精心整理Computerised System Validation计算机系统验证Dept.部门：Effective Date生效日期：2This SOP is fit for the validation management of computerized and PLCcontrol system related to GMP, which apply to material control andmanagement, laboratory equipment control and communicationmanagement, 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, reviewing, training, implementingand 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 implementingthis SOP。
相关部门负责审核和实施本SOP。
4,55.1OQ 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 usedepartment to prepare URS and validation protocol, receivingsystem, installing system and implementing IQ, guiding usedepartment on IQ and OQ process and participating validationdeviation 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 validation deviationinvestigation and alteration approval and archiving validation protocoland 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。
5.2 System classification系统分级5.2.1 Before validation, evaluation and classification should be carried out for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。
5.3 Validation implementation验证实施5.3.1 URSURS should be prepared by system user and project expert detailed with fundamental requirement, expectation and performance index of new/changed computerized and 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 andinteraction between different module, control methods (e.g. logic control, 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2 3 chart,4 of and5 onand 6 5.3.2 System design系统设计5.3.2.1 System 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 chart 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. 2 Hardware design: include all I/O (input/output) 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、辅助动力装置,电子部件/电线/电缆、其他元件等。
5.3.2. 3 Software: include system software, application, and data. 软件:包括系统软件、应用和数据。
1spare,、2for3as protection, temperature, humility, sound, lighting, etc.系统安装环境的检验和记录:例如洁净水平、射频/电磁干扰、物理保护、温度、湿度、声音、照明等。
(2)Record condition of critical utilities and qualify that critical nature ofutilities should be fit for instruction including fire alarmannouncement/prevention, cooling system, electric power and itsadjustment, continuous power supply, wide area network connection,local area network connection, disaster recovery, telephone figure/analog, etc.记录关键设施以及条件, 鉴定的公共设施应该跟说明一致:包括消防报警公告/预防系统、冷却系统、电力及调整,持续供电、大面积网络连接,本地区域网络连接,灾难恢复、电话图形/模拟等(3)Qualify that record system is fit for requirement of man-machineengineer.条件和记录系统符合人控机工程师的要求。
5.3.3. 4 System test and qualification系统测试、条件(1) T he first step to do is to qualify that report items of FAT (factoryacceptance test) should be completely supplied by supplier and fit for design criteria.andon OQ的目的是进行所有功能运行情况方面的测试以确保系统和运行符合设计标准，内容如下：5.3.4.1Test for system security: “worst case”of all logic systems should be tested, e.g. use authority of different persons should be tested so as to identify that operation unauthorized should be forbidden.测试系统安全:“最坏情况”的系统逻辑应该进行测试,如使用不同权限以便确认未经授权运行是否被禁止。