toc驗(yàn)證方案和報(bào)告

1、最新 精品 Word 歡迎下載 可修改EXECUTION APPROVAL SIGNATURES批準(zhǔn)執(zhí)行簽名 批準(zhǔn)執(zhí)行簽名The signatures below indicate approval of this protocol and its attachments and indicate that it is ready for execution. Any changes or modifications to t

2、he intent or the acceptance criteria of this protocol, following approval, requires the generation of an amendment which must be approved prior to execution. 下面的簽名表示批準(zhǔn)本文件及其附件，且表明已經(jīng)為執(zhí)行作好了準(zhǔn)備。在批準(zhǔn)后，對(duì)本文件的目的或驗(yàn)收標(biāo)準(zhǔn)進(jìn)行的 任何改變或修正都

3、必須起改善的作用，在執(zhí)行以前就必須取得批準(zhǔn)。***Company LTD: Date***: Date***: Date1.0 SCOPE: 范圍 范圍 ...............................................................................................................................................

4、.......................42.0 PURPOSE: 范圍 范圍.................................................................................................................................................................4最新 精品 Word 歡迎下

5、載 可修改1.0 SCOPE:范圍 范圍This Installation/Operational Qualification (IOQ) study will be performed on the Total Organic Carbon Analyzer (TOC) located in ***. 本安裝/操作確認(rèn)（IOQ）文件應(yīng)用于位于***的總有機(jī)碳分析器(TOC)。This protocol describes the

6、equipment, test procedures, specifications, documents, and references used to establish that the TOC has been installed and operates in accordance with the manufacturer’s design specifications, and those of *** Company

7、, LTD. The facility will be referred to as *** through out the remainder of this document. The unit will be referred to as the “TOC” throughout this document. 本文件內(nèi)容涉及設(shè)備、測(cè)試步驟、規(guī)格、文檔和參考書目，這些是用來(lái)確保 TOC 已經(jīng)按生產(chǎn)商設(shè)計(jì)規(guī)范和 ***公司要求安裝

8、和操作。本文件下文中工廠指的是***，單元指的是“TOC”。All firmware that is qualified, as part of this protocol, shall be identified as to version or other unique characteristic during Installation Qualification and a Firmware Letter of Assuran

9、ce included in the documentation. Hardware or firmware associated with the instrument or system shall be under configuration control with change control procedures in place. 作為本文件的一部分，在安裝確認(rèn)和文件中的固件質(zhì)保書中，固件的版本和其他唯一的標(biāo)識(shí)號(hào)都必

10、須識(shí)別。 與儀器或系統(tǒng)有關(guān)的硬件或固件都有結(jié)構(gòu)控制，且有在線變化控制。Functional testing of the integrated system will be performed to ensure system integrity where necessary. 如果需要，可對(duì)整個(gè)系統(tǒng)進(jìn)行功能性測(cè)試，確認(rèn)系統(tǒng)的完整性。2.0 PURPOSE:目的 目的The execution of this protocol wil

11、l demonstrate and document that the TOC has been installed and operates according to the manufacturer's specifications and *** requirements. 本文件的執(zhí)行將記錄和證明 TOC 已經(jīng)按生產(chǎn)商規(guī)范和***要求安裝和操作。3.0 BACKGROUND:背景 背景The TOC is a new

12、piece of equipment purchased specifically for use at ***. TOC 是為***使用而特別采購(gòu)的一套新設(shè)備。4.0 INTRODUCTION:介紹 介紹Installation checks will be performed to verify and document that the equipment is installed with the proper suppor

13、ting utilities, services, and components. All instrument calibration, standardization, or adjustment will be performed and documented for the measuring equipment used during the execution of this protocol. Standards u