2025年edqm计算机化系统验证,EDQM-复杂计算机化系统的验证-附录2-2018.pdf

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ANNEX 2 附录2

VALIDATION OF COMPLEX COMPUTERISED SYSTEMS

复杂计算机化系统的验证

Note: Mandatory requirements in this guideline and its annexes are defined using the terms «shall»

or «must». The use of «should» indicates a recommendation. For these parts of the text other

appropriately justified approaches are acceptable. The term «can» indicates a possibility or an

example with non-binding character.

注：本指南及其附录的强制要求明确使用 “shall ”或 “must ”。使用 “should ”表示建议。

对此，其他适当的合理方法也是可以接受的。使用 “can ”表示可能或不具约束力的举例。

1. INTRODUCTION 介绍

This is the 2nd Annex of the core document “Validation of Computerised Systems”, and it should

be used in combination with the latter when planning, performing and documenting the validation

steps of complex computerised systems Excel spreadsheet validation is described in the 1st Annex

of the core document and not subjected here.

此为核心文件《计算机化系统验证》的第二个附录，当计划、执行和记录复杂计算机化系统

验证步骤时，应与其一起使用。EXCEL 电子表格的验证见附录1，本文不适用。

2. USER REQUIREMENTS SPECIFICATIONS (URS) 用户需求规范(URS )

The selection and purchase of new software and the associated computer and laboratory equipment

should follow a conscious decision-making process based on the requirements for the intended use

of the computerised system. A User Requirements Specification (URS) should describe the

functional and technical requirements of the computerised system, as defined by the OMCL, in

terms of both software and hardware. It should also cover the aspects of information security and

data integrity.

新软件和相关计算机以及实验室设备的选择和购买应遵循基于计算机化系统的既定使用需

求的决策程序。用户需求规范(URS )应描述计算机化系统软件和硬件的功能和技术要求。

同时，应包括信息安全和数据完整性方面的要求。

Some of the items that can be included are:

包括以下一些信息：

a) Description of the software used (e.g. Excel, Access, Oracle), including version;

所用软件的描述(如EXCEL、Access 、Oracle )，包括版本

b) Requirements on hardware components and operating system;

硬件配件和操作系统的要求

c) Description of functio