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User
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Admin
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R&D- Development mode only
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Routine
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Sign Off
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Audit
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Method management
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Create New
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ü
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Modify Method Meta Data
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ü
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Import room
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ü
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ü
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Import Data File
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ü
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ü
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Design New DFT
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ü
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Input Meta Data (if not present in data file)
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ü
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ü
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Development room
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ü
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Create / Edit Data Maps
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ü
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Create / Edit Analysis Definitions Including All Suitability Criteria
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ü
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Manage Versions of Data Maps and Analysis Definitions
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ü
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View Data
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ü
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Run Analysis
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ü
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Download Report (not for GxP use)
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ü
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Download Excel Format Results
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ü
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Create Entry In Development Record
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ü
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Download Development Report
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ü
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Submit A Fully Developed Method For Sign Off
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ü
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and data in Monitoring room
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ü
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Sign Off Room
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ü
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1st level authorisation to lock a Method (MCF)
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ü
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Download MCF for paper records
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ü
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Routine Room
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ü
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Run An Analysis Using A MCF On A Selected Data File
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ü
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Run a combine RP analysis
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ü
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Download Report For Regulatory Use (GxP , 21CFR Part 11 )
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ü
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Download Excel format results
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Start / stop Auto import
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ü
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Audit Room
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Read Audit Logs
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ü
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2nd sign off for MCF and Routine reports
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ü
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Run update audit process and report
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ü
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Admin Areas
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User Invitation
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ü
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Manage and update licenses
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ü
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Select single or dual sign off for MCF (Development to Routine)
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ü
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Manage User Settings and Permissions
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ü
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System Validation Checks in Routine Mode
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ü
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Load Import plugin modules
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ü
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