OMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT

质量保证文件 PA/PH/OMCL (08) 89 R

VALIDATION OF COMPUTERISED SYSTEMS

计算机化系统验证

ANNEX 3: VALIDATION OF COMPUTERS AS PART OF TEST

EQUIPMENT

附件3：检测设备所用计算机的验证

Full document title and reference 文件全名及索引号 Validation of Computerised Systems Annex 3: Validation of computers as part of test equipment PA/PH/OMCL (08) 89 R Document type 文件类型 Legislative basis 立法基础 Date of first adoption 首次采用时间 Date of original entry into force 首次生效时间 文件生效时间 Previous titles/other references 曾用文件名/其它- 参考文件 Custodian Organisation 管理机构 Concerned Network 相关网络 The present document was elaborated by the OMCL Network/EDQM of the Council of Europe GEON Guideline 指南 - May 2009 July 2009 Date of entry into force of revised document修订- ANNEX 3 OF THE OMCL NETWORK GUIDELINE “VALIDATION OF COMPUTERISED SYSTEMS”

附件3 计算机系统的验证

VALIDATION OF COMPUTERS AS PART OF TEST EQUIPMENT

检验设备所用计算机的验证

INTRODUCTION 概述

The present document is the 3rd Annex of the core document “Validation of Computerised Systems”, and it should be used in combination with it when planning, performing and documenting the validation steps of computerised systems. 本文件是主文件“计算机系统验证”的附录3，在计划、实施和记录计算机系统验证时应将本文与该主文件联合应用。

The core document contains the Introduction, Scope and general requirements for the validation of different types of computerised systems. 主文件包括了不同各类计算机系统验证的概述、范围和通用要求。

This Annex contains additional recommendations, which are to be used in combination with the general recommendations given in the core document. It is addressed to software for controlling laboratory equipment and evaluation of

analytical raw data. 附录包括附加的推荐，其应该与主文件中的通用推荐一起使用。本附录应用于实验室设备控制用计算机软件系统和原始分析数据评价用计算机软件系统。

This document should be considered as a guide to OMCLs for planning,

performing and documenting the validation of their computerised systems. It should not be taken as a list of compulsory requirements. It is left to the professional

judgement and background experience of each OMCL to decide on the most relevant procedures to be undertaken in order to give evidence that their computerised systems are working properly and are appropriate for their intended use. 本文件是供OMCL计划、实施和记录计算机系统验理论上的一个指南，而不是一个强制要求的清单。各OMCL应根据自己的专业判断和背景经验来决定采取最佳程序，以证明其计算机系统能正常工作并适用于其指定用途。

Level I. Selection of Software and Computer Equipment 第一级 计算机设备和软件的选择

The selection and purchase of new software and the associated computer

equipment should follow a conscious decision process based on the requirements for the intended use of the test equipment. Usually the first step is the selection of software which meets the analytical requirements of the intended applications.

Typical requirements are listed in Table 1. In the second step, appropriate computer equipment is selected which meets all hardware requirements of the selected software. Typical requirements are listed in Table 2. 对（检验用）计算机新软件和相关的计算机设备的选择和采购应基于检测设备的使用目的要求。一般第一步是选择符合使用目的的分析要求的软件。典型的要求在表1中列出。第二步是选择计算机设备符合软件运行条件的所有硬件要求。典型的要求在表2中列出。

TABLE 1: ANALYTICAL REQUIREMENTS ON THE SOFTWARE 表一：软件方面的检测要求

— Integration algorithms (Peak detection, identification, evaluation parameters, etc) 积分算法 （峰检测、鉴别、参数评价等）

— Calibration algorithms 校正算法

— System suitability functions (Symmetry factor, theoretical plates, resolution, etc) 系统适用性功能（对称因子、理论塔板数、分辨率等）

— Statistical functions (mean, standard deviation, etc) 统计功能（平均值、标准偏差等）

— Control of the analytical system 分析系统控制

— User management, i.e. the administration of user accounts and the definition of user privileges. 用户管理，即用户帐户的管理和用户权限的定义

— Electronic signature 电子签名

— Compatibility to external software (LIMS, Excel, etc) 外部软件比较性（LIMS，Excel等）

TABLE 2: HARDWARE REQUIREMENTS 表二：硬件要求

— Hardware components 硬件元件 — Operating system 操作系统

— Interfaces. Particular attention should be paid to the characteristics of the a/d converters, which may have an impact on the resolution, the accuracy, the

linearity or the sampling rate. 界面：需要特别注意数模转换特性，这可能会对分辨率、准确度、线性或进样率有影响

For software and associated computer equipment already in use the user

requirement specifications may be described retrospectively. 对于已经在用的计算机设备和软件，用户需求手册可以进行回顾性描述。

Level II. Installation Qualification 第二级 安装确认

Once the software and the computer equipment are selected and purchased, the whole system should be installed and connected to the analytical instrument by appropriately trained personnel. After installation, the system should be adequately qualified. Typical parameters to be tested are listed in Table 3. 一旦选择和购买了计算机设备和软件，整套系统应由有接受过适当培训的人员安装和连接到分析设备上。安装完成后，系统应进行充分验证，需测试的典型参数在表三中列出。

TABLE 3: INSTALLATION QUALIFICATION 表三：安装确认

— Verification that the correct operating system (incl. version and service package) is installed. 确认操作系统正确安装（包括版本和服务包）

— Verification that the software controls the analytical instrument. 确认软件可以控制分析设备

— Verification that the measuring signal(s) is (are) transferred to the software. 确认测量信号转移至软件

— Verification of the correct function of the user management. 确认用户管理功能正确

Level III. Qualification of the software functionality 第三级 软件功能确认

The proper function of the software should be checked by testing the

performance of key functions like calibration and quantification (internal standards, external standards), peak identification, and calculation of system suitability

parameters. 应检查以下关键软件功能运行正常：校正和定量（内标、外标）、峰鉴别、系统适用参数计算）。

Ideally, a raw data set can be used for which the results are known. These raw data sets are often provided by the vendor of the software. These raw data sets are processed by the software and the results are then compared to the expected values. 理想情况下，可以使用一个已知结果的一系列原始检验数据进行验证。通常软件供应商会提供这种数据，将原始数据输入系统并进行运算，将所得结果与期望值进行比较。

If no such data sets are available, example raw data sets can be acquired by

running typical samples. The results of the processed raw data sets should be verified by recalculating the key parameters (e.g. calibration curves from peak areas of

standards) using standard spreadsheet software. 如果没有这类数据，可以分析典型样品来得到原始数据，计算结果与通过另一标准计算软件得到的结果进行比较（例如由标准的峰面积的校正曲线）。

Level III Qualification should be repeated after installation of new software modules, new software versions, new service packs, patch updates, or after major changes in the software structure of the computer (e.g. new Anti-virus software).

Analogous behaviour should be applied for every change in hardware platform. 在增加新模块、软件升级、增加功能、安装补丁或计算机软件结构进行重大变化（例如安装新的杀毒软件）后，第三级确认需要再次进行。每次硬件平台的变更应该进行模拟。

Level IV. Suitability for specific test procedures 第四级 特定检测方法的适用性

In connection with the validation of an analytical procedure, calculations performed by the software of the relevant computerised system should be checked. Special emphasis should be placed on grouping of data and statistical analysis of the results. In many new software programs it is possible to implement user-defined calculations and control fields. The proper function of these parameters has to be

checked by example calculations. These user-defined calculations should be locked or password protected to prevent overwriting. 对检验方法进行验证的时候，还要检查由相关计算机系统的软件进行的计算。特别需要强调的是数据的收集和结果的统计学分析。在有些软件程序中，允许用户自定义计算公式及锁定区域，这些自定义计算的参数需要用举例试计算来进行检查。这些用户自定义计算应该进行锁定或密码保护以防止误写。