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■Planning 打算

● URS 用户需要申明

● Quality and Verification Plan

品质与考证打算

■ Specification 标准

● Functional Specification 功效标准

● Hardware Design Specification 硬件设想标准

● Software Design Specification 软件设想标准

● Software Module Specification 软件模块标准

● Design Qualification 设想确认

■ Verification 考证

● FAT Protocol & Execution FAT计划和履行

● SAT Protocol & Execution SAT计划和履行

● IQ Protocol & Execution IQ计划和履行

● OQ Protocol & Execution IQ计划和履行

● Data Integrity and Access Control

数据靠得住性和拜候节制

● Disaster Recovery and Business Continuity

灾害规复和营业持续性

● PQ Protocol & Execution IQ计划和履行

■ Verification Report 考证报告

● Commissioning/Validation Summary Report

调试考证总结报告

● Software Change Control Tracking Report

软件变革节制追踪报告

● Project Summary Report

名目总结报告

计较机体系考证CSV

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