计算机系统验证omcl,201803复杂计算机化系统的验证omcl指南附录2.docx

201803 复杂计算机化系统的验证 omcl 指南附录 2

重要的话只说一遍： 本附录为 OMCL 指南“计算机化系 统验证”的附录，并非 EU GMP 附录“计算机化系统验证 “的 附录！！ PA/PH/OMCL(08) 88 R5 计算机化系统的验证一附 录2 复杂计算机化系统的验证生效日期： 2018-08-01 ANNEX 2 OF THE OMCL NETWORK GUIDELINE “VALIDATION OF COMPUTERISED SYSTEMS” “计算机化系统的验证”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：本指南及其附录中的强制要求采用术语“应” 或“必须”

进行定义。使用“应”表示是建议，其下所列要求可采用经 过适当论证的其它方法来实施。 术语“可”表示一种可能性， 或非强制特性举例。

INTRODUCTION 前言

This is the 2nd Annex of the core d ocument “ 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. 本文是“计算机化系统的验证”核心文件的附录2，在规划、

实施和记录复杂计算机化系统的验证步骤中应与该核心文 件联合使用。 EXCEL 表格的验证在核心文件附录 1 中进行 了描述，不包括在此文中。

USER REQUIREMENTS SPECIFICATIONS (URS) 用 户需求手册( 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. 新软件及相关计算机和化验室设备的选择和采购应遵照基 于计算机化系统既定用途需求的简洁决策流程。 应按 OMCL

定义，在用户需求手册( URS )中描述计算机化系统里软件 和硬件的功能性和技术性需求。 URS 还应覆盖安全信息和数 据完整性方面要求。

Some of the items that can be included are: 可以包括的项目有：

Description of the software used (e.g. Excel, Access,

Oracle), including version;

所用软件的描述(例如， EXCEL