翻譯后的計(jì)算機(jī)化系統(tǒng)驗(yàn)證模板

1、Authors Signature：授權(quán)者簽名授權(quán)者簽名 Your signature indicates that this document has been prepared in accordance with existing project standards and adequately reflects the tasks and deliverables necessary for validation of the equipment name您的簽名表明這份文件的準(zhǔn)備符合現(xiàn)行項(xiàng)目標(biāo)準(zhǔn)并且充分反映人物 u 和可交付使用對設(shè)備名稱驗(yàn)證的必要。Authored By：經(jīng)授權(quán)：經(jīng)

2、授權(quán)：Typed/Printed Name, Title姓名，職稱Signature簽名Date日期Unit單位Reviewers Signature：審查員簽名：審查員簽名：Your signature indicates that, you have reviewed this document and that it accurately and completely reflects the tasks and deliverables necessary for validation of the equipment name.您的簽名表明您已經(jīng)審閱了這份文件，確認(rèn)它精確并完全的反映

3、任務(wù)和可交付使用對驗(yàn)證的必要。Reviewed By:經(jīng)審閱：經(jīng)審閱：Typed/Printed Name， Title姓名，職稱Signature簽名Date日期Unit單位Typed/Printed Name， Title姓名，職稱Signature簽名Date日期Unit單位Typed/Printed Name, Title姓名,職稱Signature簽名Date日期Unit單位Quality Control/Compliance Approvers Signature：質(zhì)檢質(zhì)檢/承認(rèn)簽名承認(rèn)簽名Your signature indicates that this document co

4、mplies with reference Validation Master Plan, company standards or guidelines; and that the documentation and information contained herein complies with applicable regulatory, corporate, divisional/departmental requirements, and current Good Manufacturing Practices.您的簽名表明這份文件符合證明人驗(yàn)證總計(jì)劃，企業(yè)標(biāo)準(zhǔn)或政策，并且在此包

5、含的文件和信息符合可應(yīng)用的可調(diào)整的，共同的以及部門所有的部門的要求和現(xiàn)行的標(biāo)準(zhǔn)。Approved By：經(jīng)核準(zhǔn)：經(jīng)核準(zhǔn)：Typed/Printed Name， Title姓名，職稱Signature簽名Date日期Unit單位Typed/Printed Na me, Title姓名，職稱Signature簽名Date日期Unit單位Revision History修訂歷史紀(jì)錄修訂歷史紀(jì)錄Revision修訂本修訂本Revision Date修訂日期修訂日期Reason for Revision/Change Request修訂修訂/更改要求的原因更改要求的原因Revised By修訂人修訂人0

6、04-DEC-20022002/12/4Original Release原始版本Michael T。 Filary邁克爾116JAN20032003/1/16Updated the JETT logo on the cover page.更新封頁面的 JETT 的標(biāo)識Michael T。 Filary邁克爾Table of Contents目錄1.Introduction 緒論.51.1Purpose 目的.51.2Policy Compliance 適用的政策.51。3 Scope of Validation 驗(yàn)證范圍 .51.4Objectives 目標(biāo) .61.5Periodic Rev

7、iew 定期審查.62。 Organizational Structure 組織結(jié)構(gòu) .73.GxP Criticality AssessmentGxP 關(guān)鍵性評估.73。1 GxP Criticality Assessment RequirementsGxP 關(guān)鍵性評估要求.73.2GxP Criticality Assessment Procedures GxP 關(guān)鍵性評估-程序 83.3GxP Criticality Assessment Current StatusGxP 關(guān)鍵性評估-現(xiàn)行標(biāo)準(zhǔn).84。 Validation Strategy 驗(yàn)證策略.94。1 Life Cycle 生

8、命周期.94.2Risk Assessment 風(fēng)險(xiǎn)評估 .94.3Hardware Categories 硬件分類.94。4 Software Categories 軟件分類.94。5 Project Inputs/Outputs for Stages 項(xiàng)目各階段的輸入/輸出.104.6Acceptance Criteria for Stages 各階段的接受標(biāo) 105。 Validation Deliverables.105。1Traceability and Linkages 描述和鏈接 115。2Master List of all Validation Products and Su

9、pporting Documentation所有批準(zhǔn)產(chǎn)品和證明文件的總清單 115.3User Requirements Specification (URS） 使用說明書.115.4Functional Requirement Specification (FRS） 功能說明書.115.5Configuration Management and Change Control Documentation 配置管理和變速控制文件 115.6Vendor Qualification documentation 賣主資格認(rèn)證 115.7Design Specifications 設(shè)計(jì)說明.125.8

10、 Testing and Verification Requirements Documentation試驗(yàn)和確認(rèn)所需文件125。9 System Security系統(tǒng)安全性.135.10Operational Support運(yùn)行支持.145.11Business Continuity Plan業(yè)務(wù)持續(xù)計(jì)劃.145.12Disaster Recovery， Backup and Restoration災(zāi)難性恢復(fù)，備份及修復(fù).145。13 System Acceptance Final Report系統(tǒng)接受終報(bào)告.145.14列出任何其他需要驗(yàn)證的產(chǎn)品.156。 Acceptance Crite

11、ria可接受標(biāo)準(zhǔn).157。 Change Control變更控制.157。1 Pre-Implementation Changes預(yù)執(zhí)行變更.157。2 PostImplementation Changes執(zhí)行后變更.158。 Standard Operating Procedures SOP.158。1 SOP Responsibilities SOP 職責(zé).158.2Listing of SOPs SOP 列表.169。 Training培訓(xùn).1610。 Documentation Management資料管理.1610。1 Document Production文件產(chǎn)生.1610.2Do

12、cument Review文件回顧.1610.3Document Approval文件批準(zhǔn).1610。4 Document Issue文件發(fā)布.1610。5 Document Changes文件變更.1710.6Document Withdraw文件撤銷.1710.7Document Storage文件保存.1711。 Maintaining the Validated State驗(yàn)證狀態(tài)的維護(hù).1711。1 System Retirement系統(tǒng)引退.1712.Validation Activities Timeline驗(yàn)證執(zhí)行時間表.17Appendix A 附錄 A參與組織參與組織.18

13、Appendix B 附錄 B縮寫詞縮寫詞,定義定義.19Appendix C 附錄 C責(zé)任/時間.22Appendix D 附錄 D 可交付的驗(yàn)證.23Appendix E 附錄 E 參考 .24（Reminder of Page Intentionally Left Blank）1. Introduction緒論1.1 Purpose 目的This document, also referred to as the Plan， outlines the planned tasks and expectations for validation of the equipment name。這

14、份文件，也稱計(jì)劃，略述計(jì)劃的任務(wù)和和適當(dāng)性（現(xiàn)行GAM附錄）中關(guān)于驗(yàn)證的統(tǒng)一要求。The validation of the is limited to the unique components and control system that define the equipment. This validation effort will be conducted as a prospective validation.這份為設(shè)備名稱的驗(yàn)證計(jì)劃僅限于特殊構(gòu)成和定義設(shè)備的控制系統(tǒng).該項(xiàng)驗(yàn)證成就將會被作為一項(xiàng)預(yù)期的驗(yàn)證執(zhí)行。Provide a Brief description of equi

15、pment and principal function； Refer to User Requirement Specifications. Provide a description of the research, manufacturing， processing, packaging， holding， or distribution process for which the equipment is planned.對用戶必備使用的說明書中的設(shè)備和主要功能的闡述. 對實(shí)施計(jì)劃的設(shè)備進(jìn)行研究、生產(chǎn)、加工、包裝、存儲、分配過程的說明。1.3.1 InScope驗(yàn)證范圍The scop

16、e of validation for the equipment name includes all the following that are necessary for the system to operate. clearly define all boundaries（設(shè)備名稱)驗(yàn)證的范圍包括以下所有的系統(tǒng)運(yùn)作所必需的內(nèi)容。(明確界限）1.Controls system hardware and software控制系統(tǒng)得硬件和軟件2.Mechanical Hardware機(jī)械的硬件3.Instrumentation儀器4.Process piping輸水管道工藝5.Utilit

17、y Systems通用系統(tǒng)6.Facility設(shè)施7.其他需要的名單1.3.2 Outof-Scope驗(yàn)證范圍例外The scope of validation for the does not include：（設(shè)備名稱）驗(yàn)證的范圍不包括：1.The XYZ system is validated separately。系統(tǒng)單獨(dú)驗(yàn)證2.The Data Historian is validated separately.數(shù)據(jù)歷史單獨(dú)驗(yàn)證3.list all that are appropriate其他名單1.3.3 Related Validation相關(guān)驗(yàn)證 includes all th

18、e following that are necessary for the system to be placed into operation. 支持(設(shè)備名稱）的相關(guān)驗(yàn)證在以下情況發(fā)生:包括系統(tǒng)運(yùn)行必需的幾點(diǎn)（清晰的定義分界線）:1.Process Validation工藝驗(yàn)證2.Cleaning Studies清潔研究3.Air Classification風(fēng)力分級4.Microbiological Testing微生物試驗(yàn)5.Chemical Testing化學(xué)試驗(yàn)6.Drying Studies干燥研究7.Sterilization Studies無菌研究8.其他名單1.4 Obj

19、ectives目標(biāo)The objective of this validation plan is to outline the requirements that will demonstrate and document that all components, control system(s） and functionality associated with the equipment name are appropriate for cGMP-regulated processes。 The qualifications outlined are to be based on co

20、mpany name policies and procedures and applicable regulations, guidelines, and accepted industry practices for validation.該項(xiàng)驗(yàn)證計(jì)劃的目標(biāo)是簡述一項(xiàng)要求，該要求能夠證明所有與設(shè)備名稱相關(guān)的組成、控制系統(tǒng)和功能都是恰當(dāng)?shù)姆犀F(xiàn)行標(biāo)準(zhǔn)的工藝。資格的綜述要基于（公司名稱)政策，程序以及可應(yīng)用的規(guī)則、指導(dǎo)方針和公認(rèn)的工業(yè)驗(yàn)證實(shí)踐。1.5 Periodic Review定期回顧This Plan should be reviewed periodically to ensure c

21、ompliance and or to determine if a change is required。 Some appropriate times to review are:這份計(jì)劃應(yīng)該被定期回顧來保證符合并確定是否需要更改。一些適當(dāng)?shù)幕仡檿r間是：1. Change in Validation Master Plan驗(yàn)證主文件的更改發(fā)生時2. Change in scope occurs驗(yàn)證范圍的更改發(fā)生時3. Design change occurs設(shè)計(jì)更改發(fā)生時4. Prior to IQ and OQ在進(jìn)行和之前5. Completion of IQ and OQ和完成時See

22、 section 5 for a description of Validation Management and the process for review and revisions to this plan or refer to the applicable corporate policy review cycle.見第五部分有關(guān)驗(yàn)證管理和針對該項(xiàng)計(jì)劃見第五部分有關(guān)驗(yàn)證管理和針對該項(xiàng)計(jì)劃 的回顧、修訂過程或指適應(yīng)公司政策的回顧周期的回顧、修訂過程或指適應(yīng)公司政策的回顧周期.2。 Organizational Structure組織結(jié)構(gòu)Specific responsibilitie

23、s related to the validation of the equipment name are outlined in Appendix A。 In general, the activities associated with this project， are the responsibility of the following individuals and groups：與(設(shè)備名稱)驗(yàn)證相關(guān)的具體職責(zé)在附錄中概述.大體上，與驗(yàn)證相關(guān)的活動項(xiàng)目由以下個人和部門負(fù)責(zé):The defined role and responsibilities should include a

24、t a minimum the individuals listed below Describe each role and responsibility in a general way as they apply確定個人的任務(wù)和責(zé)任至少應(yīng)包括以下幾點(diǎn)，總體根據(jù)崗位不同描述每項(xiàng)任務(wù)和責(zé)任1.Management level Responsible for project management and planning, control of project activities/resources/costs， monitoring process， initiating correcti

25、ve action， ensuring issues/project objectives are correctly addressed/resolved， reporting to senior management， interface to QA to ensure compliance, reviewing and approving validation documentation for the project管理層：負(fù)責(zé)項(xiàng)目管理和計(jì)劃.方案，活動,資源,成本的控制，監(jiān)控工藝，2.Quality Assurance Responsible for assuring complia

26、nce with appropriate regulatory/business/technical/user community requirements， providing support for the criterion/independent review/approval of deliverables， approving completion of stage/validation status質(zhì)保:負(fù)責(zé)保證符合適當(dāng)?shù)恼{(diào)整、商業(yè)、技術(shù)、用戶群要求,支持維護(hù)標(biāo)準(zhǔn)、獨(dú)立審查、可交付的批準(zhǔn)、審批完成階段和身份驗(yàn)證等。3.System Owner Responsible for im

27、plementation/management of the system by the business user community, approving completion of stage/validation status系統(tǒng)所有者:負(fù)責(zé)執(zhí)行和管理系統(tǒng)的用戶群,審批完成階段和驗(yàn)證身份。這些任務(wù)和責(zé)任可以適當(dāng)?shù)亩x：按照他們的分工總體上定義每項(xiàng)任務(wù)和責(zé)任。1.Operations Responsible for providing操作：負(fù)責(zé)提供2.Project Level Responsible for providing項(xiàng)目水平：負(fù)責(zé)提供3.Technical and Engin

28、eering support Responsible for providing技術(shù)和工程支持：負(fù)責(zé)提供4.Validation Specialist Responsible for providing驗(yàn)證專家:負(fù)責(zé)提供5.System Administrator Responsible for providing系統(tǒng)管理:負(fù)責(zé)提供6.Purchasing Responsible for providing采供：負(fù)責(zé)提供7.List all that are appropriate其他名單3.GxP Criticality AssessmentGxP 關(guān)鍵性估計(jì)Detail the GxP c

29、riticality assessment information related to the 。 This section may reference another source of information covering this topic， such as a system inventory。詳述和（設(shè)備名稱）有關(guān)的 GxP 關(guān)鍵性估計(jì)信息。該部分包括另外一種信息，包括該主題，例如系統(tǒng)詳細(xì)目錄。 3。1GxP Criticality Assessment RequirementsGxP 關(guān)鍵性評估-要求Define the requirements used in the d

30、etermination of the levels for GxP criticality for the 。 The requirements for determination of the levels for GxP criticality may include Direct Impact， Indirect Impact， and No Impact systems。定義在決定（設(shè)備名稱）Gxp水平中使用的關(guān)鍵性要求，包括直接影響，間接影響和無影響系統(tǒng)。Direct Impact System or component within a system where the oper

31、ation， contact， data, control， alarm, or failure will have a direct impact on product quality。直接影響：系統(tǒng)或系統(tǒng)中的一個組成，對產(chǎn)品質(zhì)量有直接影響的操作,接觸，控制,預(yù)警或失敗。Indirect Impact System or component within a system where the operation， contact， data， control， alarm， or failure will not have a direct impact on product quality

32、. Indirect Impact systems typically support Direct Impact systems, thus indirect impact system may have an affect on the performance or operation of a direct impact system。間接影響：系統(tǒng)或系統(tǒng)中的一個組成，對產(chǎn)品質(zhì)量無直接影響的操作，接觸，控制，預(yù)警或失敗。間接影響系統(tǒng)專門支持直接影響系統(tǒng)，因此間接影響系統(tǒng)會對直接影響系統(tǒng)的執(zhí)行和運(yùn)作構(gòu)成影響。No Impact System or component within a sy

33、stem where the operation, contact, data， control， alarm， or failure will not have a direct or indirect impact on product quality。 No Impact systems will not support Direct Impact systems.無影響：系統(tǒng)或系統(tǒng)的一個組成，對產(chǎn)品質(zhì)量不構(gòu)成直接或間接影響的操作,接觸，控制，預(yù)警或失敗。無影響系統(tǒng)不能支持直接影響系統(tǒng)。3。2GxP Criticality Assessment ProceduresGxP 關(guān)鍵性評估-程

34、序Define the procedures used/followed in the assessment of the levels for GxP criticality for the equipment name. Develop a documented path that will be followed to determine the levels for GxP criticality for each item associated with the equipment name。 It may be helpful to develop a decision tree

35、to demonstrate the overview to the process required in determining levels for GxP criticality。 Internal procedures may be referenced, if available。定義使用的程序/(設(shè)備名稱）的 Gxp 關(guān)鍵性水平的評估的標(biāo)準(zhǔn)。開發(fā)一種具有證明的文件路徑，作為（設(shè)備名稱）GxP 關(guān)鍵性水平每一項(xiàng)目的評估標(biāo)準(zhǔn)。創(chuàng)建一個決策樹將對在 GxP 關(guān)鍵性評估中論證工藝的一般觀察要求有幫助。如果必要，可以引用國際程序作為參考.3.3GxP Criticality Assessm

36、ent Current StatusGxP 關(guān)鍵性評估-現(xiàn)行標(biāo)準(zhǔn)State the current status of the assessment for the GxP criticality levels for the equipment name。 陳述現(xiàn)行(設(shè)備名稱)的 GxP 關(guān)鍵性水平評估的要求。The Direct Impact Systems associated with the equipment name include all the following。 Clearly develop supporting rationale（設(shè)備名稱的)直接影響因素包括以下的所

37、有項(xiàng).（清楚的規(guī)定支持理論）1.Controls system hardware and software - This has been deemed a direct impact system due to控制系統(tǒng)硬件和軟件：該項(xiàng)是一個直接影響由于2.Mechanical Hardware This has been deemed a direct impact system due to機(jī)械硬件:該項(xiàng)是一個直接影響由于3.Instrumentation This has been deemed a direct impact system due to儀器:該項(xiàng)是一個直接影響由于4.P

38、rocess piping This has been deemed a direct impact system due to工藝流程:該項(xiàng)是一個直接影響由于5.Utility Systems This has been deemed a direct impact system due to效用系統(tǒng)：該項(xiàng)是一個直接影響由于6.Facility This has been deemed a direct impact system due to設(shè)備：該項(xiàng)是一個直接影響由于7.List all that are appropriate其他名單The Indirect Impact System

39、s associated with the include all the following. Clearly develop supporting rationale（設(shè)備名稱的)間接影響因素包括以下的所有項(xiàng)。（清楚的規(guī)定支持原理）1.Controls system hardware and software This has been deemed an indirect impact system due to控制系統(tǒng)硬件和軟件：該項(xiàng)是一個間接影響由于2.Mechanical Hardware - This has been deemed an indirect impact syst

40、em due to機(jī)械硬件：該項(xiàng)是一個間接影響由于3.Instrumentation This has been deemed an indirect impact system due to儀器:該項(xiàng)是一個間接影響由于4.Process piping This has been deemed an indirect impact system due to工藝流程:該項(xiàng)是一個間接影響由于5.Utility Systems - This has been deemed an indirect impact system due to效用系統(tǒng)：該項(xiàng)是一個間接影響由于6.Facility This

41、 has been deemed an indirect impact system due to設(shè)備:該項(xiàng)是一個間接影響由于7.List all that are appropriate其他名單The No Impact Systems associated with the include all the following。 Clearly develop supporting rationale（設(shè)備名稱的)無影響因素包括以下的所有項(xiàng).(清楚的規(guī)定支持原理） 1.Controls system hardware and software - This has been deemed a

42、 no impact system due to控制系統(tǒng)硬件和軟件：該項(xiàng)是一個無影響系統(tǒng)由于2.Mechanical Hardware This has been deemed a no impact system due to機(jī)械硬件：該項(xiàng)是一個無影響系統(tǒng)由于3.Instrumentation This has been deemed a no impact system due to儀器：該項(xiàng)是一個無影響系統(tǒng)由于4.Utility Systems - This has been deemed a no impact system due to工藝流程：該項(xiàng)是一個無影響系統(tǒng)由于5.Facil

43、ity - This has been deemed a no impact system due to設(shè)備：該項(xiàng)是一個無影響系統(tǒng)由于6.List all that are appropriate其他名單4.Validation Strategy驗(yàn)證策略4.1Life Cycle生命周期Define the internal requirements for development， testing, delivery, and support that define the period of time that begins when a system is conceived and e

44、nds when the system is no longer available for use。陳述國內(nèi)研發(fā)，測試,運(yùn)輸和維護(hù)的要求，定義驗(yàn)證開始的時間段（系統(tǒng)存在時開始），系統(tǒng)結(jié)束的時間（系統(tǒng)不可用時結(jié)束）。4.2Risk Assessment風(fēng)險(xiǎn)評估State the current status of the assessment for the GxP Risk and Business Risk for the 。 定義(設(shè)備名稱）的軟件種類Software components of a system can be analyzed and categorized into

45、one of the following GAMP defined categories:軟件系統(tǒng)組成可以按照以下GAMP詳述的分類方法進(jìn)行分析和歸類：Software Category 1 Operating Systems軟件分類1:運(yùn)行系統(tǒng)Software Category 2 Firmware軟件分類2：固件(軟件硬件相結(jié)合）Software Category 3 Standard Software Packages軟件分類3：標(biāo)準(zhǔn)軟件包Software Category 4 Configurable Software Packages軟件分類4：結(jié)構(gòu)軟件包Software Categ

46、ory 5 Custom Software軟件分類5:定制軟件4.5Project Inputs/Outputs for Stages項(xiàng)目各階段的輸入/輸出Define the project input and outputs for each stage of the project associated with the equipment name。 詳述（設(shè)備名稱）的相關(guān)項(xiàng)目每一階段的的輸入/輸出4。6Acceptance Criteria for Stages各階段的接受標(biāo)準(zhǔn)Define the acceptance criteria for each stage of the p

47、roject associated with the . 詳述（設(shè)備名稱)的相關(guān)項(xiàng)目各階段的接受標(biāo)準(zhǔn)。5。Validation Deliverables驗(yàn)證可交付性The balance of this Plan outlines specific validation activities and products that will be created and assembled throughout the system development life cycle and collectively will comprise the Validation Package. The P

48、lan can serve as an overview or ”road map” to the individual validation products as specified by the applicable corporate policy 。 Additional detail, including implementation information, can be found in the individual products themselves。該計(jì)劃的平衡略述產(chǎn)生和聚集于系統(tǒng)開發(fā)的整個生命過程中的具體的驗(yàn)證活動和產(chǎn)品,包含驗(yàn)證包。該計(jì)劃可以作為對公司適用政策中規(guī)定

49、的個別驗(yàn)證產(chǎn)品的一個回顧或路線圖。補(bǔ)充細(xì)節(jié)，包括執(zhí)行信息，可以在個別產(chǎn)品中找到。5。1Traceability and Linkages描述和鏈接This document links the URS, FRS， Design Specifications and the Testing Specifications （IQ, OQ， PQ) per the V-Model below: 這份文件像下面所示的 V 模型一樣與 URS, FRS, 設(shè)計(jì)闡述 和檢測說明 (IQ， OQ, PQ）鏈接使用者的需求說明 執(zhí)行條件功能闡述 運(yùn)作條件設(shè)計(jì)闡述 設(shè)立條件 構(gòu)筑體系5.2Master List

50、 of all Validation Products and Supporting Documentation所有批準(zhǔn)產(chǎn)品和證明文件的總清單5。3User Requirements Specification （URS） 使用說明書使用說明書This document describes what the equipment is intended to do and all essential requirements such as production rates， operating ranges, etc。 It is usually developed by the owner.

51、 This document links to the PQ document which tests for each of the requirements。此文件描述了儀器的用途,和對使用率，操作范圍等的主要要求，通常是儀器的持有者對其進(jìn)行改進(jìn)，此文件與對各項(xiàng)要求進(jìn)行測試的 PQ 文件相結(jié)合。5。4Functional Requirement Specification (FRS） 功能說明書功能說明書This document describes the detailed functionality of the equipment. It is usually developed b

52、y the supplier。 This document is linked to the OQ document which tests for each function。次文件對儀器詳細(xì)功能進(jìn)行的了描繪,通常是儀器供應(yīng)商對其進(jìn)行改進(jìn)，此文件與檢測各項(xiàng)功能的OQ 文件相結(jié)合.5。 5Configuration Management and Change Control Documentation配置管理和變速控制文件User RequirementsSpecification 使用要求 FunctionalSpecificationsDesign SpecificationsPerfor

53、mance QualificationOperational QualificationInstallation QualificationBuild SystemVerifies 證實(shí)Verifies 證實(shí)Verifies 證實(shí)Change control is a formal process by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect a validated and / or approved status

54、。 The intent is to determine the need for action that would ensure and document that the system maintains this status。 This process documents the preimplementation changes and post-implementation changes. Documents that require change control may include any of the Validation Products listed in sect

55、ion 5. 變化控制是正式的程序，是根據(jù)適當(dāng)?shù)闹貜?fù)檢測而得出的有代表性的檢測而提出的。其目的是決定操作規(guī)程和保持系統(tǒng)穩(wěn)定的文件.這個程序?yàn)樽兯偾昂蟮陌惭b啟用提供證明。要求執(zhí)行變速控制的文件應(yīng)該包括第 5 部分目錄中任何一個合格產(chǎn)品。5。6Vendor Qualification documentation賣主資格認(rèn)證Provide documentation that verifies that vendor(s） are qualified, competent and experienced.提供文件來證實(shí)賣主是有資格的，有能力的,有經(jīng)驗(yàn)的5.7Design Specifications

56、設(shè)計(jì)說明Include any documents required to support installation。 (The following documents are examples, but are not meant to be an exclusive list).包括所有需要支持安裝裝置的文件。（以下文件供參考,但不是完整清單）1. Detailed process descriptions, narratives, and sequence of operations詳細(xì)的工藝種類，描述和操作性的2.Subsystem definitions 子系統(tǒng)得定義3.Data F

57、low Diagrams流程表數(shù)據(jù)4.Process Flow Diagrams工藝流程數(shù)據(jù)5.System architecture dra系統(tǒng)建筑學(xué)數(shù)據(jù)6.Piping and instrumentation diagrams 管道和儀器圖表7.Control wiring diagrams控制配線圖表8.Power distribution and grounding diagrams分銷能力和基地表9.Panel layout drawings設(shè)計(jì)圖紙10. Hardware and software design specifications硬件和軟件設(shè)計(jì)說明書11. Bill of

58、 materials物料清單12. Other documents required for installation， operations and maintenance其他安裝，運(yùn)行和維護(hù)文件5。7.1Traceability Matrix矩陣描述The traceability of critical parameters and data through the design process to the final testing stage will be maintained using a matrix。 This matrix shall detail all critic

59、al equipment and software parameters and link them to their individual test cases and the document in which they appear. The requirements traceability matrix shall be maintained under change control for the life of the equipment。從設(shè)計(jì)階段到最終的測試階段的重要參數(shù)和數(shù)據(jù)的描述應(yīng)該用矩陣來表示。這個矩陣應(yīng)該詳述所有的關(guān)鍵設(shè)備和軟件的參數(shù)，并鏈接到他們各自所在的檢測文件中

60、。需求量的描述應(yīng)該維持在設(shè)備壽命變化控制以下.Authors Signature:Your signature indicates that this document has been prepared in accordance with existing project standards and adequately reflects the tasks and deliverables necessary for validation of the Authored By：Typed/Printed Name, TitleSignatureDateUnitReviewers Sign