计算机系统验证方案-中英.docVIP

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 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. 根据本SOP，对URS、设计、采购、安装、功能以及GMP相关的计算机控制和PLC控制系统进行测试评估，以确保计算机和PLC符合设计要求和工艺要求并且能够长时间稳定工作。 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GMP相关计算机,PLC控制系统的验证管理，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 b