计算机系统验证方案.docx

Computerised System Validation 计算机系统验证 Dept. 部门： QA Effective Date  质量保证部 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 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 2 3 4 5 5.1 5.1.1 5.1.2 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。 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。 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。 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