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/年

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。

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

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.