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所谓的计算机系统，可以简单理解为控制系统，即由硬件和软件(包括固件--所谓固件就是带程序的硬件，比如带驱动的U盘)组成的，用于控制的部分。而在计算机系统的基础上，再增加控制功能或流程控制(包括操作程序如生产配方，分析方法，SOP等；通过培训有资质的人员；以及设备，比如用电脑控制离心机干活，则离心机就是设备，电脑就是控制系统)，则形成了计算机化系统
The so-called computer system can be simply understood as a control system, which is the part composed of hardware and software (including firmware - firmware refers to hardware with programs, such as USB drives with drivers) used for control. On the basis of computer systems, adding control functions or process control (including operating procedures such as production formulas, analysis methods, SOPs, etc.; training qualified personnel; and equipment, such as using a computer to control a centrifuge for work, the centrifuge is the equipment, and the computer is the control system) forms a computerized system
对于制药GMP相关的计算机系统大致可以分为：IT类系统(根据GAMP 5分类，分为3/4/5类，包括IT应用软件如QMS，和复杂的IT基础设施如常用于备份的软件Acronis)，IT基础设施(GAMP5的1类，这里指的是与GMP相关的IT基础设施而不包括公用办公室相关部分，包括所有GMP系统通用的软硬件如服务器，数据库，硬盘，机房，网络，路由器，防火墙，时间服务器，网络打印机等等；也包括某一计算机化系统专用的基础设施如单独配置了操作系统、电脑、网络等。
For computer systems related to pharmaceutical GMP, they can be roughly divided into: IT systems (classified into 3/4/5 categories according to GAMP 5, including IT application software such as QMS, and complex IT infrastructure software such as Acronis commonly used for backup), IT Infrastructure (GAMP5 Category 1) refers to the IT infrastructure related to GMP and does not include public office related parts, including all software and hardware commonly used in GMP systems such as servers, databases, hard drives, computer rooms, networks, routers, firewalls, time servers, network printers, etc.; it also includes infrastructure specific to a computerized system such as separately configured operating systems, computers, networks, etc.
两者从技术上看区别不大，只是前者通常包含在基础设施的确认里已经完成确认工作了，在后续用到该基础设施的GMP计算机化系统的验证时通常只需要记录即可；而后者因为是专用的，通常包含在GMP计算机化系统的验证中)；分析仪器(根据USP 1058进行分类与确认。
There is not much technical difference between the two, but the former is usually included in the confirmation of the infrastructure and has already completed the confirmation work. In the subsequent verification of the GMP computerized system using the infrastructure, only records are needed; The latter is usually included in the validation of GMP computerized systems as it is specialized; Analytical instruments (classified and confirmed according to USP 1058).
注意：分析仪器这类简单的仪器，做的是确认，而不是验证。只有涉及到复杂流程的系统，以及工艺和方法等，才叫验证)；GMP Excel电子表格(主要有三种形式：单次计算表格，台账类表格，多次反复使用表格)。
Note: Simple instruments such as analytical instruments perform validation, not validation. Only systems that involve complex processes, as well as processes and methods, are called validation; GMP Excel spreadsheets (mainly in three forms: single calculation tables, ledger tables, and repeated use of tables).