翻譯后的計算機化系統(tǒng)驗證模板

1、精品感謝下載載精品Author's Signature:授權者簽名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備符合現(xiàn)行項目標準并且充分反映人物u 和可交付使用對< 設備名稱 &

2、gt; 驗證的必要。Authored By:經(jīng)授權：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 completelyreflects the tasks and deliverables necessary for validation of the <equipment name>

3、.您的簽名表明您已經(jīng)審閱了這份文件，確認它精確并完全的反映任務和可交付使用對< 設備名稱 > 驗證的必要。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感謝下載載reference Validation Master Plan,日期精品姓名，職稱簽名單位Quality Control/Compliance

4、 Approver's Signature:質檢 / 承認簽名Your signature indicates that this document complies with <company standards or guidelines > and that the documentation and information contained herein complies with applicable regulatory, corporate, divisional/departmental requirements, and current Good Man

5、ufacturing Practices.您的簽名表明這份文件符合證明人驗證總計劃，企業(yè)標準或政策，并且在此包含的文件和信息符合可應用的可調整的，共同的以及部門所有的部門的要求和現(xiàn)行的標準。Approved By:經(jīng)核準：Typed/Printed Name, TitleSignatureDateUnit姓名，職稱簽名日期單位Typed/Printed Na me, TitleSignatureDateUnit姓名，職稱簽名日期單位感謝下載載精品Revision History修訂歷史紀錄RevisioRevisionReason for Revision/Change RequestRevi

6、sed BynDate修訂 / 更改要求的原因修訂人修訂本修訂日期004-DEC-Original ReleaseMichael T. Filary2002原始版本邁克爾2002/12/4116-JAN-Updated the JETT logo on the cover page.Michael T. Filary2003更新封頁面的 JETT 的標識邁克爾2003/1/16Table of Contents目錄1.Introduction 緒論 .221.1Purpose 目的 .221.2Policy Compliance適用的政策 .221.3Scope of Validation驗證

7、范圍 .221.4Objectives 目標 .221.5Periodic Review 定期審查 .222.Organizational Structure組織結構 .223.GxP Criticality AssessmentGxP關鍵性評估 .223.1GxP Criticality Assessment - RequirementsGxP關鍵性評估要求 .22感謝下載載精品3.2GxP Criticality Assessment - Procedures GxP關鍵性評估程序223.3GxP Criticality AssessmentCurrent StatusGxP 關鍵性評估現(xiàn)

8、行標準. 224.Validation Strategy驗證策略 .224.1Life Cycle 生命周期.224.2Risk Assessment風險評估 .224.3Hardware Categories硬件分類 .224.4Software Categories軟件分類 .224.5Project Inputs/Outputs for Stages項目各階段的輸入 / 輸出 .224.6Acceptance Criteria for Stages各階段的接受標225.Validation Deliverables.225.1 Traceability and Linkages描述和鏈接

9、225.2Master List of all Validation Products and Supporting Documentation所有批準產(chǎn)品和證明文件的總清單225.3User Requirements Specification (URS)使用說明書 .225.4Functional Requirement Specification (FRS)功能說明書 .225.5Configuration Management and Change Control Documentation配置管理和變速控制文件225.6Vendor Qualification documentati

10、on賣主資格認證225.7Design Specifications設計說明.225.8 Testing and Verification Requirements Documentation試驗和確認所需文件225.9System Security系統(tǒng)安全性 .235.10Operational Support運行支持 .245.11Business Continuity Plan業(yè)務持續(xù)計劃 .245.12Disaster Recovery, Backup and Restoration災難性恢復，備份及修復 .255.13System AcceptanceFinal Report 系統(tǒng)接

11、受 終報告.255.14<List any additional validation products required>列出任何其他需要驗證的產(chǎn)品266.Acceptance Criteria可接受標準 .267.Change Control 變更控制.267.1Pre-Implementation Changes預執(zhí)行變更 .267.2Post-Implementation Changes執(zhí)行后變更.27感謝下載載精品8.Standard Operating ProceduresSOP .278.1SOP ResponsibilitiesSOP 職責 .278.2Listin

12、g of SOPsSOP 列表 .289.Training培訓 .2810.Documentation Management資料管理 .2810.1Document Production文件產(chǎn)生 .2810.2Document Review文件回顧 .2810.3Document Approval文件批準.2910.4Document Issue文件發(fā)布 .2910.5Document Changes文件變更.2910.6Document Withdraw文件撤銷 .2910.7Document Storage文件保存 .2911.Maintaining the Validated State

13、驗證狀態(tài)的維護 .3011.1System Retirement系統(tǒng)引退 .3012.Validation Activities Timeline驗證執(zhí)行時間表 .30Appendix A附錄 A參與組織 .31Appendix B附錄 B縮寫詞，定義 .33Appendix C附錄 C責任 / 時間 .37Appendix D附錄 D可交付的驗證 .39Appendix E附錄 E參考 .41(Reminder of Page Intentionally Left Blank)感謝下載載精品1.Introduction緒論1.1Purpose目的This document, also ref

14、erred to as the Plan, outlines the planned tasks and expectations forvalidation of the <equipmentname>.這份文件，也稱計劃，略述計劃的任務和設備名稱的預期驗證。?WHOwill be responsible for completion, review, and approval of these tasks.? 世界衛(wèi)生組織將負責任務的完成、審閱和批準。?WHATdocumentation/deliverables will be generated and/or retaine

15、d as part of the ValidationPackage(s).?什么文件 / 可交付使用的將會作為驗證包的一部分被產(chǎn)生和/ 或保留。?HOWthis 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 corporate policy requirements for validation as stated in the <refe

16、r to specific Validation Master Plan(s), company policies, company standards,and/or company guidelines >, and the appropriate Appendix of the current revision of GAMP.這份計劃將會遵守在涉及特殊驗證總計劃，公司政策，公司標準和公司指導方針和適當性（現(xiàn)行GAM 附錄）中關于驗證的統(tǒng)一要求。The validation of the <equipment name> system is a cGMP requirem

17、ent.設備名稱的驗證系統(tǒng)是現(xiàn)行的一個要求。1.3Scope of Validation驗證范圍This Validation Plan for the <equipment name> is limited to the unique components andcontrol system that define the equipment. This validation effort will be conducted as a prospective validation.這份為設備名稱的驗證計劃僅限于特殊構成和定義設備的控制系統(tǒng)。該項驗證成就將會被作為一項預期的驗證執(zhí)行

18、。感謝下載載精品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 which the equipment is planned.對用戶必備使用的說明書中的設備和主要功能的闡述 . 對實施計劃的設備進行研究、生

19、產(chǎn)、加工、包裝、存儲、分配過程的說明。1.3.1In-Scope驗證范圍The scope of validation for the <equipment name>includes all the following that arenecessary for the system to operate. <clearly define all boundaries>（設備名稱）驗證的范圍包括以下所有的系統(tǒng)運作所必需的內容。（明確界限）1. Controls system hardware and software控制系統(tǒng)得硬件和軟件2. Mechanical Ha

20、rdware機械的硬件3. Instrumentation儀器4. Process piping輸水管道工藝5. Utility Systems通用系統(tǒng)6. Facility設施7. <list all that are appropriate>其他需要的名單1.3.2Out-of-Scope驗證范圍例外The scope of validation for the <equipment name>does not include:（設備名稱）驗證的范圍不包括：1. The XYZ system is validated separately.感謝下載載精品系統(tǒng)單獨驗證

21、2. The Data Historian is validated separately.數(shù)據(jù)歷史單獨驗證3. <list all that are appropriate>其他名單1.3.3Related Validation相關驗證< 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

22、for test methods or directly replacing tests, if the systems configuration can be shown to be the same now as at the time the data was collected>插入現(xiàn)有的或計劃的與本驗證系統(tǒng)有關的驗證的描述。如果系統(tǒng)配置和數(shù)據(jù)采集時是一致的，前期數(shù)據(jù)的使用可以作為試驗方法的參考或直接替代試驗，The related validation that will occur in support of the <equipment name>includ

23、es all thefollowing that are necessary for the system to be placed into operation. <clearly define allboundaries>支持（設備名稱）的相關驗證在以下情況發(fā)生：包括系統(tǒng)運行必需的幾點（清晰的定義分界線）：1. Process Validation工藝驗證2. Cleaning Studies清潔研究3. Air Classification風力分級4. Microbiological Testing微生物試驗5. Chemical Testing化學試驗6. Drying S

24、tudies感謝下載載精品干燥研究7. Sterilization Studies無菌研究8. <list all that are appropriate>其他名單1.4Objectives目標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 n

25、ame>are appropriate for cGMP-regulated processes. The qualificationsoutlined are to be based on < company name > policies and procedures and applicable regulations, guidelines, and accepted industry practices for validation.該項驗證計劃的目標是簡述一項要求，該要求能夠證明所有與設備名稱相關的組成、控制系統(tǒng)和功能都是恰當?shù)姆犀F(xiàn)行標準的工藝。資格的綜述要基于

26、（公司名稱）政策，程序以及可應用的規(guī)則、指導方針和公認的工業(yè)驗證實踐。1.5Periodic Review定期回顧This Plan should be reviewed periodically to ensure compliance and or to determine if achange is required. Some appropriate times to review are:這份計劃應該被定期回顧來保證符合并確定是否需要更改。一些適當?shù)幕仡檿r間是：1.Change in Validation Master Plan驗證主文件的更改發(fā)生時2.Change in scope

27、 occurs驗證范圍的更改發(fā)生時3.Design change occurs設計更改發(fā)生時4.Prior to IQ and OQ在進行和之前5.Completion of IQ and OQ和完成時See 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.感謝下載載精品見第五部分有關驗證管理和針對該項計劃的回顧、修訂

28、過程或指適應公司政策的回顧周期。2. Organizational Structure組織結構Specific responsibilities related to the validation of the< equipment name> are outlined inAppendix A. In general, the activities associated with this project, are the responsibility of thefollowing individuals and groups:與（設備名稱）驗證相關的具體職責在附錄中概述。大體

29、上，與驗證相關的活動項目由以下個人和部門負責：<The defined role and responsibilities should include at a minimum the individuals listed below - Describe each role and responsibility in a general way as they apply>確定個人的任務和責任至少應包括以下幾點，總體根據(jù)崗位不同描述每項任務和責任1. Management levelResponsible for project management and planning,

30、 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 approvingvalidation documentation for the project管

31、理層：負責項目管理和計劃。方案，活動，資源，成本的控制，監(jiān)控工藝，2. Quality AssuranceResponsible for assuring compliance with appropriateregulatory/business/technical/user community requirements, providing support for the criterion/independent review/approval of deliverables, approving completion ofstage/validation status質保：負責保證符合

32、適當?shù)恼{整、商業(yè)、技術、用戶群要求，支持維護標準、獨立審查、可交付的批準、審批完成階段和身份驗證等。3. System Owner Responsible for implementation/management of the system by thebusiness user community, approving completion of stage/validation status系統(tǒng)所有者：負責執(zhí)行和管理系統(tǒng)的用戶群，審批完成階段和驗證身份。<These role and responsibilities may be defined as appropriate -

33、Describe each role andresponsibility in a general way as they apply>這些任務和責任可以適當?shù)亩x：按照他們的分工總體上定義每項任務和責任。1.OperationsResponsible for providing操作：負責提供 感謝下載載精品2.Project LevelResponsible for providing項目水平：負責提供 3.Technical and Engineering supportResponsible for providing技術和工程支持：負責提供 4.Validation Specia

34、listResponsible for providing驗證專家：負責提供 5.System AdministratorResponsible for providing系統(tǒng)管理：負責提供 6.Purchasing - Responsible for providing采供：負責提供 7. <List all that are appropriate>其他名單3.GxP Criticality AssessmentGxP 關鍵性估計Detail the GxP criticality assessment information related to the< equipm

35、ent name> .This section may reference another source of information covering this topic, such as a system inventory.詳述和（設備名稱）有關的GxP 關鍵性估計信息。該部分包括另外一種信息，包括該主題，例如系統(tǒng)詳細目錄。3.1GxP Criticality AssessmentRequirementsGxP 關鍵性評估要求Define the requirements used in the determination of the levels for GxP critic

36、ality for the< equipment name>.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（設備名稱） Gxp 水平中使用的關鍵性要求，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 operation, contact, da

37、ta, 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)品質量有直接影響的操作，接觸，控制，預警或失敗。感謝下載載精品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. Indirect

38、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)品質量無直接影響的操作，接觸，控制，預警或失敗。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)行和運作構成影響。No Impact System or component within a system where

39、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)品質量不構成直接或間接影響的操作，接觸，控制，預警或失敗。無影響系統(tǒng)不能支持直接影響系統(tǒng)。3.2GxP Criticality AssessmentProceduresGxP 關鍵性評估 - 程序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 levelsfor GxP criticality for each item associated with t