计算机系统验证方案中英.docx

1、计算机系统验证方案中英Computerised System Validation计算机系统验证质量保证部QADept.部门： Date/日Effective DateMonth/月Year/年生效日期： Confidential Level机密等级： Top-secret 绝密 Confidential 机密 Cryptical 秘密 Distribution List:分发清单：QA部、QC部、OSP固体制剂部、Lo.物控部、EN工程部、TD技术部、EQ设备部Role 责任人Draft 起草人Review 审核人Review 审核人Review 审核人Review 审核人Review 审核

2、人Review 审核人Approve 批准人Dept. 部门QAQCOSPLo. ENTDEQQDName姓名Signature签名Date日期1Objective 目的Test and assessment should be taken for URS, design, purchase, installation, function, as well as process adaptability of computerized and PLC control system related to GMP in compliance with this SOP so as to ensur

3、e that computerized and PLC are fit for design requirement and stated technical criteria and are able to work stably for a long time.根据本SOP，对URS、设计、采购、安装、功能以及GMP相关的计算机控制和PLC控制系统进行测试评估，以确保计算机和PLC符合设计要求和工艺要求并且能够长时间稳定工作。2Scope范围This SOP is fit for the validation management of computerized and PLC contr

4、ol system related to GMP, which apply to material control and management, laboratory equipment control and communication management, manufacturing process control, and utilities control. 本SOP适用于GMP相关计算机,PLC控制系统的验证管理，物料控制和管理,实验设备控制和通信管理、生产过程控制、公用设施的控制的验证。3Responsibilities 职责QA is responsible for draf

5、ting, revising, reviewing, training, implementing and supervising this SOP.QA负责起草、修订、审核、培训、实施和监督本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。相关部门负责审核和实施本SOP。4Definitions定义Computerized or PLC

6、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.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 la

7、nguage) 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),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。5Procedures 程序5.15.1.15.1.2Organization of Validation team and responsibility验证机构及责任Validation team

8、is composed of supplier, QA, Equipment Department, use department.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 protoc

9、ol, completing final report and participating validation deviation investigation and alteration review. 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, installi

10、ng system and implementing IQ, guiding use department on IQ and OQ process and participating validation deviation investigation and alteration 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

11、 validation protocol, participating validation deviation investigation and alteration approval and archiving validation 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。5.2System classification系统分级5.2.1Before validation, evaluation and classification should be carried out

12、 for system so as to insure that different grade validation should be provided for different type computerized and PLC control system. Classification as follows:在验证之前,评估和分级应当进行系统分类,以确保不同等级验证需提供不同类型的计算机化的,PLC控制系统,分类如下:Classification分类Description描述Validation method验证方法Operating system, network网络操作系统,E

13、stablished network and operating system for commerce. E.g. DOSWindows 95/98NT.已做好网络和操作系统例如:DOS Windows 95/98NT.Validate name and edition number确认名称及版本号Standard device, microcontroller, sensitive equipment标准配置,微控制器,灵敏的电气设备These system is designed by non-consumer for driving firmware which can be inst

14、alled in special integrate circuit (IC) for application, read only memory (ROM), random access memory (RAM), PLC sometimes, such as bar code modem, single-cycle controller, filling device, Checkweigher, temperature controller etc.这些系统是根据用户可以安装在特殊的集成电路(IC)的驱动固件,只读存储器(ROM)、随机存取存储器(RAM)、PLC,例如条形码调制解调器,

15、single-cycle控制器、灌装设备,重量控制、温度控制器等来设计的。Validate construction and configuration确认构造及配置Standard package标准程序包Ready-made package for commerce, such as multiplan software, standard chemical analysis software etc.现成的软件包,例如多计划软件,标准化学分析软件等。Validate application process验证应用过程Configurable package可配置的程序包Users develop their own application throughpre-definite software modules and developing application modules can be carried out in this