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验证整体流程可以分为5个节点，分别为计划、开发/配置、确认、维护、退役。计划阶段我们首先要做的就是评估，评估上这套计算机化系统之后对我现在的操作方式的影响以及对产品的影响，是直接、间接还是无影响。这个评估类似项目中的商业论证。
The overall verification process can be divided into five nodes: planning, development / configuration, confirmation, maintenance and decommissioning. At the planning stage, the first thing we need to do is to evaluate whether the impact of this computerized system on my current operation mode and the impact on the product is direct, indirect or no. This evaluation is similar to the business demonstration in the project.
用户需求：是对我想要选择的这个计算机化系统的要求，包括安装、运行环境、功能、应用、规范等的要求，应具有可考量性，是整个计算机化系统的基础，后续的所有确认均来自这份文件。
User requirements: the requirements for the computerized system I want to select, including the requirements for installation, operating environment, functions, applications, specifications, etc., should be considered, which is the basis of the whole computerized system. All subsequent confirmations come from this document.
供应商审计：每个企业也都有相关的规程。验证计划：之前也提到了，就是计划应当落地，应当有可执行性。功能规格、设计规格，这些都是供应商按照需求文件提供的整个计算机化系统的基本文件，企业应当对这些文件进行审核，必要时可请第三方机构进行审核。
Supplier audit: each enterprise also has relevant procedures. Verification plan: as mentioned earlier, the plan should be implemented and executable. Functional specifications and design specifications are the basic documents of the whole computerized system provided by the supplier according to the requirements documents. The enterprise shall review these documents and ask a third-party organization to review them if necessary.
开发和配置阶段：一般企业基本上已经无法进行监管，因此在供应商审计时应当着重考量，对于供应商质量管理体系不健全的，应当列为高风险项。在确认阶段，OQ报告之前，应当完成相关系统运行所需的SOP文件的生效。维护阶段，主要是用来保证系统的良好运行，而PQ也同步在继续进行，用于证明系统的良好运行。
Development and configuration stage: general enterprises are basically unable to supervise, so they should pay attention to supplier audit. If the supplier's quality management system is not perfect, it should be listed as a high-risk item. In the confirmation stage, before OQ report, the effectiveness of SOP documents required for relevant system operation shall be completed. The maintenance phase is mainly used to ensure the good operation of the system, and PQ is also carried out synchronously to prove the good operation of the system.
退役阶段：主要的是保证系统被替代后，历史数据仍按照法规要求继续保留。风险评估是全程进行的，每个阶段都应当进行风险评估以及响应，这个和项目中的风险管理是一致的。
Decommissioning stage: the main thing is to ensure that after the system is replaced, the historical data will continue to be retained in accordance with the requirements of laws and regulations. Risk assessment is carried out in the whole process, and risk assessment and response should be carried out at each stage, which is consistent with the risk management in the project.
风险不会完全消失，但可通过各种方式的控制以达到风险的降低。以上，是我对流程的简单的描述，其中有两项需求跟踪矩阵。其面向的对象不一样，一个需求跟踪矩阵主要是URS-FS-DS直接的响应或者说对应关系，而另一个需求跟踪矩阵则加入了TC，即测试用例的对应关系。表明每一个URS点是如何进行确认。
The risk will not disappear completely, but it can be controlled in various ways to reduce the risk. The above is my brief description of the process, including two requirements tracking matrices. Its object-oriented is different. One requirement tracking matrix is mainly the direct response or correspondence of urs-fs-ds, while the other requirement tracking matrix adds TC, that is, the correspondence of test cases. Indicate how each urs point is confirmed.
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