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正文内容
计算机系统：包含一个或多个计算机和相关软件的系统。
Computer system: A system containing one or more computers and related software.
计算机化的系统：计算机化的系统包括硬件、软件和网络组件，以及控制功能和相关文件。
Computerized system: Computerized system includes hardware, software and network components, as well as control functions and related documents.
商业(不可配置，即3类软件；可配置的，即4类软件)计算机化的系统：根据市场需要开发的，使用的软件被广泛的商业用户所证明。
Commercial (non configurable, i.e. Category 3 software; configurable, i.e. Category 4 software) computerized system: developed according to market needs, and the software used has been proved by a wide range of commercial users.
内部开发的(定制的，即5类软件)计算机化的系统：为客户生产的系统，专门用于订购，以满足在用户需求规格中设定的一组明确的用户需求。
Internally developed (customized, i.e., Category 5 software) computerized system: a system produced for customers, specifically for ordering, to meet a set of clear user requirements set in the user requirements specification.
黑盒验证：它的源代码或设计对用户来说是未知的。从计算机系统或计算机系统用户的角度进行验证。
Black-box verification: its source code or design is unknown to users. Verify from the perspective of computer system or computer system user.
黑盒测试：黑盒测试检查系统的功能，而不需要查看它的内部结构或工作原理。
Black box test: black box test checks the function of the system without checking its internal structure or working principle.
基本系统：无校准功能，框架或分层软件。如计算器、显微镜、微波炉、Windows系统、网络软件、数据库软件；这类系统不需要验证；
Basic system: no calibration function, framework or layered software. Such as calculator, microscope, microwave oven, Windows system, network software, database software; Such systems do not require verification;
简单软件：部分软件，限制定制。如：酸碱计，恒温器，热湿表/湿度计紫外线/vis光谱仪等。这类系统进行简单的验证，如控制功能、校验。
Simple software: partial software, limited customization. For example: pH meter, thermostat, hygrometer/hygrometer UV/vis spectrometer, etc. This kind of system is subject to simple verification, such as control function and verification.
复杂系统：带扩展功能的软件。如：LIMS,ERP,自动样品处理系统、液相色谱仪(LC,高效液相色谱法),气相色谱仪(GC)等。这类系统需要根据其功能进行验证。
Complex system: software with extended functions. Such as: LIMS, ERP, automatic sample processing system, liquid chromatography (LC, high performance liquid chromatography), gas chromatography (GC), etc. Such systems need to be verified according to their functions.
1.计算机化系统的一般要求：
1. General requirements for computerized system:
a)清单：应提供所有计算机化系统的清单，清单内容包括：
a) List: A list of all computerized systems shall be provided, including:
名称&版本
Name&Version
使用目的或用途
Purpose or purpose of use
验证状态
Verification status
计算机化系统和相关文件的存储位置或地址
Storage location or address of computerized system and related documents
b)验证：
b) Verification:
在使用之前，计算机化的系统应被验证，目的是为了确认计算机化的系统规范符合用户的需要和意图。验证的程度取决于被验证的计算机化系统的复杂性和预期用途。
Before use, the computerized system should be verified to confirm that the computerized system specifications meet the needs and intentions of users. The degree of verification depends on the complexity and intended use of the verified computerized system.
由供应商提供的验证：由软件供应商执行的验证文件和测试结果可以合并到验证文件中，不需要再次重复。供应商必须接受供应商评估。
Verification provided by the supplier: The verification documents and test results performed by the software supplier can be merged into the verification documents without repeating. The supplier must accept the supplier evaluation.
验证计划：为验证正常规范实施所指定的计划，应包括所有验证需执行的活动。
Verification plan: the plan specified to verify the normal specification implementation, which shall include all activities to be performed for verification.
c)日志：
c) Log:
d)变更控制：
d) Change control:
e)定期检查：
e) Regular inspection:
f)安全和环境：
f) Safety and environment:
g)审计追踪：
g) Audit trail:
h)电子签名：
h) Electronic signature:
i)备份：
i) Backup:
j)计算机化系统版本升级记录及备份：
j) Computerized system version upgrade record and backup:
k)培训：
k) Training:
l)文件：
l) File:
ANNEX 1复杂计算机化系统验证
ANNEX 1 complex computerized system verification
附件1主要是借助excel的验证，介绍了excel的流程
Annex 1 mainly introduces the process of excel through the validation of excel
ANNEX 2复杂计算机化系统验证
ANNEX 2 complex computerized system verification
2.用户需求
2. User requirements
对新软件的选择和购买，应基于对计算机系统的预期使用的要求。用户需求规范(用户需求规范)应该描述计算机系统的功能和技术需求，基本可以包括如下要求：
The selection and purchase of new software should be based on the requirements for the expected use of the computer system. The User Requirements Specification (User Requirements Specification) should describe the functional and technical requirements of the computer system, which can basically include the following requirements:
a)使用的软件的描述，包括版本;
a) Description of software used, including version;
b)对硬件部件和操作系统的要求;
b) Requirements for hardware components and operating system;
c)功能描述;
c) Function description;
d)对数据属性的描述;
d) Description of data attributes;
e)术语;
e) Terminology;
f)数据库设计，包括字段和数据类型，以及数据关系结构图。
f) Database design, including fields and data types, and data relationship structure diagram.
g)宏、公式和控制命令的要求;
g) Requirements for macros, formulas and control commands;
h)数据输入的要求(例如：格式、小数点、单位);
h) Requirements for data input (such as format, decimal point and unit);
i)对数据的强制性字段的说明;
i) Description of mandatory fields of data;
j)字段保护、工作表格及应用程序的描述;
j) Description of field protection, worksheet and application;
k)数据迁移的规划，如果适用;
k) Planning of data migration, if applicable;
l)数据录入、修改的审计追踪。
l) Audit trail of data entry and modification.
3.安装确认
3. Installation confirmation
计算机化系统安装后，应当进行文件化的测试。详细的安装程序应该由经培训的人员来进行。且应具有预定义安装步骤和验收标准的文件，确保系统的正确安装和安装的可追溯性。
After the computerized system is installed, a documented test shall be conducted. Detailed installation procedures should be carried out by trained personnel. It shall also have the documents of pre-defined installation steps and acceptance standards to ensure the correct installation and installation traceability of the system.
在大多数情况下，计算机系统被连接到一个计算机网络，并与其他软件(其他应用程序)和硬件(计算机设备或实验室设备)连接。必须确保系统正确地集成，并且所有的组件都是有效的。
In most cases, the computer system is connected to a computer network and connected to other software (other applications) and hardware (computer equipment or laboratory equipment). It is necessary to ensure that the system is properly integrated and that all components are effective.
安装确认通常包括：
Installation confirmation usually includes:
A)对硬件(服务器和客户端)的系统资源(存储空间、版本、型号等)的检查。
A) Check the system resources (storage space, version, model, etc.) of hardware (server and client).
b)关于系统组件的文件;
b) Documents about system components;
c)用户权限测试;
c) User permission test;
d)集成及通讯测试。
d) Integration and communication test.
4.运行确认
4. Operation confirmation
通过关键功能的测试检查软件的运行情况，理想情况下，可以使用右供应商提供的原始数据集来确定运行结果，然后与预期值进行比较。
Check the operation of the software through the test of key functions. Ideally, you can use the original data set provided by the right supplier to determine the operation results, and then compare them with the expected values.
如果没有这样的数据集，可以通过运行典型的示例来获取原始数据集。处理的原始数据集的结果应该通过使用标准(例如，电子表格)软件重新计算关键参数验证。
If there is no such data set, you can obtain the original data set by running a typical example. The results of the original data set processed should be verified by recalculating key parameters using standard (e.g. spreadsheet) software.
在安装了新的软件模块、新的软件版本、新的服务包、补丁更新或计算机软件结构的重大改变之后(如新的反病毒软件)之后，应该在基于风险的方法中进行运行确认。
After installing a new software module, a new software version, a new service package, a patch update or a major change in the computer software structure (such as a new anti-virus software), the operation confirmation should be carried out in a risk-based method.
5.性能确认
5. Performance confirmation
性能确认的目的是为了证明一个计算机化的系统适合于其在用户自己的环境中所定义的目标。用户需求应该在PQ阶段测试，以覆盖系统在日常工作中的总体业务使用。
The purpose of performance qualification is to prove that a computerized system is suitable for its defined objectives in the user's own environment. User requirements should be tested in the PQ phase to cover the overall business use of the system in daily work.
PQ通常包括:
PQ usually includes:
a)功能的测试(例如，使用一个数据集来确保应用程序的每个特征都被测试);
a) Functional testing (for example, using a data set to ensure that every feature of the application is tested);
b)挑战性测试;
b) Challenging test;
c)报警测试;
c) Alarm test;
d)未经授权的数据输入测试;
d) Unauthorized data input test;
e)异常数据的测试(例如，数据输入错误的数据格式);
e) Test of abnormal data (for example, data format with incorrect data input);
f)备份系统和恢复测试;
f) Backup system and recovery test;
g)数据迁移的验证，如适用;
g) Verification of data migration, if applicable;
h)符合数据保护要求的测试;
h) Testing in compliance with data protection requirements;
i)整个系统的验收测试黑盒测试。
i) Black box test for acceptance test of the whole system.