OQ温度验证系统验证方案中英对照

毒手药王邓智先

OQ温度验证系统验证

方案中英对照

3.        OPERATIONAL QUALIFICATION运行确认
Overall Objective概述

This Operational Qualification (OQ) describes and documents a set of tests to be performed on the hardware and software that comprise the Thermal Validation System XpertVal.  This set of OQ tests will determine if the Thermal Validation System XpertVal functions as specified in the Functional Requirement Specification (FRS), the Design Specification (DS) as well as Thermal Validation System XpertVal documentation. Copies of the document are at the location specified in Section 2.  The OQ will be performed as part of the validation for the Thermal Validation System XpertVal.  Any changes to the Thermal Validation System XpertVal system configuration, other than those comprised in this document, may require revalidation as defined in the Change Control Procedures. 本运行确认（OQ）描述和说明了用于在XpertVal温度验证系统硬件和软件上执行的一整套测试。如果XpertVal温度验证系统的功能如功能需求说明（FRS）、设计说明（DS）和XpertVal温度验证系统的文件所述，本套OQ测试将会被确定。文件的副本在第一部分被说明 。OQ将会被当作XpertVal温度验证系统的验证而执行。XpertVal温度验证系统配置的任何更改、文件中其他条款的更改需要在更改控制程序中重新做出法定的说明。

Purpose目的

To verify the Thermal Validation System XpertVal performs its intended functions properly, consistently and according to the defined requirements. 为了验证XpertVal温度验证系统可以根据规定的需求自始至终地正确地执行其功能，

Scope范围

This document serves as a guide to members of the OQ Team in their on-site review of the Thermal Validation System XpertVal, personal computer and components. This instrument with the control program is a self-contained computer system which provides monitoring and data processing. 现场检查XpertVal温度验证系统时，本文件可以作为一个指导服务于OQ团队的成员，本设备的控制系统是一个自带的计算机系统，可以提供监控和数据处理。。


4.        RATIONALE 依据

Data logger unit and integration testing was performed by Fluke and is beyond the scope of this document. Compliance with System Lifecycle principles for Unit and Integration testing can be ascertained through vendor audit. The validation manual for Hydra or Agilent data logger can be provided separately by Lives International.  
数据记录单元和集成测试由Lives国际执行，其不在本文件范围之内。数据单元和集成测试的周期系统原理的规定，可以在卖方的审计中查到。数据记录仪的验证手册由Lives国际提供。
Test Environment测试环境

The system under test consists of a data logger, a temperature standard and a temperature block  attached to a computer via RS-232 cables.  The software used is XpertVal software.  The system is being tested in its normal operating environment.
系统由以下配置测试，一个数据记录器，一个温度标准，一个附在通过RS-232电缆连接在电脑上的温度干阱。使用XpertVal软件。系统在通常操作环境下测试。

sulihua

谢谢分享。

豌豆机枪

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小洁

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psi2010

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glm1024

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