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 5of14 Test script number-Step #-Attxx (where xx denotes running sequential number of a specific step) 例如Examples:

主文件：1-Att01

For Main protocol: 1-Att01 测试脚本：TS01-1-Att01 For 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 Overview based on the reviewed test script and any outstanding deviation

5 参考文件Reference

文件编号Document ID PCS-QPP-001 PCS-DMP -001 PCS-TRS-001 PCS-ERES-001 PCS-RA-001 6-00001 7-00001 文件名称Document name 质量和项目管理计划Quality and Project Management plan 文档管理规程Document ManagementProcedure 技术需求规范Technoical Requirements Specification 电子记录和电子签名Electrical Record and Electrical Signature 风险评估Risk Assessment 验证管理规程Validation ManagementProcedure 计算机化系统管理规程Computerized System ManagementProcedure 6 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 描述 确认？（是/否）签名/日期 Item No. Description Conformed?(Yes / No) Initial / Date Validation 设计确认 Design Qualification 描述 Description 确认TRS Verification TRS 已经批准TRS Verify 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. 编号: No. 页码: Page PCS-DQ-VP-001-A1 6of14 签名/日期 Initial / Date 编号 Item No. 1 确认？（是/否）Conformed?(Yes / No) Yes / No ____________________ 文件名称: Document reference ____________________ 版本: Revision ____________________ 批准日期 Approval date ____________________ Yes / No ____________________ 文件名称: Document reference ____________________ 版本: Revision ____________________ 批准日期 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 been approved. 记录文件，版本和批准日期 Record the document reference, revision and approval date. 3 VP 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. Validation 设计确认 Design Qualification 描述 Description RA 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. 编号: No. 页码: Page PCS-DQ-VP-001-A1 7of14 签名/日期 Initial / Date 编号 Item No. 4 确认？（是/否）Conformed?(Yes / No) 5 Yes / No ____________________ 文件名称: Document reference ____________________ 版本: Revision ____________________ 批准日期: Approval date ____________________ Yes / No ERES确认ERES Verification 确认电子记录和电子签名（ERES）评____________________ 文件名称: 估已经被批准 Document reference Verify that Electronic Record and Electronic Signature (ERES) Assessment ____________________ 版本: has been approved. Revision 记录文件名称，版本和批准日期 Record document reference, revision and ____________________ 批准日期: approval date. Approval date ____________________ Validation 设计确认 Design Qualification 编号: No. 页码: Page PCS-DQ-VP-001-A1 8of14 7

测试总览Test Overview

确认阶段 DQ 设计确认 IQ安装确认OQ 运行确认 Qualification Phase 项目名称 提取1号车间自动化系统项目 ProjectName PCS-RA-001 风险评估参考 RA Reference 测试编测试脚本名称 测试脚本测试脚本测试完成？ 偏差编号/Test Script 号 编号 版本 （是/否） 关闭日期 Title Test Test Script Test Script Test Completed? Deviation No. No. Rev. No. (Y/N) No./Closure date 1. TS01 系统范围 Site Wide 签名/日期 Initial/Date