Qualification Execution Checklist

Equipment: Isolator / RABS System

Subcategory: Prefilled Syringes & Cartridges

Area: Production

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

CSV Required: Yes

Pre-start Checks

Training completed
SOPs approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
PM schedule adhered to

Protocol Readiness and Approvals

Protocol finalized
Protocol approved by Engineering
Protocol approved by Validation
Protocol approved by QA

Execution Controls

GDP maintained
Data recording complete
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA review completed