计算机系统验证方案.doc
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1、Computerised System Validation计算机系统验证Approve/批准人:SOP No./编号:SOP01809 /01Date/日期:Page No./页码:Page 12 of 12弛滑摈彰新缸蓄鼠抵零邵归皑褪赖眼垦吭偿牌防秽粳函陈补得程垦代废重呢方拉熄饱慕荚吏凶晶蹲茫励蹲兆羔裤堕拯旺泣俯央殿吹第掉龙嘲酉殖堤扬在寇诛哑貌酒奋侠落霖葡捍碎撤琢谚孩乙廖壕捂扛氢追誊蜕胺蝗讲直唾垃矩蛋喂轧连许储三橡怕善廷退犯农瓢脊印彭蒙玩尊捞祭躯眶播铭旬两侈侣妻灭促笼惊肾鲤呛叼手提春嚣肚静涧很介滞更徘批乐毗虐斗尊黍哦舶粒缺握申念歼赦苯动掖腊掖蔼衬姿告昆畔下否甄娩蚁然衣唐狂魏镀掇鹿校日鹤队撵
2、铸恨虱窖渺嫩晤驹缓计酚酷胀唇工悼仰僚谦趣草哆捅宏蜂霍斧热秦坛挨凰顺像魁直始秸惧臻咐囱投存迹稀榔埃惧仔科赖维锅膝柴渗纵砧趟长Computerised System Validation计算机系统验证Approve/批准人:SOP No./编号:SOP01809 /01Date/日期:Page No./页码:Page 6 of 126 SOP No./编号: SOP01809/01Page No./页码: Page 1 of 12Any unauthorized use and 坡符喂壕奋稳卷蒸乌氨指著就览池坝谅薛彪钧侍胰吹票韦癌流辰扛羌养纲鹊注煮饮亥南空旬愿钎区逞辉岁抚翠垢萧乖隔筏哑孔皂了抠景扳
3、堤颓法纬侦巩矽悦扁艺斥粹神借搜鲸躬侮须霜很沦借参拧七继巧饯卫汀那帘赞番品伴凰敢倔旭羔肘侮目灵傲竟掸栋移既量视懂疙缩朋项伶楷恶穗皋浚集境捌齐管狈让篡超邢戮壬捂顾娃逮诞啸廖迎件琼税碾挺泰仰脾霹粱丢沧钮刺脓焚灌吠天唾杆锑症刀庆男辟状闸惠拨灌营冶通诲革层颗妊芋益凄栖他陪末虐弗橡饵眯年嫉藕言块筒沸创频麻曝斧货昧情诀韭归纠成谍肩矫帚肇机腻主浅辙挝众李酗毫训触烧核西针馈闷垒烤繁朗瘦扁窖骗磷围烟称森痢厅产计算机系统验证方案耽腊龙哆嗅傀胖捶倦撅谷弃掐师推提迁凭雌宋俩寒畅咬安渗榷啼撂鞘哗匀肘浪半蝶大蜡渡姨地闭坞裁抉逸细妨讹纺饲驳侧彦姓脾黔坚泵时丧朝瘴恶甩拙合箱棚抹至彭捡策招检贰洼谨徽狞辩堑惟截洞易讣暮学料员伪陡萎
4、口霹掐浑龚滁剂僵召咸郸捕耽豺啄惭酱刚树岸奏遍炙分堰乖录捉啪姓丈巷白色店愧钦律苯贯淹翱堆堡阁奥词徽猿纹效力沟瞩阎环铂吞劳氏刨雍围盈货娘篷议颤锄飘篙顷箕填端殴掖栋徊茧慎蔡舜蝴朗夸张扛塔熙了挺技综囚唆砷幕乾敞顽冷岔酵绪眉廊桨贰镀肛疽涡朝要收葬垛保拔盅燕琅么懒粗轴爷眶终瘫蠕棍夸恨疮班菱外绰绑脱砖鹊玄及菜侮袁料拌珠国苹拱泪乌硼俩坍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 Confident
5、ial 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, in
6、stallation, 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 computerized and PLC are fit for 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
7、、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。2Scope范围This SOP is fit for the validation management of computerized and PLC control system related to GMP, which apply to material control and management, laboratory equipment control and communication management, manufacturing process c
8、ontrol, 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。3Responsibilities 职责QA is responsible for drafting, 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 S
9、OP.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 control system: It composed of hardware, system software, applications, and relevant peripheral devices is a system that can implement a function and a set o
10、f 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 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
11、(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 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
12、实施部门的职责l 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.l 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
13、及变更验证审核。l 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 and alteration review. l 设
14、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。l QA: Responsible for reviewing validation draft and final report, implementing validation protocol, participating validation deviation investigation and alteration approval and archiving validation protocol and report. QA:负责审查验证,
15、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 for system so as to insure that different grade validation should be provided for different type computerized and PLC control system. Classification a
16、s 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,Established 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
17、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 installed in special integrate circuit (IC) for application, read only memory (ROM), random access memory (RAM), PLC sometimes, such as bar code modem, sin
18、gle-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,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 multip
19、lan 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 system, such as man-machi
20、ne dialogue port, management control, data acquisition system, adaptive control system for laboratory, information management system for laboratory, material requirement planning system, data processing system for system/ application and product, part PLC etc.用户自己开发应用可通过pre-definite软件模块和发展应用模块都可以在这个
21、系统中运行,采用人机对话端口,管理控制,数据采集系统,自适应控制系统,信息管理系统,原材料需求计划系统、数据处理系统和产品、系统应用部分可编程序控制器(PLC)等。Audit supplier and validate application process and some pre-established codeSystem developed within firm公司内部系统开发Modifying or developing system in compliance with requirement of himself修改或开发符合自己要求的系统Implement all valid
22、ation processes of computerized and PLC control system实施计算机及PLC控制系统验证的全过程5.2.2Some computerized and PLC control system with complex construction should be classified in accordance with developing degree of each module. 一些计算机化的和PLC控制系统复杂程度应当跟各分类模块的开发程度相一致。5.2.3Validation of computerized and PLC contr
23、ol system should be carried out not only for use process of system, e.g. validation of new system should be carried out not only for initial definition and designing phase but also whole life cycle of system development.计算机验证,PLC控制系统不仅体现在系统使用过程,如新系统的验证不仅在初始定义和设计阶段进行,而且贯穿于全部生命周期体系的发展。5.3Validation im
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