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 1of14 *** *******

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****（Longfengtang）

Computerized System Validation

设计确认

Design Qualification Plan 编制角色 Authorized Role 编制人 Drafted by 部门 Department 天甘科技 车间主任 制造部部长 审核人 Reviewed by 设备主管 IT主管 验证管理员 QA主管 批准人 Approved by 颁发部门： Issued Department 分发部门： Distribution Department 版本号： Version No.

签名 Signature 执行日期： Execution date A1 签名日期 Date 质量管理部部长 质量管理部 Quality Management Dept 修订历史

Revision History 版本号 更新日期 Version Updated Date No. 修订作者 Author 主要修订摘要 Abstract Validation 设计确认 Design Qualification A1 编号: No. 页码: Page PCS-DQ-VP-001-A1 2of14 批准版Approve

Validation 设计确认 Design Qualification 编号: No. 页码: Page PCS-DQ-VP-001-A1 3of14 目录Table of Contents

1 2 3 4 5 6 7

目的Purposes ................................................................................................................................... 4 缩略语Abbreviations ...................................................................................................................... 4 培训Training ................................................................................................................................... 4 测试说明和接受标准Test Instruction & Acceptance Criteria ................................................... 4 参考文件Reference ......................................................................................................................... 5 方案前提条件Protocol Pre-Requisites .......................................................................................... 5 测试总览Test Overview ................................................................................................................. 8 7.1 7.2 7.3 7.4 7.5 7.6

系统范围Test Script No. 1 – Site Wide .................................................................................... 9 编写Prepared by ........................................................................................................................ 9 测试完成Test Completion ........................................................................................................ 9 测试签名登记Tester Signature Register .................................................................................. 9 前提条件Pre-Requisites .......................................................................................................... 10 意见（签名/日期）Comments (Initial/Date) .......................................................................... 14

Validation 设计确认 Design Qualification 编号: No. 页码: Page PCS-DQ-VP-001-A1 4of14 1 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 Chinese medicine extraction workshop.

2 缩略语Abbreviations

缩略语Abbreviations DQ IQ OQ TRS DCS RA VP ERES QPP 描述Description 设计确认Design Qualification 安装确认Installation Qualification 运行确认Operational Qualification 技术需求说明Technical Requirement Specification 离散控制系统Distributed control system 风险评估Risk Assessment 验证计划Validation Plan 电子记录和电子签名Electrical Record and Electrical signature 质量和项目管理计划Quality and Project Management Plan 3 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 onbasic system operation andthis protocol prior to test execution.

4 测试说明和接受标准Test Instruction & Acceptance 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 completion. 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, pagination 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）