Qualification Execution Checklist

Equipment: Water System (PW/WFI) – Point of Use for LVP

Subcategory: IV Infusions (LVP/SVP – Bags/Bottles)

Area: Utilities

DQ/IQ/OQ/PQ: 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 status verified

Protocol Readiness and Approvals

Protocol approved
Protocol distributed to all stakeholders

Execution Controls

Good Documentation Practices (GDP) followed
Data recording procedures in place
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA review completed

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