【正文】 re critical to product and patient safety?? 系統(tǒng)的哪個方面或工藝對產(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)的哪個方面或工藝過程對商業(yè)是關(guān)鍵性因素? Categories硬件分類Define the categories of the hardware associated with the equipment name. 定義(設(shè)備名稱)的硬件種類Hardware ponents 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 2 – Custom Built Hardware Components? 硬件分類 2：定制的硬件組成 Categories軟件分類Define the categories of the software associated with the equipment name. Company Logo DOCUMENT NUMBER: PAGE:16 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定義(設(shè)備名稱)的軟件種類Software ponents 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 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 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 equipment name. 詳述（設(shè)備名稱）的相關(guān)項(xiàng)目各階段的接受標(biāo)準(zhǔn)。 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 prise the Validation Package. The Plan 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.Company Logo DOCUMENT NUMBER: PAGE:17 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。Company Logo DOCUMENT NUMBER: PAGE:18 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 and Linkages描述和鏈接This document links the URS, FRS, Design Specifications and the Testing Specifications (IQ, OQ, PQ) per the VModel 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 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 Requirements Specification (URS) 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. 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。User RequirementsSpecification 使用要求 FunctionalSpecificationsDesign SpecificationsPerformance QualificationOperational QualificationInstallation QualificationBuild SystemVerifies 證實(shí)Verifies 證實(shí)Verifies 證實(shí)Company Logo DOCUMENT NUMBER: PAGE:19 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 Requirement Specification (FRS) 功能說明書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 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. 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 postimplementation changes. Documents that require change control may include any of the 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。 Qualification documentation賣主資格認(rèn)證Provide documentation that verifies that vendor(s) are qualified, petent 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 Specifications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 Flow Diagrams流程表數(shù)據(jù)4. Process Flow Diagrams工藝流程數(shù)據(jù)5. System architecture draCompany Logo DOCUMENT NUMBER: PAGE:20 of 56LOCATION: Revision: Rev EFFECTIVE: TITLE: VALIDATION PLAN FOR THE Equipment Name, ID 12