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

PQ-1

标准操作规程确认Verification of SOP

PQ-2

样品检测流程确认Verification of Sample Test Process

PQ-3

吸光度灵敏度和精密度确认Verification Absorption Sensitivity and Precision

PQ-4

吸光度线性确认Verification Absorption Linearity

PQ-5

波长准确度确认Verification Wavelength Accuracy

PQ-6

光度噪声确认Verification Photometric Noise