计算机系统验证方案.docx

1、计算机系统验证方案Computerised System Validation计算机系统验证Dept.部门：Effective Date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 审核人Review 审核人Approve 批准人Dept.

2、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 ensure that computerized and PLC

3、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、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 ap

4、ply 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。3Responsibilities 职责QA is responsible for drafting, revising, reviewing, training

5、, 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 control system: It composed of hard

6、ware, 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 be read by operator, be

7、fore 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 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 par

9、ticipating 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, guid

10、ing 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

11、 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 for system so as to insure that di

12、fferent 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,Established network and operating sy

13、stem 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 installed in special integrate circuit

14、(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,single-cycle控制器、灌装设备,重量控制、温度控制器等来设计

15、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 throughp

16、re-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 system for laboratory, material requirement planning syste

17、m, 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 f

18、irm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 validation 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

19、 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 control 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 who

20、le 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 implementation验证实施5.3.1URSURS should be prepared by system user and project expert detailed with fundamental requirement, expectation and performance index of new/changed computerized an

21、d PLC control system, which will be use to determine system designing criteria. Content as follow:URS应该为系统用户和项目专家准备基本要求详细的,预期和新的性能指标、更改计算机化和PLC控制系统,可以用来决定系统设计标准。内容如下:System description: what to do about system, how connection and interaction between different module, control methods (e.g. logic cont

22、rol, separation control, interlock control, alarm control, location control, temperature control, pressure control, time control, counting and other multipolar control), implementing process, ports and safety requirement for operator.系统描述:系统做到什么程度,如何关联不同模块、控制方法(例如:逻辑控制、分离控制,连锁控制、报警控制、位置控制,温度控制,压力控制、

23、时间控制、计数和其他多级控制)、实施流程、操作员的端口和安全标准。5.3.1.2Physical requirement: include sufficient space, location, peripheral environment, etc.物理要求:包括有足够的空间,位置,周边环境等。5.3.1.3Document criteria for hardware: include chart paper, schematic chart, hand book, spare parts list etc.硬件的文件标准:包括:图纸,原理图,操作指南,备件清单等。5.3.1.4Docume

24、nt criteria for software: include program number and revising number, output program and detailed explanation, reproduction of software provision and retention condition, system block drawing and configuration list. 软件的文件标准:包括程序编号和修改编号,输出接口程序和详细说明、软件的追加和保留条件、系统分程序图纸和配置清单。5.3.1.5Test requirement: tes

25、t items and record required to be carried out on system developing process, including module separated test and integrated test.测试要求:测试项目和记录必须在系统的发展过程中进行,包括模块测试和集成分离测试。5.3.1.6 Other requirement to supplier: such as finished system validation, quality control and change control on developing process,

26、 etc. 对供应商的其他要求:如在发展进程中完成系统验证、质量控制和变更控制等。5.3.2System design系统设计5.3.2.1System design should compose of system configurable chart design, hardware design, and software design. After document of system design reviewed and approved by consumer which should be prepared by supplier, system configurable ch

27、art design should be carried out, including system PID (process and instrument), I/O (input/output) connection diagram, control element pareto diagram.系统设计应该由系统配置图、硬件设计和软件设计组成。在供应商准备的系统设计被用户评估和检验后，可配置的系统图纸设计应该完成,包括系统PID, I/O (输入/输出)连接图、连接原理帕累托图。5.3.2.2Hardware design: include all I/O (input/output)

28、connection template and type, CPU selection, communication template, man-machine Interface controller, screen viewer selection, medium relay, memory, printer, auxiliary power unit, electronic element/wire/cable, other elements etc.硬件设计:包括所有I/O (输入/输出)连接模板和类型,CPU选型,通信模板、人机界面控制器,屏幕查看选择、中继电器、记忆存储器、打印机、

29、辅助动力装置,电子部件/电线/电缆、其他元件等。5.3.2.3Software: include system software, application, and data.软件:包括系统软件、应用和数据。5.3.3IQIQ should be carried out to ensure that system installation is fit for design criteria and needed technical data should be completely provided. Special content as follow:IQ应该确保该系统安装符合设计标准和工

30、艺需求，数据完全提供。特殊内容如下:5.3.3.1Document qualification should consist of consumer technical guide, SOP, training plan, post-sale service agreement, equipment inventory, security program, hardware qualification, software qualification, source code, instrument list, instrument calibration procedure, PID, con

31、trol loop diagram, I/O (input/output) device list and connection diagram, spare parts list, and maintenance procedure. 文件确认应该由用户工艺要求、SOP,培训计划,售后服务协议、设备库存,安全程序、硬件说明,软件说明,源代码、仪器清单、仪器校准程序、PID、控制回路图,I/O(输入/输出设备清单和连接图,备件清单和维护规程。5.3.3.2Installation process qualification: qualify that installation is fit for requirement PID and operating manual.安装过程说明:安装符合PID和操作手册的要求。5.3.3.3Circumstance and utilities qualification事件和实用程序说明(1) Qualify and record circumstance of system installation, such as clean leve