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验证总计划模板ValidationMasterPlanTemplate.pdf

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验证主计划 版本Rev.No.:01 ValidationMasterPlan 文件编号Doc.ID#:生效日期EffectiveDate:页码Page1of16 验证主计划 ValidationMasterPlan 起草人Preparedby 部门Department打印体姓名PrintName签字/日期Signature/Date 质量部Quality 审核人Reviewedby 部门Department打印体姓名PrintName签字/日期Signature/Date 工程设备部 EngineeringEquipment 生产部 Production 质量控制 QualityControl 质量保证 QualityAssurance 批准人Approvedby 角色Role打印体姓名PrintName签字/日期Signature/Date 质量管理负责人 HeadofQualityManagement 生效Effective 生效日期 EffectiveDate 注：签名表示已对文件的准确性和完整性进行了审核并符合相关要求。 Note:Signatureonthispageindicatethedocumenthasbeenreviewedforaccuracyandcompleteness. 验证主计划 版本Rev.#:01 ValidationMasterPlan 文件编号Doc.ID#:页码Page2of16 目录Contents 1.项目介绍ProjectIntroduction...................................................................................................3 2.目的Purpose.............................................................................................................................3 3.适用范围Scope.........................................................................................................................3 4.参考文献ReferenceDocuments.................................................................................................4 5.验证职责ValidationResponsibilities..........................................................................................5 6.缩略语Abbreviations.................................................................................................................7 7.产品及工艺描述ProductandProcessDescription......................................................................8 8.设施、设备、仪器、系统描述Facility\Equipment\Instrument\SystemDescription.................8 9.验证原则ValidationPolicy.........................................................................................................9 10.验证策略ValidationStrategy.....................................................................................................9 11.验证文件ValidationDocument...............................................................................................