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

1 Objective 目的

Year/Month/月 QA 质量保证部 Date/日

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。

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 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, 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 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。

5Procedures 程序

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

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.

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

系统分级

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: