计算机系统验证方案.docxVIP

Computerised System Validation 计算机系统验证 Dept. 部门： Effective Date 生效日期： Year/ Month/月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 Objective 目的 QA 质量保证部 Test and assessment should be taken for URS, design, purchase, installation, function, as well as process adaptability of computerizeDdataen/日d 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