Thermo Fisher Scientific iBright User Manual

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Installation of the iBright SAE Software Solution for 21 CFR Part 11 Support
The Invitrogen
iBright™ SAE Software Solution for 21 CFR Part 11 Support includes the following components, which need to be to be installed, activated, and communicating with one another prior to use:
SAE Administrator Console Software—used with
the Invitrogen™ iBright™ Imager and Analysis Software Application Profile to configure the security, audit,
Invitrogen
mode that connectsthe instrument with the SAE Administrator Console Software
and e-signature settings for Invitrogen™ iBright™ ImagingSystems and analysis software
Invitrogen™ iBright™ Analysis Software—Secure—
desktop analysis software that connects with the SAE
Invitrogen™ iBright™ SAE License—used to activate
Administrator Console Software
the SAE settings for the iBright instrument and activate iBright Analysis Software—Secure
Where to access the appropriate downloads for setup:
Component Where to download Notes
SAE Administrator Console Software
iBright SAE License thermofisher.com/ibrightanalysis The request for an iBright SAE License only needs to be submitted
iBright Instrument— SAE mode
iBright Analysis Software—Secure
thermofisher.com/ibrightanalysis The SAE Administrator Console Software only needs to be
downloaded by the personnel that manage the security, audit, and e-signature procedures within the institution. The iBright Imager and Analysis Software Application Profile must be downloaded and imported into the SAE Administrator Console Software in order to configure settings specific to the iBright Imager and analysis software.
once for a given instrument. A license key will be returned to the contact provided on the webform. This license key can be used to unlock and activate SAE mode on the iBright Imaging System and to activate the iBright Analysis Software—Secure.
For the latest instrument firmware, go to thermofisher.com/
ibrightanalysis
thermofisher.com/ibrightanalysis End-users have the option of using either the on-instrument analysis
No separate downloads are necessary to activate SAE mode as long as the instrument is running firmware version 1.5.0 or above. Imaging systems with a firmware version of 1.5.0 and above will have SAE mode functionality built in. However, the SAE license key must be entered on the instrument to unlock and activate SAE mode.
software or the stand-alone iBright Analysis Software—Secure desktop software, but we recommend using the desktop software for an optimal experience. The iBright SAE License will unlock and activate the desktop software and must be entered by each end-user after downloading and installing the software.
iBright™ Instrument–SAE mode—firmware
For additional details on configuring your system once the downloads and installations are complete, refer to the following documents, according to the Invitrogen
iBright CL750 Imaging System User Guide
iBright CL750 Imaging System Quick Reference
iBright CL1500/FL1500 Imaging System User Guide
iBright™ instrument model you’reusing:
iBright CL1500/FL1500 Imaging System
Quick Reference
SAE Administrator User Guide For iBright Imaging Systems
Learn more at thermofisher.com/ibrightCFR
For Research Use Only. Not for use in diagnostic procedures. © 2017–2020 Thermo Fisher S cientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. COL112476 0820
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