PCS-DQ-VP-001- 设计确认方案-A1

Validation 设计确认 Design Qualification 编号: No. 页码: Page PCS-DQ-VP-001-A1 9of14 7.1 系统范围Test Script No. 1 – Site Wide 确认阶段Qualification Phase 项目名ProjectName 7.2

编写Prepared by

职位Function 验证工程师 Validation engineer 测试完成Test Completion

职位Function 测试者 Tester 业主审核人 System owner reviewer 职责Justification 作为确认者签字 Signed as Verifier 作为审核者签字 Signed as Reviewer 签名Signature 日期Date 职责Justification 作为编写人签名 For signature of author 签名Signature 日期Date 设计确认DQ 安装确认 IQ提取1号车间自动化系统项目 运行确认OQ 姓名Name 7.3

姓名Name 7.4

测试签名登记Tester Signature Register

姓名 Name 职位 Title 公司 Company 签名 Signature 日期 Date Validation 设计确认 Design Qualification 编号: No. 页码: Page PCS-DQ-VP-001-A1 10of14 7.5 前提条件Pre-Requisites

附件编号（如果适用） Attachment No. (where applicable) 附件:Attachment ____________________ 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）签名/日期 Conformed? (Y/N) Initial/Date 1 附上风险评估的复印件Attach a copy of Risk Assessment (RA). Validation 设计确认 Design Qualification 编号: No. 页码: Page PCS-DQ-VP-001-A1 11of14 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/ Date FS确认 FS Verification 确认功能设计规格书已批准 Verify that Functional 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. HDS确认 HDS Verification 确认硬件设计规格书已批准 Verify that HardwareDesign 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. 功能设计FS Functional DesignFS 文件名称Document reference: ____________________ 版本Revision: ____________________ 批准日期Approval date: ____________________ 硬件HDS Hardware HDS 文件名称Document reference: _____________________ 版本Revision: _____________________ 1 Validation 设计确认 Design Qualification 编号: No. 页码: Page PCS-DQ-VP-001-A1 12of14 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/ Date SDS确认SDS Verification 确认软件设计规格书已批准 批准日期Approval date: _____________________ 软件SDS Software SDS _____________________ Verify thatSoftware Design Specifications as per 文件名称Document reference: expected result has been approved. _____________________ 记录文件名称，版本和批准日期 版本Revision: Record document reference, revision and approval date. _____________________ 批准日期Approval date: _____________________ 附件Attachment: 2 DQ（系统范围内）