文档介绍：计算机系统考证方案
计算机系统考证方案
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计算机系统考证方案
Computerised System Validation
计算机系统考证
Dept.
部门：
草、修订、审核、培训、实施和监察本 SOP。
The quality director is responsible for approving this SOP.
质量副总负责批准本 SOP。
Relevant departments are responsible for reviewing and implementing this
SOP。
有关部门负责审核和实施本 SOP。
Definitions 定义
Computerized or PLC control system: It composed of hardware, system
software, applications, and relevant peripheral devices is a system that
can implement a function and a set of functions.
计算机系统考证方案
计算机系统考证方案
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计算机系统考证方案
不论是计算机化仍是 PLC控制系统 : 都是由硬件、系统软件、应用、及有关的周边设备
组成的一个系统 , 能够实现某一功能和一套功能。
Source code: It is source program of computer whose format( program language) can be read by operator, before computer execution, it should be translate to machine language whose format can be executed by computer.
源代码 : 它是计算机的源程序 ( 程序语言 ), 能够在电脑履行前被计算机辨别 , 它应当被翻
译成能够被计算机识其他机器语言。
5 Procedures 程序
Organization of Validation team and responsibility
考证机构及责任
Validation team is composed of supplier, QA, Equipment Department, use
department.
考证团队由供给商 ,QA、工程设备部和使用部门组成。
Implementation department responsibility of system validation
系统考证实施部门的职责
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.
计算机系统考证方案
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计算机系统考证方案
使用部门 : 负责提供书面的 URS,准备考证方案和报告、实施批准 IQ,OQ 协议 , 达成
最终报告偏差并参与检查及更改考证审核。
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
participating
validation
deviation
investigation