Installation qualification(IQ)（按照是实际系统配置调整 Tailor it to actual configuration）

IQ-1

文件确认 Document verification

IQ-2

仪器/仪表校准确认Instruments/Meters calibration verification

IQ-3

硬件安装环境确认Hardware installation environment verification

IQ-4

软件安装环境确认Software installation environment verification

IQ-5

仪器及其部件确认Instruments and components installation verification

IQ-6

公用系统连接确认 Utility connection verification

IQ-7

软件/固件版本确认 Software/firmware version verification

IQ-8

系统配置确认 System configuration verification

Operational qualification(OQ)（按照是实际系统配置调整 Tailor it to actual configuration）

OQ-1

启动和关闭确认 System Startup and shutdown verification

OQ-2

安全访问确认Secure access verification

OQ-3

用户管理功能确认 User management function verification

OQ-4

用户权限确认 User privileges verification

OQ-5

分析方法管理功能确认Analysis method management function verification

OQ-6

数据处理功能确认Data processing function verification

OQ-7

报告/打印功能确认 Report/Print function verification

OQ-8

数据导出功能确认 Data export function verification

OQ-9

数据备份和恢复确认 Data backup & restore verification

OQ-10

数据存储安全确认Data store security verification

OQ-11

报警功能确认Alarm function verification

OQ-12

电子记录时间溯源确认 electronical record time source verification

OQ-13

通信中断恢复确认 Community interruption recovery verification

OQ-14

断电恢复确认 Power interruption recovery verification

OQ-15

电子签名功能确认(如适用) Electronic signature function verification (if applicable)

OQ-16

审计追踪功能确认(如适用) Audit trail function verification (if applicable)

Performance qualification(PQ)（按照是实际系统配置调整 Tailor it to actual configuration）

PQ-1

泄漏测试

Leak test

PQ-2

压力/流量的准确性和稳定性

Pressure/flow accuracy and stability

PQ-3

进样重复性Repeatability of GC injections

-峰面积精度Peak areas

-保留时间的重复性确认Retention times

PQ-4

进样器、柱温箱的准确性和稳定性：保留时间的重复性确认

Injector/ oven temperature accuracy and stability

PQ-6

顶空进样Headspace injector 

重复性确认-保留时间和峰面积Repeatability of Headspace injections-Retention times & Peak areas

PQ-7

顶空进样Headspace injector

小瓶加热器温度确认Vial heater temperature

PQ-8

检测器线性和进样器残留确认

Linearity & Carry over verification

PQ-9

FID检测器噪音确认

FID detector: noise verification

PQ-9

FID检测器漂移确认

FID detector: drift verification