翻譯后計(jì)算機(jī)化系統(tǒng)驗(yàn)證

1、Company LogoDOCUMENT NUMBER:PAGE:# - #1 of 43LOCATION:Revision:EFFECTIVE:Rev #yyyy.mm.ddTITLE:VALIDATION PLAN FOR THE <Equipment Name , ID# 12345 >File Name: 1968581271.docLast Save Date: 02-Jan-2020Print Date: 1/2/20<設(shè)備名稱 >驗(yàn)證的必要。Company LogoDOCUMENT NUMBER:PAGE:# - #2 of 43LOCATION:Revi

2、sion:EFFECTIVE:Rev #yyyy.mm.ddTITLE:VALIDATION PLAN FOR THE <Equipment Name , ID# 12345 >Author's Signature:授權(quán)者簽名Your signature indicates that this document has been prepared in accordance with existing project standards andadequately reflects the tasks and deliverables necessary for valid

3、ation of the <equipmentname >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(duì)<設(shè)備名稱 >驗(yàn)證的必要。Authored By:經(jīng)授權(quán)：Typed/Printed Name, TitleSignatureDateUnit姓名，職稱簽名日期單位Reviewer's Signature:審查員簽名：Your signature indicates that, you have reviewed this document and that it accurately and completely reflect

4、s the tasksand 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任務(wù)和可交付使用對(duì)Reviewed By:經(jīng)審閱：Typed/Printed Name, TitleSignatureDateUnit姓名，職稱簽名日期單位Typed/Printed Name, TitleSignatureDateUnit姓名，職稱簽名日期單位Typed/Printed Name, TitleSignatureDateUnit姓名，職稱簽名日期單位Quali

5、ty Control/Compliance Approver's Signature:質(zhì)檢 /承認(rèn)簽名Your signature indicates that this document complies with < reference Validation Master Plan, company standards or guidelines > and that the documentation and information contained herein complies with applicable regulatory, corporate, div

6、isional/departmental requirements, and current Good Manufacturing Practices.File Name: 1968581271.docLast Save Date: 02-Jan-2020Print Date: 1/2/20Company LogoDOCUMENT NUMBER:PAGE:# - #3 of 43LOCATION:Revision:EFFECTIVE:Rev #yyyy.mm.ddTITLE:VALIDATION PLAN FOR THE <Equipment Name , ID# 12345 >您

7、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)：Typed/Printed Name, TitleSignatureDateUnit姓名，職稱簽名日期單位Typed/Printed Na me, TitleSignatureDateUnit姓名，職稱簽名日期單位File Name: 1968581271.docLast Save Date: 02-Jan-2020Print Date: 1/2/20Company LogoDOCUMENT NUMBER:PAGE:#

8、 - #4 of 43LOCATION:Revision:EFFECTIVE:Rev #yyyy.mm.ddTITLE:VALIDATION PLAN FOR THE <Equipment Name , ID# 12345 >Revision History修訂歷史紀(jì)錄RevisionRevision DateReason for Revision/Change RequestRevised By修訂本修訂日期修訂 /更改要求的原因修訂人004-DEC-2002Original ReleaseMichael T. Filary2002/12/4原始版本邁克爾116-JAN-2003

9、Updated the JETT logo on the cover page.Michael T. Filary2003/1/16更新封頁(yè)面的 JETT 的標(biāo)識(shí)邁克爾Table of Contents目錄1.Introduction 緒論 .191.1Purpose目的 .191.2Policy Compliance 適用的政策 .191.3Scope of Validation 驗(yàn)證范圍 .191.4Objectives 目標(biāo) .201.5Periodic Review 定期審查 .202.Organizational Structure 組織結(jié)構(gòu) .213.GxP Criticality

10、 AssessmentGxP 關(guān)鍵性評(píng)估 .213.1GxP Criticality Assessment - RequirementsGxP 關(guān)鍵性評(píng)估要求 .223.2GxP Criticality Assessment - Procedures GxP 關(guān)鍵性評(píng)估程序223.3GxP Criticality Assessment Current StatusGxP 關(guān)鍵性評(píng)估現(xiàn)行標(biāo)準(zhǔn) .224.Validation Strategy 驗(yàn)證策略 .234.1Life Cycle 生命周期 .234.2Risk Assessment風(fēng)險(xiǎn)評(píng)估 .234.3Hardware Categories

11、 硬件分類 .244.4Software Categories 軟件分類 .244.5Project Inputs/Outputs for Stages 項(xiàng)目各階段的輸入 /輸出 .244.6Acceptance Criteria for Stages 各階段的接受標(biāo)245. Validation Deliverables .255.1 Traceability and Linkages 描述和鏈接25File Name: 1968581271.docLast Save Date: 02-Jan-2020Print Date: 1/2/20Company LogoDOCUMENT NUMBER

12、:PAGE:# - #5 of 43LOCATION:Revision:EFFECTIVE:Rev #yyyy.mm.ddTITLE:VALIDATION PLAN FOR THE <Equipment Name , ID# 12345 >5.2Master List of all Validation Products and Supporting Documentation所有批準(zhǔn)產(chǎn)品和證明文件的總清單255.3User Requirements Specification (URS) 使用說(shuō)明書 .255.4Functional Requirement Specificati

13、on (FRS) 功能說(shuō)明書 .255.5Configuration Management and Change Control Documentation26配置管理和變速控制文件5.6Vendor Qualification documentation 賣主資格認(rèn)證265.7Design Specifications 設(shè)計(jì)說(shuō)明 .265.8 Testing and Verification Requirements Documentation 試驗(yàn)和確認(rèn)所需文件275.9System Security 系統(tǒng)安全性 .285.10Operational Support 運(yùn)行支持 .295.1

14、1Business Continuity Plan 業(yè)務(wù)持續(xù)計(jì)劃 .295.12Disaster Recovery, Backup and Restoration 災(zāi)難性恢復(fù)，備份及修復(fù) .305.13System Acceptance Final Report 系統(tǒng)接受終報(bào)告 .305.14<List any additional validation products required> 列出任何其他需要驗(yàn)證的產(chǎn)品 .306.Acceptance Criteria 可接受標(biāo)準(zhǔn) .307.Change Control 變更控制 .317.1Pre-Implementation C

15、hanges 預(yù)執(zhí)行變更 .317.2Post-Implementation Changes 執(zhí)行后變更 .318.Standard Operating ProceduresSOP .318.1SOP Responsibilities SOP 職責(zé) .318.2Listing of SOPs SOP 列表 .329.Training 培訓(xùn) .3210.Documentation Management 資料管理 .3210.1Document Production 文件產(chǎn)生 .3210.2Document Review 文件回顧 .3210.3Document Approval 文件批準(zhǔn) .33

16、10.4Document Issue 文件發(fā)布 .3310.5Document Changes文件變更 .3310.6Document Withdraw 文件撤銷 .3310.7Document Storage 文件保存 .3311.Maintaining the Validated State 驗(yàn)證狀態(tài)的維護(hù) .3311.1System Retirement 系統(tǒng)引退 .3412.Validation Activities Timeline 驗(yàn)證執(zhí)行時(shí)間表 .34Appendix A 附錄 A 參與組織 .35Appendix B 附錄 B 縮寫詞，定義 .36Appendix C 附錄 C

17、 責(zé)任 /時(shí)間 .39Appendix D 附錄 D 可交付的驗(yàn)證 .41Appendix E 附錄 E 參考 .43(Reminder of Page Intentionally Left Blank)File Name: 1968581271.docLast Save Date: 02-Jan-2020Print Date: 1/2/20Company LogoDOCUMENT NUMBER:PAGE:# - #6 of 43LOCATION:Revision:EFFECTIVE:Rev #yyyy.mm.ddTITLE:VALIDATION PLAN FOR THE <Equipm

18、ent Name , ID# 12345 >1.Introduction緒論1.1Purpose目的This document, also referred to as the Plan, outlines the planned tasks and expectations for validation of the<equipment name >.這份文件，也稱計(jì)劃，略述計(jì)劃的任務(wù)和設(shè)備名稱的預(yù)期驗(yàn)證。WHO will be responsible for completion, review, and approval of these tasks.世界衛(wèi)生組織將負(fù)責(zé)

19、任務(wù)的完成、審閱和批準(zhǔn)。WHAT documentation/deliverables will be generated and/or retained as part of the Validation Package(s).什么文件 /可交付使用的將會(huì)作為驗(yàn)證包的一部分被產(chǎn)生和/或保留。HOW this documentation will be produced/created (at a macro level).這份文件將被如何制作/產(chǎn)生（在宏觀上）。1.2Policy Compliance遵守政策This Plan is being written to comply with

20、corporate policy requirements for validation as stated in the <refer to specific Validation Master Plan(s), company policies, company standards, and/or company guidelines >, and the appropriate Appendix of the current revision of GAMP.這份計(jì)劃將會(huì)遵守在涉及特殊驗(yàn)證總計(jì)劃，公司政策，公司標(biāo)準(zhǔn)和公司指導(dǎo)方針和適當(dāng)性（現(xiàn)行 GAM 附錄）中關(guān)于驗(yàn)證的統(tǒng)一要

21、求。The validation of the < equipment name> system is a cGMP requirement.設(shè)備名稱的驗(yàn)證系統(tǒng)是現(xiàn)行的一個(gè)要求。1.3Scope of Validation驗(yàn)證范圍This Validation Plan for the < equipment name> is limited to the unique components and control system that define the equipment. This validation effort will be conducted as

22、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(huì)被作為一項(xiàng)預(yù)期的驗(yàn)證執(zhí)行。Provide a Brief description of equipment and principal function; Refer to User Requirement Specifications. Provide a description of the research, manufacturing, processing, packaging, holding, or distribution process for whi

23、ch the equipment is planned.對(duì)用戶必備使用的說(shuō)明書中的設(shè)備和主要功能的闡述 . 對(duì)實(shí)施計(jì)劃的設(shè)備進(jìn)行研究、生產(chǎn)、加工、包裝、存儲(chǔ)、分配過(guò)程的說(shuō)明。1.3.1In-Scope驗(yàn)證范圍File Name: 1968581271.docLast Save Date: 02-Jan-2020Print Date: 1/2/20Company LogoDOCUMENT NUMBER:PAGE:# - #7 of 43LOCATION:Revision:EFFECTIVE:Rev #yyyy.mm.ddTITLE:VALIDATION PLAN FOR THE <Equi

24、pment Name , ID# 12345 >The scope 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

25、機(jī)械的硬件3. Instrumentation儀器4. Process piping輸水管道工藝5. Utility Systems通用系統(tǒng)6. Facility設(shè)施7. <list all that are appropriate>其他需要的名單1.3.2Out-of-Scope驗(yàn)證范圍例外The scope of validation for the <equipment name> 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

26、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1.3.3Related Validation相關(guān)驗(yàn)證<Insert a description of any existing or planned validation that is relevant to the validation of this system. The use of prior data may be considered either as reference for test meth

27、ods or directly replacing tests, if the systems configuration can be shown to be the same now as at the time the data was collected>File Name: 1968581271.docLast Save Date: 02-Jan-2020Print Date: 1/2/20Company LogoDOCUMENT NUMBER:PAGE:# - #8 of 43LOCATION:Revision:EFFECTIVE:Rev #yyyy.mm.ddTITLE:V

28、ALIDATION PLAN FOR THE <Equipment Name , ID# 12345 >插入現(xiàn)有的或計(jì)劃的與本驗(yàn)證系統(tǒng)有關(guān)的驗(yàn)證的描述。如果系統(tǒng)配置和數(shù)據(jù)采集時(shí)是一致的，前期數(shù)據(jù)的使用可以作為試驗(yàn)方法的參考或直接替代試驗(yàn)，The related validation that will occur in support of the < necessary for the system to be placed into operation. <equipment name> includes all the following that are

29、clearly define all boundaries>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(jí)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(wú)菌研究8. <list all that are appropriate>其他名單1.4O

30、bjectives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

31、based on < company 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(jiǎn)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。1.5Periodic Review定期回顧File Name: 1968581271.docLast Save

32、 Date: 02-Jan-2020Print Date: 1/2/20Company LogoDOCUMENT NUMBER:PAGE:# - #9 of 43LOCATION:Revision:EFFECTIVE:Rev #yyyy.mm.ddTITLE:VALIDATION PLAN FOR THE <Equipment Name , ID# 12345 >This Plan should be reviewed periodically to ensure compliance and or to determine if a change is required.Some

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

34、he 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(duì)該項(xiàng)計(jì)劃的回顧、修訂過(guò)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 responsibilities related to the validation of the<>are outlined in Appendix A. Inequipment namegeneral, the

35、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(dòng)項(xiàng)目由以下個(gè)人和部門負(fù)責(zé)：<The defined role and responsibilities should include at a minimum the individuals listed below - Describe each role and responsibility in a gene

36、ral way as they apply >確定個(gè)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 corrective action, ensuring issues/projectobjectives are correctly addressed/resolved, rep

37、orting to senior management, interface to QA to ensurecompliance, 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(dòng)，資源，成本的控制，監(jiān)控工藝，2.Quality Assurance Responsible for assuring compliance with appropriateregulatory/business/technical/user community requirements, provi

38、ding support for the criterion/independentreview/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 implementation/management of the system by the business usercommunity, approving comple

39、tion 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。<These role and responsibilities may be defined as appropriate - Describe each role and responsibility in a general way as they apply>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。File Name: 1968581271.docLast Save Date: 02-Jan-2020Print Date

40、: 1/2/20Company LogoDOCUMENT NUMBER:PAGE:# - #10 of 43LOCATION:Revision:EFFECTIVE:Rev #yyyy.mm.ddTITLE:VALIDATION PLAN FOR THE <Equipment Name , ID# 12345 >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 Engineering 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 Cri