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计算机化系统附录里说得很清楚，附录适用的范围是药品生产质量管理过程中应用的计算机化系统，也就是说计算机化系统是否与GMP相关是计算机化系统是否需要进行系统验证的依据。
It is clearly stated in the Computerized System Appendix that the scope of application of the appendix is the computerized system used in the quality management process of drug production, which means that whether the computerized system is related to GMP is the basis for whether the computerized system needs to undergo system validation.
很多企业在上计算机化系统前往往只是跟风，并没有真正定义清楚系统是干什么用的，甚至上了很高大上的系统，还在用很原始的方式处理数据，处理出的结果有可能与计算机系统得出的结论还不一致；更有甚者主动不采用系统的自动化功能，保留着手工操作工艺设备的“优良传统”。
Many enterprises often just follow the trend before using computerized systems, without really defining what the system is used for. Even if they use very tall systems, they still process data in a very primitive way, and the results may not be consistent with the conclusions drawn by the computer system; Even more, they actively do not use the automation functions of the system, and retain the "excellent tradition" of manually operating process equipment.
这些企业可要小心了，GMP附录里明确要求“企业应当建立包含药品生产质量管理过程中涉及的所有计算机化系统清单，标明与药品生产质量管理相关的功能，清单应当及时更新”。计算机化系统是干什么用的，支持什么样的GMP活动不能再是一笔糊涂帐了。监管者根据这个条款的要求检查其实是很容易的，要求企业提供计算机化系统的清单，从清单中选择一些关键的系统，检查其项目实施阶段的文件、系统运维阶段的支持性文件、操作文件，顺藤摸瓜再去查查系统的数据是否存在完整性问题，基本上就可以通过这看出企业管理体系水平的高低了。
These enterprises should be careful. The GMP appendix clearly requires that "enterprises should establish a list of all computerized systems involved in the process of drug production quality management, indicating the functions related to drug production quality management, and the list should be updated in a timely manner.". "What a computerized system is for and what kind of GMP activities it supports cannot be confused anymore.". According to the requirements of this clause, it is actually very easy for regulators to check. They require enterprises to provide a list of computerized systems, select some key systems from the list, check the documents in the project implementation stage, supporting documents in the system operation and maintenance stage, and operation documents. After that, they can check whether there are integrity issues in the system data. This can basically indicate the level of the enterprise management system.
哪些叫做GMP活动，需要你去翻一翻2010版GMP了，哪些是质量体系（这里的质量体系是指广义的质量体系）的要求，如果这些活动是由计算机化系统支持的，那这些系统就需要验证。
What are called GMP activities? You need to go through the 2010 version of GMP and what are the requirements of the quality system (here, the quality system refers to the generalized quality system). If these activities are supported by computerized systems, these systems need to be validated.
最后，结合FDA的六大系统举例说明一下哪些是需要验证的计算机化系统：
Finally, combined with the six FDA systems, the following examples are given to illustrate which computerized systems need to be validated:
生产系统
production system
自动化工艺设备，工艺设备监视与数据采集系统，称量系统，自动在线清洁、在线灭菌系统等
Automatic process equipment, process equipment monitoring and data acquisition system, weighing system, automatic online cleaning, online sterilization system, etc
包装及标签说明书管理系统
Packaging and labeling instructions management system
电子监管码系统，说明书版本管理系统，包装管理系统等
Electronic supervision code system, manual version management system, packaging management system, etc
厂房设备及工艺设备系统
Plant equipment and process equipment system
校准管理系统，预防性维护计划系统，设备图纸管理系统等
Calibration management system, preventive maintenance planning system, equipment drawing management system, etc
物料系统
Material system
供应商管理系统，物料仓储状态管理系统，仓库温度监视系统等
Supplier management system, material storage status management system, warehouse temperature monitoring system, etc
实验室系统
Laboratory system
实验室自动化分析设备，灭菌设备等
Laboratory automated analysis equipment, sterilization equipment, etc
狭义的质量管理系统
Quality management system in a narrow sense
文档审批管理系统，变更偏差投诉管理系统，培训管理系统，ERP系统（涉及产品放行）
Document approval management system, change deviation complaint management system, training management system, ERP system (involving product release)
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