IQ温度验证系统验证方案中英对照

毒手药王邓智先

IQ温度验证系统验证方案中英对照


2.        Scope of  Testing 测试范围
This Installation Qualification (IQ) test protocol for the XpertVal Thermal Validation System describes and documents the following:  温度验证系统的安装资格描述和文件如下
1.        demonstrate the successful hardware and software installation of the XpertVal System, personal computer system, and printer, 演示安装在XpertLog系统中的硬件和软件、个人电脑系统安装，及打印机
2.        the hardware and software are installed according to vendor guidelines, 供应商提供的软件和硬件安装
3.        establish confidence that the XpertVal System will conform to the application requirements for which it was designed.   确认XpertLog系统的应用应符合他的设计要求。
-        The XpertVal, personal computer system, and printer will be installed in accordance with engineering and vendor specifications验证系统，个人电脑系统，打印机的安装将符合技术工艺和供应商的说明书
-        The XpertVal will be installed safely. XpertLog验证系统安装的安全性
-        The equipment installation will satisfy acceptance criteria, and dynamic numeric requirements specified within this Protocol and the requirements specification设备安装达到的验收标准，并在本议定书的要求和指定的动态数字的要求规范
-        The XpertVal System will operate safely XpertLog系统的操作的安全性
-        Engineering & Maintenance documentation will be obtained and appropriately retained保留技术工艺和维护保养文件
Once system installation is completed, execution of the Operational Qualification (OQ) can proceed before implementation of the system for usage. 一旦系统安装完成后，使用之前实行的运行确认（OQ）

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