文档介绍：SOP No./ 编号:
SOP01809/01
Page No./ 页码:
Page 1 of 12
Computerised System Validati on
计算机系统验证
Dept.
部门： QA / 质量保证re, system software, applicati ons, and releva nt peripheral devices is a system that can impleme nt a function and a set of fun cti ons.
无论是计算机化还是PLC控制系统:都是由硬件、系统软件、应用、及相关的周边设备组成的一个系统，可以实现某一功能和一套功能。
Source code: It is source program of computer whose format( program Ian guage) can be read by operator, before computer executi on, it should be tran slate to mach ine Ian guage whose format can be executed by computer.
源代码:它是计算机的源程序(程序语言),可以在电脑执行前被计算机识别，它应该被翻译成可以被计算机识别的机器语言。
Procedures 程序
5 1 Orga ni zati on of Validati on team and resp on sibility
' 验证机构及责任
Validati on team is composed of supplier, QA, Equipme nt Departme nt, use departme nt.
验证团队由供应商,QA、工程设备部和使用部门组成。
Implementation department responsibility of system validation 系统验证实施部门的职责
Use department: Responsible for providing written URS, preparing validation protocol and report, implementing approved IQ and OQ protocol, completing final report and participating validation deviation investigation and alteration review.
Computerised System Validati on
Approve/批准人：
SOP No./ 编号：SOP01809 /01
计算机系统验证
Date/日期：
Page No./ 页码：Page 3 of 12
使用部门：负责提供书面的URS,准备验证方案和报告、实施批准IQ,OQ协议，完成最终报告偏差并参与调查及变更验证审核。
Equipment Department: Responsible for cooperating with use department to prepare URS and validation protocol, receiving system, installing system and implementing IQ, guiding use department on IQ and OQ process and participati ng validati on deviati on inv estigati on and alterati on review.
设备部门：负责准备使用部门的合作协议，并确认你接收系统，安装系统，实施IQ,指导使用部门关于IQ和OQ的验证过程和参与验证偏差调查和变更回顾。
QA: Responsible for reviewing validation draft and final report, implementing validation protocol, participating validation deviation investigation and alteration approval and archi ving validati on protocol and report.
QA:负责审查验证,也是最后一项报告草案、实施验证方案，参与调查及变更验证偏差的批准验证方案和归档，并做好报告。
System classificati on
系统分级
Before val