计算机系统验证方案VIP专享

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Computerize...