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1、Validation PlanDocument Control InformationLocation: The version of this document is maintained in folder vfill in folder locationRevisio n HistoryTable 1 : Versio n HistoryVersio nDate of ReleaseDescripti on(Cha nge and Reas ons for Chan ge)Prepared byReviewed byApproved byTable of ContentsContents
2、Document Control Information 2Table of Contents 3List of Figures 4List of Tables 51 Introduction 61.1 Purpose 61.2 Scope 61.3 Definitions, Acronyms, and Abbreviations 72 Inputs and Output 92.1 Prerequisition 92.2 Further supporting Information 92.3 Outputs 93 Safety Strategy and Processes 103.1 Over
3、view 103.23.33.43.53.6Validation Test objectives 10Safety Validation (Item development life cycle) 10Safety Organization and R&R.Regressionstrategy错. 误!未定义书签. 14Validation Processes 114 Item Description 154.1 Item overview 154.1.1 System Component 154.2 Configuration 164.3 Calibration 165 Project Development and Validation schedule 175.1 Validation Test Plan 175.1.1 HARAControllability Validation 175.1.2 Safety Goal Validation 185.1.3 Long-term test 185.2 Test Methods information 195.3 Validation method for safety goal 206 Test Case and Acceptance Criteri.a 217 References 22