■Planning 計劃
● URS 用戶需求說明
● Quality and Verification Plan
質(zhì)量與驗證計劃
■ Specification 規(guī)范
● Functional Specification 功能規(guī)范
● Hardware Design Specification 硬件設(shè)計規(guī)范
● Software Design Specification 軟件設(shè)計規(guī)范
● Software Module Specification 軟件模塊規(guī)范
● Design Qualification 設(shè)計確認
■ Verification 驗證
● FAT Protocol & Execution FAT方案和執(zhí)行
● SAT Protocol & Execution SAT方案和執(zhí)行
● IQ Protocol & Execution IQ方案和執(zhí)行
● OQ Protocol & Execution IQ方案和執(zhí)行
● Data Integrity and Access Control
數(shù)據(jù)可靠性和訪問控制
● Disaster Recovery and Business Continuity
災難恢復和業(yè)務連續(xù)性
● PQ Protocol & Execution IQ方案和執(zhí)行
■ Verification Report 驗證報告
● Commissioning/Validation Summary Report
調(diào)試驗證總結(jié)報告
● Software Change Control Tracking Report
軟件變更控制追蹤報告
● Project Summary Report
項目總結(jié)報告