计算机系统验证方案.doc

Computerised System Validation
计算机系统验证
Approve/批准人：
SOP No./编号：SOP01809 /01
Date/日期：
Page No./页码：Page 12 of 12

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Computerised System Validation
计算机系统验证
Approve/批准人：
SOP No./编号：SOP01809 /01

Date/日期：
Page No./页码：Page 6 of 12

6

SOP No./编号: SOP01809/01
Page No./页码: Page 1 of 12

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Computerised System Validation

计算机系统验证

质量保证部
QA
Dept.
部门：

Date/日

Effective Date
Month/月
Year/年
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.
部门
QA
QC
OSP
Lo.
EN
TD
EQ
QD
Name
姓名

Signature签名

Date
日期

1
Objective 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 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。
2
Scope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 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, 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 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,它应该被翻译成可以被计算机识别的机器语言。
5
Procedures 程序
5.1

5.1.1

5.1.2

Organization 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,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 system so 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:

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. DOS\Windows 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 (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 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 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 code

System 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 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

5.2.2
Some 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。
5.2.3
Validation 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 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。
5.3
Validation implementation
验证实施
5.3.1
URS

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、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:

5.3.1.1
System description: what to do about system, how connection and interaction 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。
5.3.1.2
Physical 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。
5.3.1.3
Document 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。
5.3.1.4
Document 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。
5.3.1.5
Test requirement: test 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, 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。
5.3.2
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。
5.3..3
IQ

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:
5.3.3.1
Document 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, 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。
5.3.3.2
Installation 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。
5.3.3.3
Circumstance and utilities qualification
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。
5.3.3.4

System test and qualification
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:

5.3.4
l All instruments and meters should be calibrated and on expire day of calibration. Calibration should be fit for definite criteria and corresponding certification should 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。
l I/O (input/output) signal test should be carried out so as to ensure that single can 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。
l Data acquisition and transmission and signal memory test
数据采集,传送和信号记忆测试
l Other tests
l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

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
5.3.4.6
(1) Check condition of the data acquisition before and after shutdown so as to ensure that data have not been damaged or lost.
在系统关闭之前和之后检查