计算机化系统

这是一篇关于计算机化系统的思维导图，包括概念的提出、项目实施、系统运行、系统退役等，每个步骤进行了详细的说明。

计算机化系统 computerized system

• 概念提出 Concept proposal
  • 基于业务流程，确定是否进入计算机化系统的实施阶段 Determine whether to enter the implementation stage of computerized system based on business process
• 项目实施 project implementation
  • 计划 plan
    • 质量项目计划 Quality project plan
  • 风险管理 risk management
    • 考虑到患者安全、数据完整性及产品质量，计算化系统的整个生命周期都应遵循风险管理原则。并以风险评估为基础，来确定验证范围和数据完整性的控制策略 In consideration of patient safety, data integrity and product quality, the entire lifecycle of computerized system should follow risk management principles. The validation scope and data integrity control strategy are determined based on the risk assessment.
  • 规范 standard
    • URS用户需求规范
      • 供应商审计 Supplier Audit
      • 用户需求的进一步制定 URS
        • 背景介绍 Background introduction
          • 简述开发本系统的原因、资质、放置位置、所需的技术和质量要求及原则等内容。 briefly describe the reasons, qualifications, position, technical and quality requirements and principles, needed to develop this system.
        • 目的范围 Objective scope
          • 说明该系统的目的、要求范围。 explain the objective, requirement and extent of scope of this system.
        • 系统说明 System specification
          • 说明全系统要做什么、控制方式、执行的过程、操作人员对接口的要求及安全性要求等 describe what the full system needs to do, the control mode, the execution process, the operator's interface requirements and security requirements
  • 配置和/或编程 Configuration and / or programming
    • 功能说明 FS
      • 设计说明 DS
        • 使用详细的技术语言来描述如何开发设备才能提供用户需要的功能。 uses detailed technical language to describe how the device can be developed to provide the functionality that users need.
      • 硬件设计说明 HDS
        • 硬件设计说明应包括图纸、流程图、手册、部件清单、电路图、打印机、人机界面面板、显示器和屏幕。 Hardware Design Specification (HDS): HDS shall include drawings, flow charts, manuals,parts list, wiring diagrams, printers, human interface panels, displays and screens.
      • 软件设计说明 SDS
        • 基于ISPE GAMP5的软件分类 Software classification based on ISPE GAMP5
          • 基础设施软件 Infrastructure software
          • 不可配置软件 Non configurable software
          • 可配置的软件 Configurable software
            • 软件模块说明 Description of software modules
          • 编程的软件 coding of the software
            • 源代码审核 Source code review
  • 验证 validations
    • 工厂/现场验收测试 FAT/SAT
      • 设计确认 DQ
        • 设计确认的目的是为了证明所有设计文件已经被批准（设计阶段已完成）。设 计过程有记录并完全可追溯，满足用户需求。 The purpose of Design Qualification is to verify that all design documents have been approved (design phase completed). The design process is recorded and fully traceable and can meet all user requirements
      • 安装确认 IQ
        • 安装确认的内容以风险评估为依据 The IQ content should be based on the Risk Assessment
        • 安装确认目的是保证系统的安装符合设计标准，并保证所需技术资料俱全。 The objective of IQ is to ensure that the system installation conforms to the design standard and all the required technical information is available.
      • 运行确认 OQ
        • IQ完成是OQ开始的前提 The OQ of the computer system shall only be carried out on the premise that the IQ is correctly completed and conforms to all requirements.
        • 运行确认的内容以风险评估为依据 The OQ content should be based on the Risk Assessment
        • 运行确认目的是确认系统在既定的限度和容许范围内能够正常运行。The purpose of Operation Qualification is to confirm that the system can operate normally within the established limits and tolerances.
      • 性能确认 PQ
        • 在实际生产过程中进行，通常与工艺验证或系统/设备性能确认一起执行。 This phase of testing needs to be done in the actual user or production environment or one that will become the actual production environment. Itis usually implemented together with Process Validation or System/Equipment Performance Qualification
        • 已经有可以使用的SOP There are already SOPs that can be used
        • 输出总结报告 Validation Summary Report
  • 报告
• 系统运行 System operation
  • 阶段最长，有既定的、及时更新的、可操作的规程进行管理 Stage longest with established, timely updated, actionable protocols for management
  • 需要保证系统的受控 Need to guarantee system control
  • 符合预期用途并满足法规要求 Compliance with intended use And to meet regulatory requirements
    • 数据备份 Data backup
      • 工控部备份 Work control department backup
      • 其他数据 add data
      • 数据导出 Data export
      • 介质管理 Backup media management
    • 时钟管理 Clock management
    • 权限管理 Authority management
      • 三级权限管理 Three levels limits of authority management
      • windows管理 Windows management
      • 其他无审计追踪的设备管理 Other device management without audit trail
    • 安全管理 security management
      • 构架管理 Architecture management
  • 系统的改变伴随变更和配置管理 Changes to the system accompanied change and configuration management
    • 变更控制流 Change control stream
• 系统退役 System decommissioning
  • 计算机化系统功能不再适用 Computerized system features are no longer applicable
  • 有新的系统进行替代 There are new systems for substitution
  • 系统的退役要保留原系统中取回数据的方法 Decommissioning of systems to preserve methods for retrieving data from the original system