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1、Computerised System Validation计算机系统验证Dept.部门:Effective DateMonth/ 月生效日期： Year/Confidential Level机密等级： Top-secret 绝密 Confidential 机密 Cryptical 秘密QA /质量保证部Distribution List?:分发清单：Dt/QA部、QC部、OSP固体制剂部、Lo.物控部、EN 工程tR日11技术部、EQ设备部日1 Objective 目的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
2、审核人Review 审核人Approve 批准人Dept.部门QAQCOSPLo.ENTDEQQDName姓名Signature 签名Date日期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 ensure that compu
3、terized and PLC are fitfor design requirement and stated technical criteria and are able to work stably for a long time.测试、评估采取的URS、设计、采购、安装、功能以及计算机控制和PLC 控制系统符合GMP，以确保计算机和PLC符合设计要求和工艺要求并且能 够稳定工作很长时间。2 Scope范围This SOP is fit for the validation management of computerized and PLC control system relate
4、d to GMP, which apply to material control and management, laboratory equipment control and communication management, manufacturing process control, and utilities control.本SOP适用于电脑,PLC控制系统的管理是否符合GMP,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。3 Responsibilities 职责QA is responsible for drafting, revising,
5、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。4 Definitions 定义Computerized or PLC control syste
6、m: 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 language) can
7、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 另U,它应该被翻译成可以被计算机识别的机器语言。5 Procedures 程序of Validation team and responsibility验证机构及责任Validation team is composed of supplier, QA, Equipm
8、ent 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 protocol, completing final report and part
9、icipating 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, installing system and implementing IQ, guidin
10、g 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 validation protocol, participating v
11、alidation 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。System classification 系统分级validation, evaluation and classification should be carried out for system so as to insure that different grade va
12、lidation 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：Validationmethod验证方法Description描述Classification分类Operating system, network 网络操作系 统，Established network and operating system for comme
13、rce. . 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, microcontrol ler, sensitive equipment 标准配置，微 控制器，灵敏 的电气设备These system is designed by nonconsumer for driving firmware which can be installed in special integrate circuit (IC) for app
14、lication, read only memory (ROM), random access memory (RAM), PLC sometimes, such as barcodemodem,single-cyclecontroller,fillingdevice,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,single-cycle控制器、 灌装设备，重量控制、温度控制器等来设计 的。Validate con
15、structi on and configurat ion 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 applicatio n process 验证应用过 程Configurable package 可配置的程序 包Users develop their own application through pre-definite software modules and developing application modules can be carried out in this system, such as man-machine dialogue port, management control, data acquisition system, adaptive control system for laboratory, information management
