Software Manual Freedom EVOware Standard 2.3 Freedom ...

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B - Appendix B - FDA 21 CFR Part 11 Compliance Part A - General Provisions B.6.1.1 § 11.1(a) Criteria Compliance Freedom EVOware The features implemented in Freedom EVOware that deal with electronic records and electronic signatures are described in detail in the following sections and in B.5.5 “Electronic Signatures”, B-9. Compliance Tecan Customer Tecan customers must develop a procedure to establish criteria under which electronic records, electronic signatures and handwritten signatures executed on electronic records are considered to be trustworthy, reliable and generally equivalent to paper records and handwritten signatures. B.6.1.2 § 11.1(b) Records In Electronic Form Compliance Freedom EVOware Freedom EVOware uses specified directories to store process data, the trace file (audit trail) and the log files. A default directory structure is created for these files when Freedom EVOware is first installed. See A.5 “Freedom EVOware Directory Structure and Files”, A-25 for a list of the files and directories which are used. See also B.5.6 “Trace File (Audit Trail)”, B-10. If required, users with Freedom EVOware Administrator or Application Specialist rights can configure Freedom EVOware to use other directories (including network directories) for storing data, log and output files. See 8.3.1.4 “Protocol Options Tab”, 8-8. Compliance Tecan Customer Tecan customers must develop a procedure to document which records in electronic form are created, modified, maintained, archived, retrieved or transmitted and where the records are stored on the computer system. This does not apply to paper records that are transmitted by electronic means. B.6.1.3 § 11.1(c) Electronic Signatures Compliance Freedom EVOware Freedom EVOware uses electronic signatures on data and configuration files. See B.5.5 “Electronic Signatures”, B-9 for more information. Compliance Tecan Customer Tecan customers must develop a procedure to identify where electronic signatures and their associated electronic records are equivalent to handwritten signatures. B.6.1.4 § 11.1(d) Electronic Records Compliance Freedom EVOware Freedom EVOware uses specified directories to store process data, the trace file (audit trail) and the log files. A default directory structure is created for these files when Freedom EVOware is first installed. See A.5 “Freedom EVOware Directory Structure and Files”, A-25 for a list of the files and directories which are used. See also B.5.6 “Trace File (Audit Trail)”, B-10. If required, users with Freedom EVOware Administrator or Application Specialist rights can configure Freedom EVOware to use other directories (including network directories) for storing data, log and output files. See 8.3.1.4 “Protocol Options Tab”, 8-8. B - 12 Freedom EVOware Software Manual, 393172, en, V2.3
B - Appendix B - FDA 21 CFR Part 11 Compliance Part A - General Provisions Compliance Tecan Customer Tecan customers must specify where electronic records are used instead of paper records. B.6.1.5 § 11.1(e) Computer Systems Compliance Freedom EVOware As an important tool for quality assurance, Tecan has developed detailed guidelines and rules for all phases of hardware and software development and testing. Compliance Tecan Customer Tecan customers must name the computer systems (hardware and software) and the documents which will be made available for FDA inspections. B.6.2 § 11.2 Implementation B.6.2.1 § 11.2(a) Required Records Compliance Freedom EVOware Freedom EVOware uses specified directories to store process data, the trace file (audit trail) and the log files. A default directory structure is created for these files when Freedom EVOware is first installed. See A.5 “Freedom EVOware Directory Structure and Files”, A-25 for a list of the files and directories which are used. See also B.5.6 “Trace File (Audit Trail)”, B-10. If required, users with Freedom EVOware Administrator or Application Specialist rights can configure Freedom EVOware to use other directories (including network directories) for storing data, log and output files. 8.3.1.4 “Protocol Options Tab”, 8-8. Compliance Tecan Customer Tecan customers must keep copies of all records which are required for FDA inspections and establish reliable procedures to make all technical processes comprehensible and understandable. B.6.2.2 § 11.2(b) Submitted Records Compliance Freedom EVOware Freedom EVOware uses specified directories to store process data, the trace file (audit trail) and the log files. A default directory structure is created for these files when Freedom EVOware is first installed. See A.5 “Freedom EVOware Directory Structure and Files”, A-25 for a list of the files and directories which are used. See also B.5.6 “Trace File (Audit Trail)”, B-10. If required, users with Freedom EVOware Administrator or Application Specialist rights can configure Freedom EVOware to use other directories (including network directories) for storing data, log and output files. See 8.3.1.4 “Protocol Options Tab”, 8-8. Compliance Tecan Customer Tecan customers must keep copies of all records which are required for FDA inspections and provide reliable procedures to make all technical processes comprehensible and understandable. Freedom EVOware Software Manual, 393172, en, V2.3 B - 13
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Software Manual Freedom EVOware ®
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Table of Contents Table of Contents
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Table of Contents 6 Menus 6.1 File
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Table of Contents 8 Configuration T
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Table of Contents 9 Specifying Your
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Table of Contents 11 Getting Starte
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Table of Contents 13.2.40 Commands
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Table of Contents 15.30.2 Serial Di
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Table of Contents 15.68.10 MCA96 Mo
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Table of Contents 16.6.12 Columbus
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Table of Contents 16.27.3 Safire Re
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Table of Contents 17 Special Featur
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Table of Contents 19 Customer Suppo
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Table of Contents B Appendix B - FD
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1 - About This Manual 1 About This
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1 - About This Manual Reference Doc
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1 - About This Manual Context-Sensi
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2 - Safety User Qualification 2 Saf
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2 - Safety Specific Hazards 2.4 Spe
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2 - Safety Safety Features of the P
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2 - Safety Specific Safety Rules op
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3 - Product Description Overview of
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3 - Product Description Intended Us
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3 - Product Description Supported P
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3 - Product Description Computer Re
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4 - Installation Before You Start 4
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4 - Installation Installing Freedom
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4 - Installation Modifying, Removin
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4 - Installation Modifying, Removin
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4 - Installation Installing the USB
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4 - Installation Installing the USB
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5 - Starting Freedom EVOware Login
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5 - Starting Freedom EVOware Login
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5 - Starting Freedom EVOware Startu
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5 - Starting Freedom EVOware Startu
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5 - Starting Freedom EVOware Overvi
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6 - Menus File Menu 6 Menus This ch
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6 - Menus File Menu 6.1.2 Open Free
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6 - Menus File Menu Views Right cli
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6 - Menus File Menu Freedom EVOware
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6 - Menus View Menu 6.2.3 Cut / Cop
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6 - Menus Execute Menu Freedom EVOw
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6 - Menus Execute Menu Fig. 6-6 Set
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6 - Menus Administrator Menu 6.4.6.
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6 - Menus Help Menu 6.6 Help Menu T
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6 - Menus Freedom EVOware Toolbar R
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6 - Menus Freedom EVOware Toolbar D
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7 - Tecan User Management System 7
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8 - Configuration Tool Toolbar Butt
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8 - Configuration Tool Backing Up a
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8 - Configuration Tool General Sett
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8 - Configuration Tool Device Setti
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8 - Configuration Tool Device Drive
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9 - Specifying Your Instrument Setu
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10 - Configuring Liquid Classes Liq
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11 - Getting Started - Setting Up a
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12 - Running Scripts and Processes
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13 - Overview of Freedom EVOware Co
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14 - Advanced Programming Features
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15 - Script Commands Aspirate Comma
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15 - Script Commands Mix Command Lo
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15 - Script Commands Pick Up DITIs
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15 - Script Commands Detect Liquid
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15 - Script Commands Te-Fill Aspira
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15 - Script Commands Activate PMP C
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15 - Script Commands Tip Alignment
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15 - Script Commands Worklist Impor
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15 - Script Commands Export Data Co
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15 - Script Commands Manual Tip Ali
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15 - Script Commands MCA Merge Plat
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15 - Script Commands Set Variable C
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15 - Script Commands RoMa Vector Co
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15 - Script Commands MCA96 Commands
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A - Appendix A Overview of the Log
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A - Appendix A Command Line Paramet
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A - Appendix A LogViewer Tool A.10.
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A - Appendix A Tecan Driver Install
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A - Appendix A Common Notification
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A - Appendix A Configuring and Usin
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D - Glossary Glossary of Terms and
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D - Glossary Important GUI features
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D - Glossary Important GUI features
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IX - Index IX Index Purpose of This
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IX - Index for the MCA96 . . . . .
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IX - Index LICOS (overview) . . . .
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IX - Index R Rack (overview) . . .
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IX - Index Te-Shake (overview) . .
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