计算机系统验证sop,中英对照-计算机系统验证SOP.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 PAGE 6 of NUMPAGES 12

PAGE 6

SOP No./编号: SOP01809/01

Page No./页码: Page PAGE 1 of NUMPAGES 12

Any unauthorized use and copy is forbidden.

未经授权，不得使用或拷贝。

Computerised System Validation

计算机系统验证

质量保证部QADept.

质量保证部

QA

部门：

Date/日Effective Date

Date/日

Month/月Year/年生效日期：

Month/月

Year/年

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