翻译后的计算化系统验证模板.docVIP

Authors Signature:授权者签名 Your signature indicates that this document has been prepared in accordance with existing project standards and adequately reflects the tasks and deliverables necessary for validation of the equipment name您的签名表明这份文件的准备符合现行项目标准并且充分反映人物u和可交付使用对设备名称验证的必要。Authored By:经授权：Typed/Printed Name, Title姓名，职称Signature签名Date日期Unit单位Reviewers Signature:审查员签名：Your signature indicates that, you have reviewed this document and that it accurately and completely reflects the tasks and deliverables necessary for validation of the equipment name.您的签名表明您已经审阅了这份文件，确认它精确并完全的反映任务和可交付使用对设备名称验证的必要。Reviewed By:经审阅：Typed/Printed Name, Title姓名，职称Signature签名Date日期Unit单位Typed/Printed Name, Title姓名，职称Signature签名Date日期Unit单位Typed/Printed Name, Title姓名，职称Signature签名Date日期Unit单位Quality Control/Compliance Approvers Signature:质检/承认签名Your signature indicates that this document complies with reference Validation Master Plan, company standards or guidelines; and that the documentation and information contained herein complies with applicable regulatory, corporate, divisional/departmental requirements, and current Good Manufacturing Practices.您的签名表明这份文件符合〈证明人验证总计划，企业标准或政策〉，并且在此包含的文件和信息符合可应用的可调整的，共同的以及部门所有的／部门的要求和现行的ＧＭＰ标准。Approved By:经核准：Typed/Printed Name, Title姓名，职称Signature签名Date日期Unit单位Typed/Printed Na me, Title姓名，职称Signature签名Date日期Unit单位Revision History修订历史纪录Revision修订本Revision Date修订日期Reason for Revision/Change Request修订/更改要求的原因Revised By修订人004-DEC12/4Original Release原始版本Michael T. Filary迈克尔116-JAN1/16Updated the JETT logo on the cover page.更新封页面的JETT的标识Michael T. Filary迈克尔Table of Contents目录 TOC \o 1-2 1. Introduction绪论 PAGEREF _To\h 51.1 Purpose目的 PAGEREF _To\h 51.2 Policy Compliance适用的政策 PAGEREF _To\h 51.3 Scope of Validation验证范围 PAGEREF _To\h 51.4 Objectives目标 PAGEREF _To\h 61.5 Periodic Review定期审查 PAGEREF _To\h 62. Organizational Structure组织结构 PAGEREF _To\h 73. GxP Critic