封面图
正文内容
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, including planning, development / configuration, confirmation, maintenance and retirement. The first thing we need to do in the planning stage is to evaluate whether the impact of this computerized system on my current operation mode and on the product is direct, indirect or no impact. 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、安全、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。供应商审计，这个相信每个企业也都有相关的规程，这里就不啰嗦了。
User requirements are the requirements for the computerized system I want to choose, including the requirements for installation, operating environment, safety, functions, applications, specifications, etc., which should be considered and are the basis of the entire computerized system. All subsequent confirmations come from this document. I believe that every enterprise also has relevant procedures for supplier audit, so I won't be wordy here.
验证计划，之前也提到了，重要的重复一遍，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。
As mentioned earlier, it is important to repeat that the plan should be implemented and enforceable. The 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 should 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，相信大家都比较熟悉了，在此只想说明一点，就是OQ报告之前，应当完成相关系统运行所必须的SOP文件的生效。
In the development and configuration stage, general enterprises are basically unable to supervise, so they should pay attention to supplier audit, and those suppliers with imperfect quality management system should be listed as high-risk items. In the confirmation stage, I believe everyone is familiar with it. I just want to make one point here, that is, before OQ report, SOP documents necessary for relevant system operation should be completed to take effect.
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。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。
The maintenance phase is mainly used to ensure the good operation of the system, and PQ is also continuing synchronously to prove the good operation of the system. In the retirement stage, the main thing is to ensure that the historical data will continue to be retained in accordance with the requirements of the regulations after the system is replaced.
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。风险不会完全消除，但可通过各种方式的控制以达到风险的降低。
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. The risk will not be completely eliminated, but it can be controlled in various ways to reduce the risk.
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，第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，而第二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。法默康可以为您提供专业的计算机化系统验证咨询服务https://www.fmkgmp.com
The above is my brief description of the process, including two requirements tracking matrices. Its object-oriented is different. The first requirement tracking matrix is mainly the direct response or correspondence of urs-fs-ds, while the second requirement tracking matrix adds TC, that is, the correspondence of test cases. Indicate how each urs point is confirmed. Famocom can provide you with professional computerized system verification consulting services https://www.fmkgmp.com