Commissioning
Engineering acceptance of equipment and system function.
Validate
Validation
Commissioning, qualification, and validation nest. Zhenchang writes the qualification so the builder is not the only author.
Plan the qualificationQualification
GxP acceptance of the facility and the laboratory.
Validation
Hardware, software, and process parameters together.
HVAC — Leak test, PAO, air balance, recovery.
- CleanroomAir changes, ΔP, particles, light, airflow
- HVACLeak, PAO, balance, recovery
- Process gasGas qualification
- WaterPW / WFI qualification
- SterilizerAutoclave qualification
- Cold chainCold room, warehouse, mapping
- ComputerizedPLC / CSV
確效 is Validation. 驗證 is Qualification. 測試 is Commissioning. A local team works to international GxP standards.
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