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Invitrogen™ iBright™ SAE Software for 21 CFR Part 11, single license

Catalog No. A49208
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Catalog No. A49208 Supplier Invitrogen™ Supplier No. A49208

Please call Customer Service at 1-800-234-7437 or send an email to help@thermofisher.com for assistance.

For use with the iBright Imaging System and supports compliance with 21 CFR Part 11 FDA guidelines for security, auditing, and electronic (SAE) signatures using the SAE console.

  • Authentication of user login information
  • Ability to set password guidelines and expiry dates
  • Lockout access and re-authentication requirements after a period of inactivity
  • System lockout upon unauthorized attempts to access software
  • Ability of administrator to define user roles and permissions
  • Verification of each user's permissions to perform predefined activities
  • Identification of data tampering
  • Generation of audit trail log
  • Tracking of changes and committed actions to user roles, account management, and system settings
  • Ability of administrator to determine functions required to input reason for commit
  • Administrator determination of e-signature requirements
  • Ability to review records and sign electronically

Specifications

For Use With (Equipment) iBright Imaging System
Product Line iBright
Type Software License
Quantity 1 license
Software Type Software License
Are the iBright Imaging Systems network-compatible?

The iBright Imaging Systems support Ethernet network connections. WIFI is also supported with the addition of a USB-WIFI dongle. Data may be exported from the instrument via network and WIFI connections. It can also be exported via USB port.

For additional information on iBright functionality, visit this page.

Is a computer needed to control the iBright Imaging Systems?

iBright Imaging Systems feature a built-in computer interface controlled by the 12.1 inch touchscreen. No additional computer is needed to operate the instrument.

For additional information on iBright functionality, visit this page.

Do the iBright Imaging Systems support .tiff file export?

iBright imagers support the export of .tiff files in 8 and 16 bit formats. They also allow users to export images as .jpg and the proprietary .g2i file types. The iBright Analysis software primarily uses .g2i files as this format contains the most data to facilitate easy analysis. But it also supports .tiff files import and analysis.

For additional information on iBright functionality, visit this page.

Is analysis software included with purchase of an iBright Imaging System?

The free iBright Analysis Software (iBA) supports analysis of all images captured on iBright imagers and is available for free download on our website. There is also a Cloud version of iBA software available for users who prefer to work directly from a web browser.

The iBA software is supported on both Windows and Mac computers and can be used by any lab personnel who need it. This software automates data analysis and makes annotation, analysis, and reporting simple. To learn more about the iBA software, view the iBright Analysis Software how-to-videos available on this page.

To speak with a representative about the iBright imager or request a quote or demo, please fill out this form.

What are the primary differences between the iBright SAE secure version of the iBright Analysis software and the standard version of the software?

Most functionality is the same between the standard and secure versions of the iBright Analysis (iBA) software. The primary difference is that the secure version of the software supports the auditing and signature functionality that is needed to support 21CFR laboratories.

To learn more about iBA software, visit this page.

To speak with a representative about the iBright imager or request a quote or demo, please fill out this form.

What analysis software is compatible with iBright Imaging Systems?

iBright Analysis Software (iBA) is available for free download on our website. There is also a Cloud version of iBA software available for users who prefer to work directly from a web browser.

The iBA software is supported on both Windows and Mac computers and can be used by any lab personnel who need it. This software automates data analysis and makes annotation, analysis, and reporting simple. To learn more about the iBA software, view the iBright Analysis Software how-to-videos available on this page.

iBright imagers also support 16 bit .tiff export; this file type can be used with other second party software programs if desired.

To speak with a representative about the iBright imager or request a quote or demo, please fill out this form.

What are the main components of iBright SAE Software Solution for 21 CFR Part 11 Support on iBright Imaging Systems, that need to be installed, activated, and communicating with each other?

iBright SAE Software Solution for 21 CFR Part 11 Support on iBright Imaging Systems includes the following components that need to be installed, activated, and communicating:
- SAE Administrator Console Software: Used with the iBright Imager and Analysis Software Application Profile to configure the security, audit, and e-signature (SAE) settings for the iBright instrument and iBright Analysis Software
- iBright SAE License: Used to activate the SAE settings for the iBright instrument and iBright Analysis Software
- iBright instrument in SAE mode: Firmware that connects the iBright instrument to the SAE Administrator Console Software
- iBright Analysis Software: Secure desktop analysis software that connects with SAE Administrator Console Software settings for the iBright instrument and iBright Analysis Software