1、【精品文檔】如有侵權(quán)，請(qǐng)聯(lián)系網(wǎng)站刪除，僅供學(xué)習(xí)與交流.精品文檔.翻譯后的計(jì)算機(jī)化系統(tǒng)驗(yàn)證模板【精品文檔】如有侵權(quán)，請(qǐng)聯(lián)系網(wǎng)站刪除，僅供學(xué)習(xí)與交流.精品文檔.【精品文檔】如有侵權(quán)，請(qǐng)聯(lián)系網(wǎng)站刪除，僅供學(xué)習(xí)與交流.精品文檔.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 ne

2、cessary for validation of the 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)驗(yàn)證的必要。Authored By:經(jīng)授權(quán)：經(jīng)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

3、and deliverables necessary for validation of the .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)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 A

4、pprovers Signature:質(zhì)檢質(zhì)檢/承認(rèn)簽名承認(rèn)簽名Your signature indicates that this document complies with ; 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，

5、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(mén)所有的部門(mén)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【精品文檔】如有侵權(quán)，請(qǐng)聯(lián)系網(wǎng)站刪除，僅供學(xué)習(xí)與交流.精品文檔.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/Chang

6、e 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004-DEC-20022002/12/4Original Release原始版本Michael T. Filary邁克爾116-JAN-20032003/1/16Updated the JETT logo on the cover page.更新封頁(yè)面的 JETT 的標(biāo)識(shí)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.51.3Scope of Valida

7、tion 驗(yàn)證范圍 .51.4Objectives 目標(biāo) .61.5Periodic Review 定期審查.62.Organizational Structure 組織結(jié)構(gòu) .73.GxP Criticality AssessmentGxP 關(guān)鍵性評(píng)估.73.1GxP Criticality Assessment - RequirementsGxP 關(guān)鍵性評(píng)估要求.73.2GxP Criticality Assessment - Procedures GxP 關(guān)鍵性評(píng)估程序 83.3GxP Criticality Assessment Current StatusGxP 關(guān)鍵性評(píng)估現(xiàn)行標(biāo)準(zhǔn).

8、84.Validation Strategy 驗(yàn)證策略.94.1Life Cycle 生命周期.94.2Risk Assessment 風(fēng)險(xiǎn)評(píng)估 .94.3Hardware Categories 硬件分類.94.4Software Categories 軟件分類.94.5Project 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.105.1 Traceability and Linkages 描述和鏈接 115.2Mas

9、ter 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 115.3User Requirements Specification (URS) 使用說(shuō)明書(shū).115.4Functional Requirement Specification (FRS) 功能說(shuō)明書(shū).115.5Configuration Management and Change Control Documentation 配置管理和變速控制文件 115.6Vendor Qualification documentation 賣(mài)主

10、資格認(rèn)證 115.7Design Specifications 設(shè)計(jì)說(shuō)明.125.8 Testing and Verification Requirements Documentation試驗(yàn)和確認(rèn)所需文件125.9System 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).145.13System Acceptance Final Report系統(tǒng)接受終報(bào)告.1

11、45.14列出任何其他需要驗(yàn)證的產(chǎn)品.156.Acceptance Criteria可接受標(biāo)準(zhǔn).15【精品文檔】如有侵權(quán)，請(qǐng)聯(lián)系網(wǎng)站刪除，僅供學(xué)習(xí)與交流.精品文檔.7.Change Control變更控制.157.1Pre-Implementation Changes預(yù)執(zhí)行變更.157.2Post-Implementation Changes執(zhí)行后變更.158.Standard Operating Procedures SOP.158.1SOP Responsibilities SOP 職責(zé).158.2Listing of SOPs SOP 列表.169.Training培訓(xùn).1610.Doc

12、umentation Management資料管理.1610.1Document Production文件產(chǎn)生.1610.2Document Review文件回顧.1610.3Document Approval文件批準(zhǔn).1610.4Document Issue文件發(fā)布.1610.5Document Changes文件變更.1710.6Document Withdraw文件撤銷(xiāo).1710.7Document Storage文件保存.1711.Maintaining the Validated State驗(yàn)證狀態(tài)的維護(hù).1711.1System Retirement系統(tǒng)引退.1712.Valida

13、tion Activities Timeline驗(yàn)證執(zhí)行時(shí)間表.17Appendix A 附錄 A參與組織參與組織.18Appendix B 附錄 B縮寫(xiě)詞，定義縮寫(xiě)詞，定義.19Appendix C 附錄 C責(zé)任/時(shí)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)【精品文檔】如有侵權(quán)，請(qǐng)聯(lián)系網(wǎng)站刪除，僅供學(xué)習(xí)與交流.精品文檔.1. Introduction緒論1.1 Purpose 目的This document, also referred to as

14、 the Plan, outlines the planned tasks and expectations for validation of the .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)任務(wù)的完成、審閱和批準(zhǔn)。世界衛(wèi)生組織將負(fù)責(zé)任務(wù)的完成、審閱和批準(zhǔn)。WHAT documentation/deliverables will be generated and/or retained as part of

15、 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這份文件將被如何制作/產(chǎn)生（在宏觀上）。產(chǎn)生（在宏觀上）。1.2 Policy Compliance遵守政策This Plan is being written to comply with corporate policy requirements for validation as stated in the , and t

16、he 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)一要求。The validation of the 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。1.3 Scope of Validation驗(yàn)證范圍This Validation Plan for the is limited to the unique components and control system tha

17、t 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(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, manufactur

18、ing, processing, packaging, holding, or distribution process for which the equipment is planned.對(duì)用戶必備使用的說(shuō)明書(shū)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。1.3.1 In-Scope驗(yàn)證范圍The scope of validation for the includes all the following that are necessary for the system to operate. （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

19、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【精品文檔】如有侵權(quán)，請(qǐng)聯(lián)系網(wǎng)站刪除，僅供學(xué)習(xí)與交流.精品文檔.2.Mechanical Hardware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.其他需要的名單1.3.2 Out-of-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

20、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.其他名單1.3.3 Related Validation相關(guān)驗(yàn)證插入現(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 includes all the following that are necessary for th

21、e 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【精品文檔】如有侵權(quán)，請(qǐng)聯(lián)系網(wǎng)站刪除，僅供學(xué)習(xí)與交流.精品文檔.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.其他名單1.4 Objectiv

22、es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 are appropriate for cGMP-regulated processes. The qualifications outlined are to be based on policies and procedure

23、s 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。1.5 Periodic Review定期回顧This Plan should be reviewed periodically to ensure compliance and or to determine if

24、a change is required. Some 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 V

25、alidation Management and the process for review and revisions to this plan or refer to the applicable corporate policy review cycle.見(jiàn)第五部分有關(guān)驗(yàn)證管理和針對(duì)該項(xiàng)計(jì)劃見(jiàn)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。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)【精品文檔】如有侵權(quán)，請(qǐng)聯(lián)系網(wǎng)站刪除，僅供學(xué)習(xí)與交流.精品文檔.Specific responsibilitie

26、s related to the validation of the 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(dòng)項(xiàng)目由以下個(gè)人和部門(mén)負(fù)責(zé)：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 f

27、or project management and planning, control of project activities/resources/costs, monitoring process, initiating corrective action, ensuring issues/project objectives are correctly addressed/resolved, reporting to senior management, interface to QA to ensure compliance, reviewing and approving vali

28、dation 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 appropriate regulatory/business/technical/user community requirements, providing support for the criterion/independent review/approval of deliverables, approving complet

29、ion 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 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)

30、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 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.Purchasin

31、g - Responsible for providing采供：負(fù)責(zé)提供7.其他名單3.GxP Criticality AssessmentGxP 關(guān)鍵性估計(jì)【精品文檔】如有侵權(quán)，請(qǐng)聯(lián)系網(wǎng)站刪除，僅供學(xué)習(xí)與交流.精品文檔.Detail the GxP criticality 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

32、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(píng)估要求Define the requirements used in the determination 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

33、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(wú)影響系統(tǒng)。Direct Impact System or component within a system where the operation, 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(gè)組成，對(duì)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 w

34、ithin a system where the operation, contact, data, control, alarm, or failure will not have a direct impact on product quality. 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

35、影響：系統(tǒng)或系統(tǒng)中的一個(gè)組成，對(duì)產(chǎn)品質(zhì)量無(wú)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(mén)支持直接影響系統(tǒng)，因此間接影響系統(tǒng)會(huì)對(duì)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 system 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 Im

36、pact systems.無(wú)影響：系統(tǒng)或系統(tǒng)的一個(gè)組成，對(duì)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(wú)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(píng)估-程序Define the procedures used/followed in the assessment of the levels for GxP criticality for the . Develop a documented path that will be followed to determine the levels for

37、 GxP criticality for each item associated with the . It may be helpful to develop a decision tree 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(píng)估的標(biāo)準(zhǔn)。開(kāi)發(fā)一種具有證明的文件路徑，作為（設(shè)備名稱）G

38、xP 關(guān)鍵性水平每一項(xiàng)目的評(píng)估標(biāo)準(zhǔn)。創(chuàng)建一個(gè)決策樹(shù)將對(duì)在 GxP 關(guān)鍵性評(píng)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(guó)際程序作為參考。3.3GxP Criticality Assessment Current StatusGxP 關(guān)鍵性評(píng)估-現(xiàn)行標(biāo)準(zhǔn)State the current status of the assessment for the GxP criticality levels for the . 陳述現(xiàn)行（設(shè)備名稱）的 GxP 關(guān)鍵性水平評(píng)估的要求。The Direct Impact Systems associated with the include all t

39、he following. （設(shè)備名稱的）直接影響因素包括以下的所有項(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(gè)直接影響由于【精品文檔】如有侵權(quán)，請(qǐng)聯(lián)系網(wǎng)站刪除，僅供學(xué)習(xí)與交流.精品文檔.2.Mechanical Hardware - This has been deemed a direct impact system due to機(jī)械硬件：該項(xiàng)是一個(gè)直接影響由于3.Instrumentation

40、This has been deemed a direct impact system due to儀器：該項(xiàng)是一個(gè)直接影響由于4.Process piping - This has been deemed a direct impact system due to工藝流程：該項(xiàng)是一個(gè)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(gè)直接影響由于6.Facility - This has been deemed a direct impact system due to設(shè)備

41、：該項(xiàng)是一個(gè)直接影響由于7.其他名單The Indirect Impact Systems associated with the include all the following. （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(gè)間接影響由于2.Mechanical Hardware - This has been deemed an indirect i

42、mpact system due to機(jī)械硬件：該項(xiàng)是一個(gè)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(gè)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(gè)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(gè)間接影響由于6.F

43、acility - This has been deemed an indirect impact system due to設(shè)備：該項(xiàng)是一個(gè)間接影響由于7.其他名單The No Impact Systems associated with the include all the following. （設(shè)備名稱的）無(wú)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 no impact system due to控制系統(tǒng)硬件和軟件：該項(xiàng)是一個(gè)無(wú)影響系統(tǒng)由于2.Mec

44、hanical Hardware - This has been deemed a no impact system due to機(jī)械硬件：該項(xiàng)是一個(gè)無(wú)影響系統(tǒng)由于【精品文檔】如有侵權(quán)，請(qǐng)聯(lián)系網(wǎng)站刪除，僅供學(xué)習(xí)與交流.精品文檔.3.Instrumentation This has been deemed a no impact system due to儀器：該項(xiàng)是一個(gè)無(wú)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(gè)無(wú)影響系統(tǒng)由于5.Facility - This has be

45、en deemed a no impact system due to設(shè)備：該項(xiàng)是一個(gè)無(wú)影響系統(tǒng)由于6.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 ends when the system is no longer available for

46、 use.陳述國(guó)內(nèi)研發(fā)，測(cè)試，運(yùn)輸和維護(hù)的要求，定義驗(yàn)證開(kāi)始的時(shí)間段（系統(tǒng)存在時(shí)開(kāi)始），系統(tǒng)結(jié)束的時(shí)間（系統(tǒng)不可用時(shí)結(jié)束）。4.2Risk Assessment風(fēng)險(xiǎn)評(píng)估State the current status of the assessment for the GxP Risk and Business Risk for the . The process needs to address the following questions:陳述現(xiàn)行（設(shè)備名稱）的 GxP 關(guān)鍵性水平評(píng)估的風(fēng)險(xiǎn)和商業(yè)風(fēng)險(xiǎn)。該程序必須包括以下問(wèn)題：Does this automated system requ

47、ire validation?自動(dòng)化系統(tǒng)需要驗(yàn)證嗎？How much validation is required for this system?該系統(tǒng)要求多少驗(yàn)證？What aspects of the system or process are critical to product and patient safety?系統(tǒng)的哪個(gè)方面或工藝對(duì)產(chǎn)品和患者安全性是關(guān)鍵性因素？What aspects of the system or process are critical to business?系統(tǒng)的哪個(gè)方面或工藝過(guò)程對(duì)商業(yè)是關(guān)鍵性因素?4.3Hardware Categories硬件

48、分類Define the categories of the hardware associated with the . 定義(設(shè)備名稱)的硬件種類Hardware components of a system can be analyzed and categorized into one of the following GAMP defined categories:硬件系統(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：Hardware Category 1 Standard Hardware Components硬件分類1: 標(biāo)準(zhǔn)硬件組成 Hardware Category

49、2 Custom Built Hardware Components【精品文檔】如有侵權(quán)，請(qǐng)聯(lián)系網(wǎng)站刪除，僅供學(xué)習(xí)與交流.精品文檔.硬件分類2：定制的硬件組成4.4Software Categories軟件分類Define the categories of the software associated with the . 定義(設(shè)備名稱)的軟件種類Software components of a system can be analyzed and categorized into one of the following GAMP defined categories:軟件系統(tǒng)組成可以

50、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 Category 5 Custom Software軟件分類5：定制軟件4.5Project Inputs/Outp

51、uts 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 . 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 project 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 Del

52、iverables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 Plan can serve as an overview or road map to the individual validati

53、on products as specified by the . 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(kāi)發(fā)的整個(gè)生命過(guò)程中的具體的驗(yàn)證活動(dòng)和產(chǎn)品，包含驗(yàn)證包。該計(jì)劃可以作為對(duì)公司適用政策中規(guī)定的個(gè)別驗(yàn)證產(chǎn)品的一個(gè)回顧或路線圖。補(bǔ)充細(xì)節(jié)，包括執(zhí)行信息，可以在個(gè)別產(chǎn)品中找到。5.1Traceability and Linkages描述和鏈接【精品文檔】如有侵權(quán)，請(qǐng)聯(lián)系網(wǎng)站刪除，僅供學(xué)習(xí)與

54、交流.精品文檔.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(cè)說(shuō)明 (IQ, OQ, PQ)鏈接使用者的需求說(shuō)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 of all Validation Products and Supporting Documentation所有批準(zhǔn)產(chǎn)品和證明

55、文件的總清單5.3User Requirements Specification (URS) 使用說(shuō)明書(shū)使用說(shuō)明書(shū)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. This document links to the PQ document which tests for each of t

56、he requirements.此文件描述了儀器的用途，和對(duì)使用率，操作范圍等的主要要求，通常是儀器的持有者對(duì)其進(jìn)行改進(jìn)，此文件與對(duì)各項(xiàng)要求進(jìn)行測(cè)試的 PQ 文件相結(jié)合。5.4Functional Requirement Specification (FRS) 功能說(shuō)明書(shū)功能說(shuō)明書(shū)This document describes the detailed functionality of the equipment. It is usually developed by the supplier. This document is linked to the OQ document which

57、tests for each function.次文件對(duì)儀器詳細(xì)功能進(jìn)行的了描繪，通常是儀器供應(yīng)商對(duì)其進(jìn)行改進(jìn)，此文件與檢測(cè)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Change control is a formal process by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect a v

58、alidated and / or approved status. The intent is to determine the need for action that would ensure and document that the system maintains this status. This process documents the pre-implementation changes and post-implementation changes. Documents that require change control may include any of the

59、Validation Products listed in section 5. 變化控制是正式的程序，是根據(jù)適當(dāng)?shù)闹貜?fù)檢測(cè)而得出的有代表性的檢測(cè)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(gè)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(gè)合格產(chǎn)品。5.6Vendor Qualification documentation賣(mài)主資格認(rèn)證Provide documentation that verifies that vendor(s) are qualified, competent and experienced.提供文件來(lái)證實(shí)賣(mài)主是有資格的

60、，有能力的，有經(jīng)驗(yàn)的5.7Design Specifications設(shè)計(jì)說(shuō)明User RequirementsSpecification 使用要求 FunctionalSpecificationsDesign SpecificationsPerformance QualificationOperational QualificationInstallation QualificationBuild SystemVerifies 證實(shí)Verifies 證實(shí)Verifies 證實(shí)【精品文檔】如有侵權(quán)，請(qǐng)聯(lián)系網(wǎng)站刪除，僅供學(xué)習(xí)與交流.精品文檔.Include any documents requir