【文章內(nèi)容簡介】 OR THE Equipment Name, ID 12345File Name: Last Save Date: 029 月2022Print Date: 8/21/22161 月2022 InScope　　　　驗證范圍　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）驗證的范圍包括以下所有的系統(tǒng)運作所必需的內(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. 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 OutofScope　　　　　驗證范圍例外The scope of validation for the equipment name does not include:（設(shè)備名稱）驗證的范圍不包括：1. The XYZ system is validated separately.ＸＹＺ系統(tǒng)單獨驗證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Company Logo DOCUMENT NUMBER: PAGE:9 of 56LOCATION: Revision: Rev EFFECTIVE: TITLE: VALIDATION PLAN FOR THE Equipment Name, ID 12345File Name: Last Save Date: 029 月2022Print Date: 8/21/22161 月2022 Related Validation　　　　相關(guān)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 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(guān)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 includes all the following that are necessary for the system to be placed into operation. clearly define all boundaries支持（設(shè)備名稱）的相關(guān)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(fēng)力分級4. Microbiological Testing微生物試驗5. Chemical Testing化學(xué)試驗6. Drying Studies干燥研究7. Sterilization Studies無菌研究8. list all that are appropriate其他名單 Objectives　　目標(biāo)The objective of this validation plan is to outline the requirements that will demonstrate and document that all ponents, control system(s) and functionality associated with the equipment name are appropriate for Company Logo DOCUMENT NUMBER: PAGE:10 of 56LOCATION: Revision: Rev EFFECTIVE: TITLE: VALIDATION PLAN FOR THE Equipment Name, ID 12345File Name: Last Save Date: 029 月2022Print Date: 8/21/22161 月2022cGMPregulated processes. The qualifications outlined are to be based on pany name policies and procedures and applicable regulations, guidelines, and accepted industry practices for validation.該項驗證計劃的目標(biāo)是簡述一項要求，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ＧＭＰ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)驗證實踐。 Periodic Review定期回顧This Plan should be reviewed periodically to ensure pliance and or to determine if a change is required. Some appropriate times to review are:這份計劃應(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 驗證主文件的更改發(fā)生時2. Change in scope occurs 驗證范圍的更改發(fā)生時3. Design change occurs 設(shè)計更改發(fā)生時4. Prior to IQ and OQ　 在進(jìn)行ＩＱ和ＯＱ之前5. Completion of IQ and OQ　 ＩＱ和ＯＱ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.見第五部分有關(guān)驗證管理和針對該項計劃 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 responsibilities 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）驗證相關(guān)的具體職責(zé)在附錄Ａ中概述。大體上，與驗證相關(guān)的活動項目由以下個人和部門負(fù)責(zé)：The defined role and responsibilities should include at a minimum the individuals listed below Describe each role and responsibility in a 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，總體根據(jù)崗位不同描述每項任務(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/project objectives are correctly addressed/resolved, reporting to senior management, interface to QA to ensure pliance, reviewing and approving validation documentation for the project…管理層：負(fù)責(zé)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 Assurance – Responsible for assuring pliance with appropriate Company Logo DOCUMENT NUMBER: PAGE:11 of 56LOCATION: Revision: Rev EFFECTIVE: TITLE: VALIDATION PLAN FOR THE Equipment Name, ID 12345File Name: Last Save Date: 029 月2022Print Date: 8/21/22161 月2022regulatory/business/technical/user munity requirements, providing support for the criterion/independent review/approval of deliverables, approving pletion 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)、獨立審查、可交付的批準(zhǔn)、審批完成階段和身份驗證等。3. System Owner – Responsible for implementation/management of the system by the business user munity, approving pletion 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 Criticality AssessmentGxP 關(guān)鍵性估計Detail the GxP criticality assessment information related to the equipment name. 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。 Company Logo DOCUMENT NUMBER: PAGE:12 of 56LOCATI