Qualification Execution Checklist for CO2 Incubator

Area: Production/Cell Culture

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

CSV Required: Yes

Pre-start

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

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) completed

Protocol Readiness and Approvals

Qualification Protocols prepared
Protocols approved by Engineering
Protocols approved by Validation
Protocols approved by QA

Execution Controls

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

Review and Approvals

Review by Engineering completed
Review by Validation completed
Review by QA completed