LabChip GX/GXII User Manual

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Software Security 90Software SecurityA 21 CFR Part 11 Compliance option is available for the LabChipGX software. This option ensures that assays, output data, analysissettings, event data, and backup data files are not available forediting or tampering. Data is stored in a secure folder on the localcomputer. To create and maintain the Audit Log and LabChip GXuser accounts, Microsoft SQL Server 2005 Express is provided withthe LabChip 21 CFR Part 11 option.The following procedures are included in this section:“Locking and Unlocking the Software” on page 92“Managing User Accounts” on page 93• “Adding New Users” on page 94• “Changing User Information” on page 95• “Printing User Information” on page 96• “Activating and Deactivating User Accounts” on page 96• “Changing Access Rights” on page 97• “Printing Access Rights” on page 98• “Setting Policies for User Accounts” on page 99• “Printing User Policies” on page 100“Electronic Signatures” on page 101“Automatically Exporting Copies of Data Files” on page 102“Reverting to a Specific Data File Revision” on page 102“Audit Trail” on page 103• “Viewing the Audit Trail” on page 104• “Exporting the Audit Trail” on page 105“Central Data Repository (CDR)” on page 106• “CDR Security Suggestions” on page 106• “Creating New Data Folders” on page 107• “Moving Data Files into Folders” on page 107• “Deleting Data Folders” on page 107• “Hiding Data Files in the CDR Manager Window” on page 108• “Showing Hidden Data Files in the CDR Manager Window” onpage 108“Remote CDR Server Backup” on page 109• “Setting Up the Remote CDR Server” on page 109P/N 127170 Rev. 00 LabChip GX User Manual Caliper Life Sciences, Inc.
Software Security 91• “Backing Up Data Files to the Remote CDR” on page 111“Running Installation Qualification (IQ)” on page 112“Running Operational Qualification (OQ)” on page 112P/N 127170 Rev. 00 LabChip GX User Manual Caliper Life Sciences, Inc.
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LabChipGX/GX IIUser ManualCopyright
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Preface 3For support in Europe cont
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Preface 5Table 1. Important Symbols
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Instrument Safety 7Required Trainin
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Instrument Safety 9Laser SafetyWARN
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Instrument Safety 11InternationalAl
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Table of Contents 13Viewing the EFs
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Table of Contents 15Login Window...
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Introduction 17IntroductionThis man
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Introduction 19Principles of Operat
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Operation 21OperationThis section i
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Operation 23Running an AssayTo star
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Operation 25Running an Assay (Conti
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Operation 27Monitoring the RunThe f
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Operation 29Continuing a Stopped Ru
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Operation 31Saving Data Files (Cont
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Operation 33Adding a New Plate (Con
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Data Analysis 35Data AnalysisAfter
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Data Analysis 37How the Software An
Page 39 and 40: Data Analysis 39How the Software An
Page 51 and 52: Data Analysis 51Opening a Data File
Page 53 and 54: Data Analysis 53Selecting the Wells
Page 55 and 56: Data Analysis 55To import the sampl
Page 57 and 58: Data Analysis 57Using Expected Frag
Page 59 and 60: Data Analysis 59Forcing Expected Pe
Page 61 and 62: Data Analysis 61Viewing the EFs/EPs
Page 63 and 64: Data Analysis 63Changing the Peak F
Page 65 and 66: Data Analysis 65Merging Two PeaksIf
Page 67 and 68: Data Analysis 67Using the Default L
Page 69 and 70: Data Analysis 69Upper and Lower Mar
Page 71 and 72: Data Analysis 71Lower Marker Peaks
Page 73 and 74: Data Analysis 73Viewing GelsTo comp
Page 75 and 76: Data Analysis 75Adjust Pane WidthsT
Page 77 and 78: Data Analysis 77Viewing Graphs in t
Page 79 and 80: Data Analysis 79Viewing Multiple Pr
Page 81 and 82: Data Analysis 81Reanalyzing a Data
Page 83 and 84: Data Analysis 83ElectropherogramCho
Page 85 and 86: Data Analysis 85Peak TableChoosing
Page 87 and 88: Data Analysis 87Raw DataASCII text
Page 89: Data Analysis 89Exporting Data Manu
Page 93 and 94: Software Security 93Managing User A
Page 95 and 96: Software Security 95Changing User I
Page 97 and 98: Software Security 97Changing Access
Page 99 and 100: Software Security 99Setting Policie
Page 101 and 102: Software Security 101Electronic Sig
Page 103 and 104: Software Security 103Audit TrailLab
Page 105 and 106: Software Security 105Exporting the
Page 107 and 108: Software Security 107Creating New D
Page 109 and 110: Software Security 109Remote CDR Ser
Page 111 and 112: Software Security 111Backing Up Dat
Page 113 and 114: Software Reference 113Software Refe
Page 115 and 116: Software Reference 115Menu BarThe m
Page 117 and 118: Software Reference 117Collection Me
Page 119 and 120: Software Reference 119Security Menu
Page 121 and 122: Software Reference 121Chip Status a
Page 123 and 124: Software Reference 123Error Message
Page 125 and 126: Software Reference 125Rename Plate
Page 127 and 128: Software Reference 127Collection Pa
Page 129 and 130: Software Reference 129Graph View (C
Page 131 and 132: Software Reference 131Active Data T
Page 133 and 134: Software Reference 133Electropherog
Page 135 and 136: Software Reference 135OptionText Or
Page 137 and 138: Software Reference 137Gel View (Con
Page 139 and 140: Software Reference 139Gel View Prop
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Software Reference 141Peak Table Vi
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Software Reference 147Filter ViewTh
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Software Reference 149Filter View (
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Software Reference 151Add New Expec
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Software Reference 153Assay Analysi
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Software Reference 155Alignment Tab
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Software Reference 157Analysis Tab
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Software Reference 159Peak Find Tab
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Software Reference 161Table 2. Well
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Software Reference 163Expected Frag
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Software Reference 165Excluded Peak
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Software Reference 167Smear Analysi
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Software Reference 169Titer Tab (Co
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Software Reference 171Advanced TabU
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Software Reference 173Audit Trail W
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Software Reference 175Audit Trail M
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Software Reference 177DeleteButtonH
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Software Reference 179CDR Utility W
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Software Reference 181Change Passwo
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Software Reference 183Event Viewer
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Software Reference 185Export Window
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Software Reference 187Installation
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Software Reference 189Login WindowU
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Software Reference 191Perform Signa
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Software Reference 193Print WindowU
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Software Reference 195Print Validat
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Software Reference 197Run File Edit
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Software Reference 199Sample Name E
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Software Reference 201Save Workspac
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Software Reference 203Start Run Win
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Software Reference 205Run Tab (Cont
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Software Reference 207Output Tab (C
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Software Reference 209Advanced Tab
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Software Reference 211System Diagno
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Software Reference 213User Administ
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Software Reference 215Edit UsersUse
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Software Reference 217De/Activate U
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Software Reference 219Show/Hide in
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LabChip GX Instrument Description 2
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Maintenance and Service 231Maintena
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Troubleshooting and Diagnostics 233
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Glossary of Terms 247Glossary of Te
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Glossary of Terms 249CLAThe file ex
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Glossary of Terms 251Data Filtering
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Glossary of Terms 253GXD FilesThe f
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Glossary of Terms 255Figure 115. Sl
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Glossary of Terms 257Ladder Analysi
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Glossary of Terms 259Peak BaselineA
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Glossary of Terms 261Polynomial Ord
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Glossary of Terms 263For the purpos
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Glossary of Terms 265SmearSpecifies
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Glossary of Terms 267Figure 120. Pr
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Glossary of Terms 269WorkspaceZero
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Caliper Life Sciences, Inc. Product
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Caliper Life Sciences, Inc. Softwar
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Index 275IndexNumerics21 CFR Part 1
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Index 277showing. . . . . . . . . .
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Index 279clearing default ladder .
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Index 281Remote CDR Server . . . .
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Index 283Waste wells . . . . . . .
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LabChip GX/GXII User Manual

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