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言归正传。随着这几年监管的严格以及越来越多数据完整性方面的检查发现项，制药企业也越来越关注这方面的问题，越来越多的QA，工程设备验证组，或者独立的验证部门开始分出了计算机化系统验证业务，以应对法规及监管的要求。
get down to business. With the strict supervision and more and more data integrity inspection findings in recent years, pharmaceutical enterprises have also paid more and more attention to this issue. More and more QA, engineering equipment verification teams, or independent verification departments have started to separate out the computerized system verification business to meet the requirements of regulations and supervision.
但是，在实际上，既了解质量管理系统QMS，有了解软件系统开发生命周期，还了解数据完整性（纸质及电子）/数据重要程度分类/数据载体分类/数据流梳理，还懂GEP工程技术，甚至了解工艺及业务逻辑流程，懂IT的一些个方法及要求（备份，归档，迁移等等）的人。
However, in fact, people who understand not only the quality management system QMS, but also the software system development life cycle, data integrity (paper and electronic)/data importance classification/data carrier classification/data flow sorting, GEP engineering technology, even the process and business logic process, and some methods and requirements of IT (backup, archiving, migration, etc.).
实在是寥寥无几…大部分人停留在计算机化系统只是几个权限账户的配置/审计追踪测试/备份还原测试等初级水平，既不懂CSV体系，又不会差距分析及整改，不知其所以然，所以暴露了一系列的问题。今天我只是想介绍下我对这方面的浅薄认知，如果对大家能有所帮助，则我的愿望也实现了。
It's really very few... Most people stay at the primary level of the computerized system, such as the configuration/audit trail test/backup and restore test of a few privilege accounts. They don't understand the CSV system, nor do they know the gap analysis and rectification. They don't know why, so they expose a series of problems. Today I just want to introduce my shallow understanding of this aspect. If it can help you, my wish will be realized.
其实，CSV与数据完整性，是有着互相影响作用的关系的，CSV属于验证中的一块。很多验证工程师连验证分哪几块都不是很明确（验证的类别，从药品从生产前的前提条件人机料法环准备，到生产过程如工艺验证，清洁验证及持续工艺确认，过程检验以及成品检验如分析仪器及分析方法学，再到生产后的稳定性考察及运输确认，还需要进行验证状态回顾等等），一直低着头在自己的领域“埋头苦干”，不能跳出自己的领域，从更高的高度看问题，自然就会少了很多风景。验证也只是诸多QMS章节中的一块，验证/确认/校准等，其实也是为了数据完整性提供证据，很大程度服务的是CMA（关键物料属性），CPP（关键工艺参数），IPC（过程控制），CQA（关键质量属性）。
In fact, CSV and data integrity have an interactive relationship. CSV is a part of validation. Many validation engineers are not very clear about which parts of the validation should be divided (the type of validation, from the preparation of human, material, method and environment before the production of drugs, to the production process such as process validation, cleaning validation and continuous process validation, process inspection and finished product inspection such as analytical instruments and analytical methodology, to the stability inspection and transportation confirmation after production, and also need to review the validation status, etc.), Keep your head down and "work hard" in your field. You can't jump out of your field. If you look at the problem from a higher level, you will naturally lose a lot of scenery. Verification is only one part of many QMS chapters. Verification/validation/calibration is also to provide evidence for data integrity. To a large extent, it serves CMA (key material attribute), CPP (key process parameter), IPC (process control) and CQA (key quality attribute).
后续，我将陆续回答我对文章最前面提出的那些个问题的看法和理解，并结合实际，来和大家一起慢慢认识计算机化系统验证CSV（其实是数据完整性DI）。
Later, I will continue to answer my views and understanding of the questions raised at the beginning of the article, and combine with reality to slowly understand the computerized system verification CSV (actually data integrity DI) with you.