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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。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。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。
The overall verification process can be divided into 5 nodes, namely planning, development/configuration, confirmation, maintenance, and retirement. The first thing we need to do during the planning phase is to evaluate whether the computerized system will have a direct, indirect, or no impact on my current operating methods and products. This evaluation is similar to the business justification in the project. User requirements are the requirements for the computerized system I want to choose, including installation, operating environment, security, functionality, application, specifications, etc. They should be considered and form the foundation of the entire computerized system. All subsequent confirmations will come from this document. Supplier audit, I believe every enterprise also has relevant procedures, so I won't go into too much detail here. The validation plan, as mentioned earlier, is important to repeat that the plan should be implemented and executable.
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。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。
Functional specifications and design specifications are the basic documents of the entire computerized system provided by suppliers in accordance with the requirements documents. Enterprises should review these documents and, if necessary, request third-party organizations to review them. During the development and configuration stages, most enterprises are no longer able to conduct supervision. Therefore, when auditing suppliers, special attention should be paid to those with inadequate quality management systems, which should be listed as high-risk items.
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。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。
In the confirmation stage, I believe everyone is quite familiar with it. I just want to emphasize that before the OQ report, the necessary SOP files for the operation of the relevant system should be completed and validated. The maintenance phase is mainly used to ensure the good operation of the system, and PQ is also ongoing 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。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。
In the retirement stage, the main goal is to ensure that after the system is replaced, historical data is still retained in accordance with regulatory requirements. Risk assessment is conducted throughout the entire process, and each stage should undergo risk assessment and response, which is consistent with risk management in the project. Risk may not be completely eliminated, but it can be reduced through various means of control.
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This article is provided by a computerized system validation company for assistance. For more related content, please click on https://www.fmkgmp.com I hope this article can be helpful to you. Thank you for reading!