正文
- Function control test
功能控制测试
Extended amount of Functionality software
扩展功能软件
Extendedcustomisation
高度定制化
LIMS (Laboratory Information Management System), ERP (Enterprise Resource Planning), eDMS (electronic Document Management System), ELN (Electronic Laboratory Notebooks), user-developed Excel spreadsheet, user-developed Access application, automated sample processing systems, liquid chromatograph (LC, HPLC), gas chromatograph (GC) including auto sampler and detection systems (UV, VIS, IR, MS, NMR, radioactivity or fluorescence monitor, etc.), biological analyser, ECG, etc.
LIMS
（实验室信息管理系统）、
ERP
（企业资源规划系统）、
eDMS
（电子文件管理系统）、
ELN
（实验室电子笔记本）、用户自行开发的
Excel
电子表格、用户自行开发的访问应用程序、自动样品处理系统、液相色谱（
LC
、
HPLC
）、气相色谱，包括自动进样检测系统（
UV, VIS, IR, MS, NMR,
放射性或荧光监测等）、生物分析仪、
ECG
等
Validation
验证
Complex
复杂的
部分翻译如下：
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时，应与其一起使用。EXCEL电子表格的验证见附录一，本文不适用。
2. USER REQUIREMENTS SPECIFICATIONS (URS)
用户需求规范（URS）
