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先来思考几个基本问题：1.什么是计算机系统？2.什么是计算机化系统？3.什么是验证？4.验证Validation，确认Qualification，查证Verification之间的关系？5.什么是计算机化系统生命周期？6.计算机化系统验证与生命周期的关系？7.计算机化系统验证CSV与质量管理系统QMS的关系？8.什么是数据完整性？什么是ALCOA+？计算机化系统验证与数据完整性的关系？9.数据管理的方法与原则？数据分类及其载体系统的分类？10.差距分析与整改？长期治理？11. 终回归至业务流程设计 ？
Let's consider some basic questions first: 1. What is a computer system? 2. What is a computerized system? 3. What is validation? 4. Verify validation, confirm qualification, and verify the relationship between verifications? 5. What is the life cycle of computerized system? 6. What is the relationship between computerized system verification and life cycle? 7. The computerized system verifies the relationship between CSV and quality management system (QMS)? 8. What is data integrity? What is Alcoa +? What is the relationship between computerized system verification and data integrity? 9. Methods and principles of data management? Data classification and classification of its carrier system? 10. Gap analysis and rectification? Long term governance? 11. Return to business process design?
如果能回答以上问题，那其实也不需要看我这篇“废话”了。由于大众的基础参差不齐，我多也就是普及一下基本知识，且这些知识也会随着我自身的学习与实践而不断提升。有些观点可能是不全面甚至是错误的，希望大家能帮忙提出，一起改进，给更多的领域相关人员作参考。
If you can answer the above questions, you don't need to read my "nonsense". Due to the uneven foundation of the public, I usually popularize the basic knowledge, and these knowledge will continue to improve with my own learning and practice. Some views may be incomplete or even wrong. I hope you can help put forward them, improve them together, and give reference to more relevant personnel in the field.
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 set up computerized system verification businesses to meet the requirements of laws and regulations.
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，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。
However, in fact, people who understand not only the quality management system (QMS), but also the software system development life cycle, but also the data integrity (paper and electronic) / data importance classification / data carrier classification / data flow sorting, and also the GEP engineering technology, even the process and business logic process, and some of the IT methods and requirements (backup, archiving, migration, etc.), Very few... Most people stay at the primary level of the computerized system, such as the configuration / audit tracking test / backup and restore test of only a few privilege accounts. They do not understand the CSV system, nor do they know the gap analysis and rectification. They do not know why, so a series of problems have been exposed. 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。另，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 verification. Many validation engineers are not very clear about which part of the validation is divided (the type of validation, from the preparation of human-machine, 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 the review of validation status is also required), Always keep your head down and "work hard" in your own field. If you can't jump out of your own field and look at problems from a higher level, you will naturally lose a lot of scenery. In addition, verification is only one part of many QMS chapters. In fact, verification / confirmation / calibration is also to provide evidence for data integrity. To a large extent, it serves CMA (key material attributes), CPP (key process parameters), IPC (process control), and CQA (key quality attributes).
后续，我将陆续回答我对文章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）。
Subsequently, I will answer my opinions and understandings on the questions raised earlier in the article one by one, and in combination with the actual situation, I will slowly understand the computerized system verification CSV (actually data integrity DI).
补充一句：CSV终其实是回归Business Process Design (这个相对较复杂，涉及到业务逻辑流程与系统架构，线下与线上流程，系统与其他系统对接等等)
Add: CSV is actually a return to business process design (this is relatively complex, involving business logic process and system architecture, offline and online processes, system and other systems docking, etc.)
以上就是为大家介绍的有计算机化系统验证公司的详细的介绍,希望对您有所帮助.如果您有什么疑问的话,欢迎联系我们.我们将以专业的态度,为您提供服务https://www.fmkgmp.com
The above is the detailed introduction of the computerized system verification company. I hope it will help you. If you have any questions, please contact us. We will provide you with services in a professional manner https://www.fmkgmp.com