Software Manual Freedom EVOware Standard 2.3 Freedom ...

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B - Appendix B - FDA 21 CFR Part 11 Compliance Part B - Electronic Records ⌦ Protection of data with checksums Compliance Freedom EVOware See B.5.4 “Checksums”, B-8. Compliance Tecan Customer No action required. B.7.1.3 § 11.10 (c) Protection of records ⌦ Data Archiving Processes and Procedures for Long-term Data Storage Compliance Freedom EVOware See B.5.8 “Backing Up Files”, B-11. Compliance Tecan Customer Tecan customers must develop and implement a procedure to store and archive the process data, the trace file (audit trail) and the log files created by Freedom EVOware and protect them against accidental or intentional modification, falsification or deletion. In some cases, the records must be kept for 10 years or longer. Due to the expected technical changes in hardware and software over such time spans, this requires consideration of issues such as the appropriate choice of storage media, file formats, etc. ⌦ Protection of directories used to store process data and log files to ensure that they are only accessible to authorized persons 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 The integrity and completeness of the electronic records relies on the customer’s assignment of Microsoft Windows access rights for the PC and the computer network and on data backup and archiving procedures. Tecan customers must set appropriate access privileges for the local and network files and directories to ensure that records can only be deleted or modified by authorized persons. ⌦ Access to process data and log files after a number of years Compliance Freedom EVOware No action required. B - 18 Freedom EVOware Software Manual, 393172, en, V2.3
B - Appendix B - FDA 21 CFR Part 11 Compliance Part B - Electronic Records Compliance Tecan Customer Tecan customers must establish rigorous and systematic archiving and backup procedures to ensure that electronic records generated by Freedom EVOware are stored in such a manner that they can be retrieved and used over an extended period of time. In some cases, the records must be kept for 10 years or longer. Due to the expected technical changes in hardware and software over such time spans, this requires consideration of issues such as the appropriate choice of storage media, file formats, etc. B.7.1.4 § 11.10 (d) Limiting System Access to Authorized Individuals ⌦ Microsoft operating system Compliance Freedom EVOware See B.5.1 “Closed Systems”, B-6. See B.5.3 “Tecan User Management System”, B-7. Compliance Tecan Customer Tecan customers must develop and implement user management procedures for their employees to control access to the Freedom EVOware software and the Microsoft operating system. The access control mechanisms should be designed to prevent unauthorized persons from gaining access to, altering or deleting records in the system or carrying out unauthorized functions within the system. Access security is typically ensured with a number of behavioral controls or policies that are backed up and enforced by appropriate security mechanisms implemented on the company’s information systems. Access control determines who is allowed to log on to a system locally or from the network. The Microsoft operating systems offers several different types of access privileges that can be granted or denied to specific users or groups of users. Under consideration of typical work practices in analytical laboratories, we recommend a system of access privileges on a task basis - not only to ensure confidentiality, but also to eliminate human mistakes or accidental loss of data. It is insufficient to only restrict system access to a group of individuals without differentiating their responsibilities, knowledge or position. In this case, users could inadvertently modify system settings in a way that affects the integrity or security of the records. ⌦ Different Levels of Access Based On User Responsibilities Compliance Freedom EVOware See B.5.2 “Freedom EVOware User Levels”, B-7. Compliance Tecan Customer See B.4.1 “Assigning and Using Freedom EVOware User Names”, B-6. Freedom EVOware Software Manual, 393172, en, V2.3 B - 19
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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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7 - Tecan User Management System Fr
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7 - Tecan User Management System Sp
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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 Dispense Comma
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15 - Script Commands Mix Command Lo
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15 - Script Commands Wash Tips Comm
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15 - Script Commands Periodic Wash
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15 - Script Commands Get DITIs Comm
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15 - Script Commands Set DITI Posit
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15 - Script Commands Pick Up DITIs
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15 - Script Commands Pickup ZipTip
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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 Te-Fill Dispen
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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 Copy Plate Wiz
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15 - Script Commands Replicates Wiz
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15 - Script Commands Serial Dilutio
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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 Move PnP Comma
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15 - Script Commands PosID Command
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15 - Script Commands Balance Comman
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15 - Script Commands Balance Send C
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15 - Script Commands MCA96 Commands
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15 - Script Commands MCA384 Command
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17 - Special Features, Example Scri
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18 - Error Handling Error Dialogs 1
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19 - Customer Support 19 Customer S
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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 ASTM Interface Modul
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A - Appendix A Configuring and Usin
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A - Appendix A Advanced Worklist Co
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IX - Index IX Index Purpose of This
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IX - Index D-18 Centrifuge (overvie
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IX - Index Notification . . . . . .
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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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