计算机系统验证方案-中英

计算机系统验证 方案 气瓶 现场处置方案 .pdf气瓶 现场处置方案 .doc见习基地管理方案.doc关于群访事件的化解方案建筑工地扬尘治理专项方案下载 -中英 SOP No./编号: SOP01809/01 Page No./页码: Page 1 of 14 Computerised System Validation 计算机系统验证 Dept. 部门: QA 质量保证部 Effective Date 生效日期: Year/年 Month/月 Date/日 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 Draft Review Review Review Review Review Review Approve 责任 安全质量包保责任状安全管理目标责任状8安全事故责任追究制幼儿园安全责任状占有损害赔偿请求权 人 起草人 审核人 审核人 审核人 审核人 审核人 审核人 批准人 Dept. QA QC OSP Lo. EN TD EQ QD 部门 Name 姓名 Signature 签名 Date 日期 1 Objective 目的 Approve/批准人: SOP No./编号:SOP01809 /01 Computerised System Validation Date/日期: Page No./页码:Page 2 of 14 计算机系统验证 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 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。 Scope范围 2 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 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。 Responsibilities 职责 3 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 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。 Definitions定义 4 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 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, 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 阿房宫赋翻译下载德汉翻译pdf阿房宫赋翻译下载阿房宫赋翻译下载翻译理论.doc 成可以被计算机识别的机器语言。 Procedures 程序 5 Organization of Validation team and responsibility 5.1 验证机构及责任 Validation team is composed of supplier, QA, Equipment Department, use 5.1.1 department. 验证团队由供应商,QA、工程设备部和使用部门组成。 5.1.2 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 participating validation deviation investigation and alteration review. Approve/批准人: SOP No./编号:SOP01809 /01 Computerised System Validation Date/日期: Page No./页码:Page 3 of 14 计算机系统验证 , 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, 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 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。 System classification 5.2 系统分级 Before validation, evaluation and classification should be carried out for system so 5.2.1 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: Validation Classification Description method 分类 描述 验证方法 Validate Operating Established network and operating system for name and system, commerce. E.g. DOS\Windows 95/98NT. edition network 已做好网络和操作系统例如:DOS\ Windows number 网络操作系统, 95/98NT. 确认名称及版 本号 These system is designed by non-consumer for driving firmware which can be installed in special Standard integrate circuit (IC) for application, read only device, memory (ROM), random access memory (RAM), Validate microcontroller, PLC sometimes, such as bar code modem, construction sensitive single-cycle controller, filling device, and equipment Checkweigher, temperature controller etc. configuration 标准 excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载 配置,微控这些系统是根据用户可以安装在特殊的集成电路确认构造及配 制器,灵敏的电(IC)的驱动固件,只读存储器(ROM)、随机存取存储置 气设备 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。 Ready-made package for commerce, such as Validate Standard multiplan software, standard chemical analysis application package software etc. process 标准程序包 现成的软件包,例如多计划软件,标准化学分析软件验证应用过程 等。 Approve/批准人: SOP No./编号:SOP01809 /01 Computerised System Validation Date/日期: Page No./页码:Page 4 of 14 计算机系统验证 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, Audit supplier adaptive control system for laboratory, and validate information management system for laboratory, application Configurable material requirement planning system, data process and package processing system for system/ application and some pre-可配置的程序包 product, part PLC etc. established 用户自己开发应用可通过pre-definite软件模块和code 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。 Implement all validation processes of System computerized developed Modifying or developing system in compliance and PLC within firm with requirement of himself control 公司内部系统开修改或开发符合自己要求的系统 system 发 实施计算机及 PLC控制系 统验证的全过 程 Some computerized and PLC control system with complex construction should be 5.2.2 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。 Validation of computerized and PLC control system should be carried out not only for 5.2.3 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。 Validation implementation 5.3 验证实施 URS 5.3.1 URS 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、,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: Approve/批准人: SOP No./编号:SOP01809 /01 Computerised System Validation Date/日期: Page No./页码:Page 5 of 14 计算机系统验证 System description: what to do about system, how connection and interaction 5.3.1.1 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、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。 Physical requirement: include sufficient space, location, peripheral environment, etc. 5.3.1.2 物理要求:包括有足够的空间,位置,周边环境等。 Document criteria for hardware: include chart paper, schematic chart, hand book, 5.3.1.3 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。 Document criteria for software: include program number and revising number, output 5.3.1.4 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。 Test requirement: test items and record required to be carried out on system 5.3.1.5 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。 Other requirement to supplier: such as finished system validation, quality control 5.3.1.6 and change control on developing process, 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。 System design 5.3.2 系统设计 System design should compose of system configurable chart design, hardware 5.3.2.1 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。 Hardware design: include all I/O (input/output) connection template and type, CPU 5.3.2.2 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。 Software: include system software, application, and data. 5.3.2.3 软件:包括系统软件、应用和数据。 IQ 5.3..3 Approve/批准人: SOP No./编号:SOP01809 /01 Computerised System Validation Date/日期: Page No./页码:Page 6 of 14 计算机系统验证 IQ 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艺需求，数据完全提供。特殊内容如下: Document qualification should consist of consumer technical guide, SOP, training 5.3.3.1 plan, post-sale service agreement, equipment inventory, security program, hardware qualification, software qualification, source code, instrument list, instrument calibration procedure, PID, control 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。 Installation process qualification: qualify that installation is fit for requirement PID and 5.3.3.2 operating manual. 安装过程说明:安装符合PID和操作手册的要求。 Circumstance and utilities qualification 5.3.3.3 事件和实用程序说明 (1)Qualify and record circumstance of system installation, such as clean level, radiofrequency/electromagnetic interference, physical 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 of utilities should be fit for instruction including fire alarm announcement/prevention, cooling system, electric power and its adjustment, 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-machine engineer. 条件和记录系统符合人控机工程师的要求。 System test and qualification 5.3.3.4 系统测试、条件 (1) The first step to do is to qualify that report items of FAT (factory acceptance test) should be completely supplied by supplier and fit for design criteria. 第一步要做的是,报告项目FAT的验收测试应该完全由供应商提供,适用于设计标准。 (2) Necessary test should be carried out for system on operational circumstance. Essential content as follow: 应该对系统运行情况开展必要的测试。基本内容如下: , All instruments and meters should be calibrated and on expire day of calibration. Calibration should be fit for definite criteria and corresponding certification should 5.3.4 be provided. 所有仪器仪表应该被校准和标注过期日，校准应该有明确的标准及应提供相应的检查证件。 , I/O (input/output) signal test should be carried out so as to ensure that single can Approve/批准人: SOP No./编号:SOP01809 /01 Computerised System Validation Date/日期: Page No./页码:Page 7 of 14 计算机系统验证 transmit from control system to device and return. I/O (输入/输出)信号试验应确保信号可以在控制系统设备间进行传输和反馈。 , Data acquisition and transmission and signal memory test 数据采集,传送和信号记忆测试 , Other tests 其他测试 OQ (operation qualification) 运行确认 The purpose of OQ is that all function tests should be carried out on operational circumstance so as to ensure that system and operation should be fit for design criteria. Content as follow; 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: 5.3.4.1 Test 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。 5.3.4.2 Various processes control function tests required by system request: “ worst case “ ( e.g. maximum communication load, process of considerable data document, etc.) test for all function of system and decision routines should be carried out in accordance with various requirements and criteria supplied by system definition. (It is important that a functional diagram including all branch routines should be provided. ) 根据系统要求进行的各种各样的过程控制功能的测试:“最坏情况”(例如最大通信承载、过程相当大的数据文件等)试验检查系统和决策程序的功能,应根据系统不同的要求和标准提供的定义。(提供功能图表包括所有出现的偏差是非常重要的。) 5.3.4.3 Test for alarm and interlock: efficacy of corresponding program should be tested on the condition of alarm and interlock for system in accordance with system operation manual. 检测 工程第三方检测合同工程防雷检测合同植筋拉拔检测方案传感器技术课后答案检测机构通用要求培训 报警及连锁:程序连锁应根据报警条件及系统连锁操作手册进行测试。 5.3.4.4 Test for timer and sequencer: establish time and program of system generating corresponding function according to system operation manual so as to validate efficacy of system timing or ordering program. 定时器和定序器测试: 根据系统的操作手册设置时间和系统产生相应的功能以确认系统有效时间或程序命令 Approve/批准人: SOP No./编号:SOP01809 /01 Computerised System Validation Date/日期: Page No./页码:Page 8 of 14 计算机系统验证 5.3.4.5 Test for data disposal and memory 测试数据处理和记忆 (1) Qualify correct data memory, collection and search of system’s own. 正确的数据记忆,准确的数据采集和系统的自我搜索的确认。 (2) Qualify disposal of data output length, carry and empty 数据处理的输出长度、承载和空载的确认 (3) Qualify the function of saving data to corresponding folder. 数据保存到相应文件夹的功能确认。 Test for shutdown/ recovery 关机/恢复测试 (1) Check condition of the data acquisition before and after shutdown so as to 5.3.4.6 ensure that data have not been damaged or lost. 在系统关闭之前和之后检查数据采集的情况,确保数据没有损坏或丢失。 (2)Check the function of backup power supply, uninterruptible power supply, power adjuster and power generator. 检查备用电源的供应、不间断电源供应器、电力调节器和电力发电机。 (3)System breakdowns or failures should be made in accordance with system operation manual so as to ensure that back-up system should be provided. 系统故障和失败的时候,能够根据系统的操作手册提供系统备份。 Other function test 其他功能测试 Performance qualification (PQ) 5.3.4.7 性能确认 The purpose of PQ is that qualify the efficacy and stability of running process on 5.3.5 operational circumstance. Test items should be established in accordance with achieving desired result and duplicate qualification should be also carried out. PQ的目的是确认系统运行过程中的有效性和稳定性方面的情况。测试项目应确定跟期望达到的结果相一致、二次确认也应该执行。 If system is part of production, laboratory or utilities, PQ of system should be completed conformity with PQ of equipment (utilities). 如果系统是生产,实验室或公共设施系统的一部分,系统的PQ必须根据设备的PQ进行完整性测试。 If a manual system is being replaced by computerized and PLC control system, the 5.3.5.1 Approve/批准人: SOP No./编号:SOP01809 /01 Computerised System Validation Date/日期: Page No./页码:Page 9 of 14 计算机系统验证 two should be run in parallel. 当一个人工系统被电脑,PLC控制系统取代时,两者需要平行运行。 Regarding to production equipment, the test for product specification, such as assay, 5.3.5.2 test for packaging specification, etc, should be carried out so as to ensure that the all process control functions are effective. Tests should be carried out for at least 3 consecutive batches on the some production condition. 对于生产设备,要进行产品规格测试,如化验、包装规格测试等等,确保所有的过程控制功能都是有效的，应当在相同的生产的条件下进行至少3个连续批次的测试。 Monitoring for equipment of consecutive process disposal should be carried out, e.g. 5.3.5.3 index of clean-air system, such as dust particle, microorganism, temperature, humidity, air flow, pressure difference, air exchange frequency, etc, should be monitored during a period. 对设备的连续过程进行监控应当进行,如空气净化体系的指标,例如尘埃粒子、微生物、温度、湿度、风量、压差、换气频率等,应在一个周期内被监控。 Validation deviation 5.3.5.4 偏差验证 The disposal of system validation deviation can refer to < Validation Organization 5.3.6 and Implementation>. 处置系统偏差验证可参阅<验证组织和实施>。 Change control 变更控制 Change classification: change is composed of hardware change, software change 5.3.7 and change of critical parameters in database. 变更的分类:变更是由硬件变更、软件变更，和数据库的临界参数变更组成。 If change occurring, change control should be carried out so as to ensure that 5.3.7.1 system should be on validated status. 若发生变更,须进行变更控制，确保系统失重处于已验证状态 (1) Written application should be prepared by use department, including change 5.3.7.2 reason, evidence, and content and implementation protocol. 使用部门提交书面申请,包括变更原因,证据,内容和实施方案。 (2)Professional technologist, the head of relevant department and QA are responsible for assessing, reviewing and approving. 工艺主管,相关部门经理和QA负责评估、审查和批准。 (3) Whether revalidation should be taken or not should be on the basis of impacting Approve/批准人: SOP No./编号:SOP01809 /01 Computerised System Validation Date/日期: Page No./页码:Page 10 of 14 计算机系统验证 range. E.g. validation should be carried out for the parts of change which impacting the validated statues of computerized and PLC control system; sometimes revalidation should not be carried out after assessment if sufficient evidence can be provided. 是否需要再验证应该根据影响范围而定，如当变更的部分影响计算机,PLC控制系统的 验证状态时，应当对各变更部分进行验证; 如果经过评估可以提供充分的证据表明没有 影响，那么就不需要再验证,。 (4) The implementation should be carried out after change approved by relevant personnel and altering content of approved change should be forbidden . 须经有关人员批准的后再执行变更，不得更改批准后的变更内容。 (5) Influence of change to other relevant system should be taken into consideration, and assessment of influenced systems should be carried out, where necessary, revalidation should also be carried out for relevant systems. 对于变更对其他有关系统的影响，应当进行考核和系统评估,必要时, 相关系统还要进 行再验证。 (6) The records should be made or completed at the time each action is taken, such as change application, assessment, approval and revalidation, and in such a way that all changes are traceable. 记录在每时每刻都要进行,如变更申请、评估、审批和再验证,用这样一种方式保证所有 的变化可追踪。 Annex附录 None 无 Related Documents相关文件 6 SOP01801 Validation Organization and Implementation 7 验证的组织和实施 Approve/批准人: SOP No./编号:SOP01809 /01 Computerised System Validation Date/日期: Page No./页码:Page 11 of 14 计算机系统验证 我认为对计算机系统的验证主要应该做以下几点: 计算机系统的可行性报告、性能(硬件和软件)说明及测试要求。1. 计算机系统的设计文件(硬件和软件)。2. 计算机系统的单元和集成测试报告。3. 计算机系统的安装、运行、性能确认报告。4. 计算机系统相关人员的培训报告。5. 计算机系统各级用户的权限划分和设置记录。6. 计算机系统日常维护规程及记录。7. 计算机系统安全规程及相关备份记录。8. 电子签名的组成、使用范围和相关文件及记录。9. Approve/批准人: SOP No./编号:SOP01809 /01 Computerised System Validation Date/日期: Page No./页码:Page 12 of 14 计算机系统验证 年月日，发布《计算机化系统》(附录)和《确认与验证》(附录)两个附录，作为《药品生产质量管20150526CFDA78 理规范(年修订)》配套文件，年月日起施行。附录共页，六章，二十四条，其中处提到人的因 2010 20151217621素，充分体现人在《药品生产质量管理规范(年修订)》中的重要性，猎梯医药人才网小编特地采访了首批中国药品质2010 量受权人诗迈医药猎头谢诗明，谢总从质量管理及人力资源的角度，对新政解读如下:----CEO 一、目的:计算机化系统的采用目的是减少人为影响与差错，提高生产效率，减少人员污染，是生产现代化程序的体现，也是适合国际制药技术水平发展接轨的需国，近来也出现了因计算机化系统带来的一些负面影响。 二、原则:共三条，可概括为:设计合理，明确责任，不增加总体风险，确保产品质量与用药安全。 三、人员:人员管理规范，人员数量减少，重点是基层人员减少，但对人员素质明显提高，对管理人员的能力提高，对人员跨部门经验要求提高，对人员整体配合协调能力提高，对人员的职责分工与权限严格明确，对人员严格上岗培训与考核要求提高，以应对计算机化系统带来的新风险和过渡风险。 四、验证:要求严格按照要求实施验证，充分考虑潜在风险和不可预计风险。严格执行，风险可控，当须替代人工某一部分时，必须采用人工与计算机化平行运行的方式，作为测试和验证一部分。 五、安全:安全措施必将出台，如重点区域人员出入管理、防盗、防意外、小时监控、数据备份、故障、异常情况上报、24 Approve/批准人: SOP No./编号:SOP01809 /01 Computerised System Validation Date/日期: Page No./页码:Page 13 of 14 计算机系统验证 异常情况责任追究等措施与文件。 六、修改:监管部门必定会考虑到计算机化带来的造假风险与合理修改。 七、影响: 、设备工程部人员学历必须本科以上学历，对自动化、设备工程和新具有丰富的实战经验。1GMP 、质量管理人员要求提高，必须能够对商业化计算机软件质量具有审核能力，结合公司产品特点，对计算机化系统的风险具2 有识别能力。 、体系文件完善:根据验证情况，对质量管理体系文件进行完善。并进行风险评估。3GMP 、应对人员离职、换岗及电子签名、放行与本人的一致有更完善的管理。4 8 Revision History修订记录 Approve/批准人: SOP No./编号:SOP01809 /01 Computerised System Validation Date/日期: Page No./页码:Page 14 of 14 计算机系统验证 Effective Date SOP No. Change Contents 编号 修改内容 生效日期 New document SOP01802/01 / 新文件