— 分析URS 及其可行性分析

— 项目计划Project Plan (Gantt)

— 质量计划Quality Plan (QP)

— 设计确认，含Design Qualification (DQ)

— 外形尺寸图(GAD) ,P&ID  

— 公共工程界面协议 (UIA)

— 软件界面协议(SIA)  Software Interface Agreement

— 电路图(ED)  Electrical Diagram

— 气动图 (PD) Pneumatic Diagram

— 材料清单 (BOM)  Bill of materials/components

— 功能说明 Functional Design Specification (FDS)

— 软件设计说明 Software Design Specification (SDS)

— 硬件设计说明 Hardware Design Specification (HDS)

— 安装及用户手册 Installation  User and Maintenance Manual

— 设备及软件验证手册 Machine and software Validation Manual (MSVM)

— 焊接手册 Welding Validation Manual (WVM)

— 工厂预验收测试 Factory Acceptance Test (FAT)

— 现场验收测试 Site Acceptance Test (SAT)

— 设备定位，安装，启动 Machine positioning, Installation, Start-up

— 安装及操作确认(IQ & OQ) Installation and operation qualification (IQ & OQ)

— 培训课程 Training courses

— 预防性保养计划 Program of preventive maintenance

— 零件及耗材清单 Spare parts and consumable products list