PCSDQVP001设计确认方案

1、*（Longfengtang） Computerized System Validation设计确认Design Qualification Plan编制角色Authorized Role部门Department签名Signature签名日期Date编制人Drafted by天甘科技审核人Reviewed by车间主任制造部部长设备主管IT主管验证管理员QA主管批准人Approved by质量管理部部长颁发部门：Issued Department质量管理部Quality Management Dept执行日期：Executiondate分发部门：Distribution Department版

2、本号：Version No.A1修订历史Revision History版本号Version No.更新日期Updated Date修订作者Author主要修订摘要AbstractA1批准版Approve目 录Table of Contents1目的Purposes42缩略语Abbreviations43培训Training44测试说明和接受标准Test Instruction & Acceptance Criteria45参考文件Reference56方案前提条件Protocol Pre-Requisites57测试总览Test Overview87.1系统范围Test Script No.

3、 1 Site Wide97.2编写Prepared by97.3测试完成Test Completion97.4测试签名登记Tester Signature Register97.5前提条件Pre-Requisites107.6意见（签名/日期）Comments (Initial/Date)141 目的Purposes本方案详细描述了*提取1号车间PCS系统设计确认的活动和文档。This protocol specifies the design qualification activities and documentation required for PCS system of Chin

4、ese medicine extraction workshop.2 缩略语Abbreviations缩略语Abbreviations描述DescriptionDQ设计确认Design QualificationIQ安装确认Installation QualificationOQ运行确认Operational QualificationTRS技术需求说明Technical Requirement SpecificationDCS离散控制系统Distributed control systemRA风险评估Risk AssessmentVP验证计划Validation PlanERES电子记录和电

5、子签名Electrical Record and Electrical signatureQPP质量和项目管理计划Quality and Project Management Plan3 培训Training在测试执行前，测试人员以及供应商的支持测试人员都应该经过培训。Tester/s and vendor/s supporting test execution shall be trained on basic system operation and this protocol prior to test execution.4 测试说明和接受标准Test Instruction & Ac

6、ceptance Criteria DQ的测试范围如测试总览所列。包含了DQ交付物的确认。测试完成后允许系统放行到下一步项目阶段。详细的测试说明已经在各自的测试脚本内显示。测试脚本中的所有测试步骤都应该完成。An overview of DQ test scope is listed in Test Overview. It covers verification of DQ deliverables.This allows the release of system by process area to subsequent project phase upon test completio

7、n.Detailed test instructions are provided in the respective test scripts. All test steps in the test script shall be completed. 在测试执行中生成的所有的附件应该规范标记（附件号，方案文件号，页码和签名/日期）All attachments generated during test execution shall be properly labeled (with attachment number, protocol document number, paginat

8、ion and initial/date) and recorded in the attachment log.如下表示附件号：Attachment number shall be denoted as follows:测试脚本号-步骤-Attxx（xx表示该步骤的附件顺序号）Test script number-Step #-Attxx (where xx denotes running sequential number of a specific step)例如Examples: 主文件：1-Att01For Main protocol: 1-Att01测试脚本：TS01-1-Att0

9、1For Test script: TS01-1-Att01测试完成后，执行的测试脚本应该由主题专家和项目经理来审核其完整性和技术的合规性Upon test completion, each executed test script shall be reviewed by SME and PM for completeness and technical compliance. 验证QA根据测试脚本的审核结果及相关偏差的处理结果对此验证文件进行批准、放行。The release of system shall be approved by QA validation in Test Over

10、view based on the reviewed test script and any outstanding deviation5 参考文件Reference 文件编号Document ID文件名称Document namePCS-QPP-001质量和项目管理计划Quality and Project Management planPCS-DMP -001文档管理规程Document Management ProcedurePCS-TRS-001技术需求规范Technoical Requirements SpecificationPCS-ERES-001电子记录和电子签名Electri

11、cal Record and Electrical SignaturePCS-RA-001风险评估Risk Assessment6-00001验证管理规程Validation Management Procedure7-00001计算机化系统管理规程Computerized System Management Procedure6 方案前提条件Protocol Pre-Requisites 在脚本测试执行前，前提条件必须满足Pre-requisites must be met prior to test scripts execution. 编号Item No.描述Description确认？

12、（是/否）Conformed? (Yes / No)签名/日期Initial / Date1确认TRS Verification TRS 已经批准TRSVerify that TRS has been approved.记录文件名称，版本和批准日期Record the document reference, revision and approval date.Yes / No_文件名称:Document reference_版本:Revision_批准日期Approval date_2确认QPP Verification QPP 文件已经批准QPP Verify that QPP has b

13、een approved.记录文件，版本和批准日期Record the document reference, revision and approval date.Yes / No_文件名称:Document reference_版本:Revision_批准日期Approval date_3VP 确认VP Verification确认VP已经被批准Verify that VP has been approved.记录文件名称，版本和批准日期Record the document reference, revision and approval date.Yes / No_文件名称:Docum

14、ent reference_版本:Revision_批准日期:Approval date_4RA 确认RA Verification 确认风险评估（RA）已批准Verify that Risk Assessment (RA) has been approved.记录文件名称，版本和批准日期Record document reference, revision and approval date.Yes / No_文件名称:Document reference_版本:Revision_批准日期:Approval date_5ERES确认ERES Verification 确认电子记录和电子签名（

15、ERES）评估已经被批准Verify that Electronic Record and Electronic Signature (ERES) Assessment has been approved.记录文件名称，版本和批准日期Record document reference, revision and approval date.Yes / No_文件名称:Document reference_版本:Revision_批准日期:Approval date_7 测试总览Test Overview确认阶段Qualification PhaseDQ 设计确认 IQ安装确认OQ 运行确认项目

16、名称Project Name提取1号车间自动化系统项目风险评估参考RA ReferencePCS-RA-001测试编号Test No.测试脚本名称Test Script Title测试脚本编号Test Script No.测试脚本版本Test Script Rev. No.测试完成？（是/否）Test Completed? (Y/N)偏差编号/关闭日期Deviation No./Closure date签名/日期Initial/Date1.系统范围Site WideTS017.1 系统范围Test Script No. 1 Site Wide 确认阶段Qualification Phase 设

17、计确认DQ 安装确认 IQ运行确认OQ 项目名Project Name 提取1号车间自动化系统项目7.2 编写Prepared by 姓名Name 职位Function 职责Justification 签名Signature 日期Date 验证工程师Validation engineer作为编写人签名For signature of author7.3 测试完成Test Completion 姓名Name 职位Function 职责Justification 签名Signature 日期Date 测试者Tester作为确认者签字Signed as Verifier业主审核人System own

18、er reviewer作为审核者签字Signed as Reviewer7.4 测试签名登记Tester Signature Register 姓名Name职位Title公司Company签名Signature日期Date7.5 前提条件Pre-Requisites 脚本测试执行前，前提条件必须满足Pre-requisites must be met prior to test scripts execution. 编号Item No. 描述Item Description 确认（是/否）Conformed? (Y/N)签名/日期Initial/Date附件编号（如果适用）Attachment

19、 No. (where applicable)1附上风险评估的复印件Attach a copy of Risk Assessment (RA). 附件:Attachment _步骤Step 行动#价值Action & Value实际结果Actual Result通过/失败Pass/Fail*如果失败，标明偏差号State Deviation No. if test fails签名/日期Initial/ Date1FS确认FS Verification 确认功能设计规格书已批准Verify that Functional Design Specifications as per expected

20、 result has been approved.记录文件名称，版本和批准日期Record document reference, revision and approval date.HDS确认HDS Verification 确认硬件设计规格书已批准Verify that Hardware Design Specifications as per expected result has been approved.记录文件名称，版本和批准日期Record document reference, revision and approval date.SDS确认SDS Verification 确认软件设计规格书已批准Verify that Soft