Eluting / Biodegradable)

Area: Production

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

CSV Required: Yes

Pre-start

Training completed
SOPs reviewed and approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
PM completed

Protocol Readiness and Approvals

Protocol ready for execution
Approvals obtained

Execution Controls

GDP followed
Data recorded accurately
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA approval obtained

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