The Invitrogen iBright Imaging Systems balance powerful features and hardware in a package that is easy to use for researchers of all experience levels. Feel at home with our touchscreen interface carefully crafted to provide smooth image capture experience. Get publication quality data fast with a powerful 9.1MP camera and a suite of automated features. Streamline image analysis with built-in on-instrument software or our standalone iBright Analysis Software. Understand your data better with straightforward total lane protein and house-keeping protein normalization workflows. Read on to find the right iBright Imager for your needs.
1x1, 2x2, 3x3, 4x4, 5x5, 6x6, 8x8 (maximum flexibility for adjusting resolution and sensitivity based on needs)
Zoom
1–2x, digital (digital zoom reduces the effective resolution of the zoomed image)
1–8x (1–2x mechanical + 1–4x digital) (Mechanical zoom maximizes sensitivity by moving the camera closer to the sample stage, reducing focal length)
System interface
Touchscreen
12.1 inch capacitive LCD display, 1,024 x 768 pixels
Storage and connectivity
USB
2 USB (2.0)
Network
Ethernet port, Connect (cloud-based) connectivity, optional Wi-Fi (adapter sold separately)
Image file format
G2i (proprietary), TIFF, JPG, PNG
Hard drive
64 GB SSD
256 GB SSD
System Hardware
Sampler drawer
Manual operation
Automatic open/close with automatic sample rotation (up to 10°)
Filter set
2 filters (0 excitation, 2 emission)
4 filters (2 excitation, 2 emission)
12 filter (6 excitation, 6 emission)
Illumination source
Green LED (470–550 nm) transilluminator
Green LED (470–550 nm) transilluminator
Epi white LED
Green LED (470–550 nm) transilluminator
Epi white LED
Epi near-IR LED
System software
Automated featured
Automatic zoom
Automatic focus
Automatic exposure (Smart Exposure)
Automatic on-board image analysis
Stand-alone analysis applications
iBright Analysis Software: desktop version (macOS™ or Windows™ operating systems) and Connect (cloud-based) version
Shipping, warranty, and upgrades
Dimensions
(L x W x H): 68 x 38 x 60 cm
Weight
Approximately 47 kg (105 lb)
Approximately 50 kg (110 lbs)
Warranty
1 year from date of purchase
2 years from date of purchase
Upgradability
No
Yes, to FL1500 imager
No
* Membranes must be imaged when wet, using Thermo Scientific Pierce Reversible Protein Stain Kit for Nitrocellulose Membranes or Thermo Scientific Pierce Reversible Protein Stain Kit for PVDF Membranes. ** Applications provide a qualitative visualization of the object or confirmation of the presence of signal. Not recommended for quantitation.
The iBright 1500 Series Imaging Systems consist of two models: the iBright FL1500 Imaging System and the iBright CL1500 Imaging System. The iBright FL1500 Imaging System is our premier instrument, and supports the main imaging applications of fluorescent, chemiluminescent, and colorimetric western blots, in addition to fluorescent stained nucleic acid gels, fluorescent stained protein gels, colorimetric stained protein gels, and colorimetric membrane stains. We also offer the iBright CL1500 Imaging System, which features the same imaging capabilities as the iBright FL1500 Imaging System, but without fluorescent western blot imaging functionality.
Features of the iBright 1500 Series Imaging Systems:
9.1 MP cooled CCD camera: high sensitivity and dynamic range to help enable the detection of subtle differences in samples
Five fluorescence channels: multiplex and capture up to four proteins in a single blot for more meaningful and representative experiments (FL1500 model only)
Smart Exposure technology: provides rapid determination of optimal exposure time
Simple interface: clear layout of functions and features combined with a 12.1-inch capacitive touchscreen for a smooth imaging experience
Advanced automated features: automatic sample rotation, automatic zoom, and automatic focus help streamline image capture
22.5 x 18.0-cm field of view: large field of view for high-throughput imaging (image up to four mini or two midi blots at a time)
Green LED-based transilluminator: effectively excite popular DNA dyes such as ethidium bromide and Invitrogen SYBR Green dyes with an alternative to UV-based transilluminators
Flexible connectivity: export captured images via ethernet connection, Wi-Fi (with optional accessory), USB, or directly to Connect (cloud-based platform)
Multiple image analysis options: perform densitometry, quantitation, and normalization directly on iBright using the on-instrument software, or with our standalone iBright Analysis Software (available in both desktop and cloud-based versions)
iBright Imaging Systems
Capture images and analyze data from your western blots and gels efficiently and easily using the Invitrogen iBright Imaging Systems. With a blend of modern design and performance, enhance your imaging workflow today.
Capture high quality images fast with Invitrogen iBright Imaging Systems
Learn about the Invitrogen iBright Imaging Systems' Smart Exposure technology, and see how simple it is to capture an image.
Customize exposure routines easily with Invitrogen iBright Imaging Systems
Learn about the Invitrogen iBright Imaging Systems' signal accumulation, multi-exposure, and region-of-interest Smart Exposure features.
Analyze images quickly with Invitrogen iBright Imaging Systems
Analyze images directly on Invitrogen iBright Imaging Systems with a smooth on-board analysis workflow.
How to use Invitrogen No-Stain Protein Labeling Reagent and the iBright Imaging System for fast, easy, and accurate quantitative western blotting
This video demonstrates how fast and easy it is to use Invitrogen No-Stain Protein Labeling Reagent and the iBright Imaging System to capture and quantitate western blotting data using total protein normalization.
Scientist: Guillaume Pidoux Location: France Abstract: My group focuses on the spatiotemporal regulation of cAMP signaling in cardiac physiological and pathophysiological conditions.
The heart ensures that peripheral organs are perfused with blood and nutrients. Any alterations of this function lead to heart injury and failure. A-kinase anchoring proteins (AKAPs) are a family of scaffolding proteins that anchors protein kinase-A (PKA), and thus plays a central role in the regulation of cardiac function under physiological and pathological conditions.
We focus on understanding the direct role of AKAPs in cardiac physiology and during the occurrence of cardiomyopathies. We utilize molecular biology tools to direct shRNA mediated knockdown and reconstitution assays combined with biochemical assays (i.e., immunoblot, co-immunoprecipitation, TR-FRET and Alpha-Screen). We further support our studies with state-of-the-art confocal imaging (i.e., live-cell FRAP & FLIP, proximity ligation assay and super-resolution imaging).
Furthermore, we aim to develop protein-protein interactor (PPI) disrupting peptides to counteract anchored-PKA dependent cellular processes that are modified during cardiac pathologies. These specific PPIs could serve as new potential specific cardiac therapeutic agents.
Favorite feature of the iBright system: Easy-to-use interface allowing the acquisition of excellent resolution pictures.
What is 21 CFR Part 11 Compliance?
The FDA released the Electronic Records and Signatures Rule, known as 21 CFR Part 11 in August 1997. This rule defines the requirements for use of electronic documents in place of paper documents. The law specifies the system elements, controls, and procedures that are necessary to ensure the reliability of electronically stored records.
21 CFR part 11 compliance is composed of both procedural and technical requirements. Procedural requirements are the standard operating procedures instituted by the end user, and technical requirements are the functional characteristics of the compliance management software used. Satisfying the technical requirements does not guarantee 21 CFR part 11 compliance alone. Compliance is the consequence of the end user’s work process and systems used.
For technical details on how the Invitrogen iBright SAE Software Solution for 21 CFR Part 11 Support helps enable workflows compliant to 21 CFR part 11, review the technical specifications document.
What is the iBright SAE Software Solution for 21 CFR Part 11 Support?
To implement the iBright SAE Software Solution for 21 CFR Part 11 support on iBright Imaging Systems, you need the following components installed, activated, and communicating with each other (Figure 1):
SAE Administrator ConsoleSoftware: used with the iBright Imager and Analysis Application Profile to configure the security, audit and e-signature settings for iBright Imaging Systems
iBright SAE License: used to activate the SAE settings for the iBright instrument and the iBright Analysis Software—Secure desktop software
iBright Instrument—SAE Mode: firmware mode that connects the instrument to the SAE Administrator Console
iBright Analysis Software—Secure: desktop analysis software that connects with the SAE Administrator Console
Click image to enlarge
Figure 1. iBright 21CFR11 Software Solution* comprised of (1) Security, Audit and e-signature (SAE) Software (SAE Admin Console, SAE Server, and SAE Application Profile (i.e. iBright Imager and Analysis Software)), (2a) iBright Instrument – SAE Mode (onboard software), (3) iBright Analysis Software—Secure (desktop analysis software). *iBright SAE Software License is required for activation of the 21 CFR Part 11 support package.
SAE Administrator Console
The SAE Administrator Console is the tool used to configure security, audit, and e-signature settings to meet user-specific requirements for security, audit, and e-signature of a particular instrument and/or analysis software. The instrument and/or analysis software is called an application profile (e.g. iBright Imager and Analysis Software application profile) and must be installed in the SAE Administrator Console before the SAE settings can be used on the instrument of analysis software (Figure 2). Once the application is installed in the SAE Administrator Console, an SAE server is used to connect to the instrument and or analysis software to the SAE Administrator Console. This SAE server is located on a network computer.
Click image to enlarge
Figure 2. Interface view from the SAE Administrator Console.
iBright SAE License
iBright SAE Software License for 21 CFR Part 11 is for use with the iBright Imaging System and supports compliance with 21 CFR Part 11 FDA guidelines for security, auditing, and e-signatures (SAE) using the SAE console. The SAE Software License is required to activate SAE Mode on the iBright Imaging System and to activate the iBright Analysis Software—Secure desktop analysis software.
iBright Imaging System SAE Mode
The Bright capitalize imaging system firmware allows 21CFR Part 11 support through activation of the SAE Mode setting. When SAE Mode is activated, the iBright instrument connects to the SAE Administrator Console via the SAE server. Security, Audit and e-signature settings, as defined in the SAE Administrator Console, are implemented on the iBright instrument (Figure 3). Features include restriction of unauthorized users to the system, password policies and expiration dates, defined user permissions and roles, tracking of all data changes through audit log, available audit reports, and on-board e-signature workflows. All iBright imaging systems can run in SAE Mode through purchase of the iBright SAE Software License.
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Figure 3. Visuals from the iBright Imaging System interface showing how to access SAE Mode.
iBright Analysis Software—Secure
The iBright Analysis Software—Secure is a separate version of our iBright Analysis Software platform to support compliance with 21 CFR Part 11 FDA guidelines for Security, Auditing, and Electronic Signatures when connected to the SAE Administrator Console via the SAE server. The iBright Analysis Software—Secure desktop software can be utilized on computers running Windows or Mac operating systems, and can be configured to:
Control access to data using account credentials
Track user actions through audit logs
Detect data tampering
Sign electronic documents using electronic signatures
How does the iBright SAE Software Solution for 21 CFR Part 11 Support work?
Functional characteristics of the Invitrogen iBright SAE Software Solution for 21 CFR Part 11 Support
Function
Description
System security
Controls user access to an application by allowing creation of user account and defining user privileges through roles and defining password policies
Auditing
Tracks actions performed by users, changes to the SAE module settings, and creating audit reports.
Electronic signature (e-signature)
Determines if users are required to fulfill signature requirements before performing specific functions.
Additional design features for each function are detailed below:
Security
Access is restricted to authorized personnel via user ID and password (Figure 4).
Click image to enlarge
Figure 4. Interface of the SAE Administrator Console showing new user account creation.
Passwords and user ID must expire after a user-defined number of days (typically 90 days).
Automatic logout after user-defined minutes of inactivity (Figure 5).
Click image to enlarge
Figure 5. Interface of the SAE Administrator Console showing user name and password policy settings.
ID and password must be re-entered to sign or modify record.
Must have a method to record and automatically report ‘forgery’ attempts (event notification).
Access and manipulation of various software functions are controlled through user role definitions.
Control access to specific areas and options in software (Figure 6).
Click image to enlarge
Figure 6. Interface of the SAE Administrator Console showing user role settings.
Auditing
Tracks actions performed by users and changes to the SAE settings. The SAE Administrator Console automatically tracks auditable actions silently (including, but not limited to, sign in/sign out, image acquisition, image exported, image deleted, file signed and report generation) (Figure 7).
Click image to enlarge
Figure 7. Interface of SAE Administrator Console showing the audit history tab. (1) audit history available (action records, system configuration records, application object records), (2) application (SAE, iBright Instrument and Analysis Software, or other), (3) action, (4) date and user name (5) export in readable/printable format (PDF or .txt), (6) object ID.
With the auditing functionality, you can:
Select to audit specific user actions and specify the audit mode (silent, optional or required)
Generate reports for audited user actions and SAE module changes
Generate reports for software or instrument actions and events
Electronic signature
Determines if users are required to fulfill signature requirements before performing specific functions (Figure 8).
Click image to enlarge
Figure 8. Interface of the SAE Administrator Console e-signature settings. (1) customize the meanings of e-signatures (2) customize the number of e-signatures required by meaning and role (3) type of data signed for a specific selected meaning.
With the electronic signature functionality, you can:
Configure each e-signature event to require users with specific roles to sign
Create separate meanings with customized signature requirements for each meaning
Committing auditable actions
Auditable actions can be committed onboard the iBright Imaging Systems instrument or in the iBright Analysis Software—Secure software. In order to track changes, changes must be committed and saved. The committed changes made can be viewed under audit tab in the software application. Every commit creates a new version of metadata and is logged in the audit summary table in the audit tab. All committed actions are sent to SAE and logged under audit action records.
In the Commit workflow, select the Reason to commit from the selections displayed (or choose Other/Custom Reason). Enter comments as required and click on Commit (Figures 9 and 10).
Click image to enlarge
Figure 9. iBright Analysis Software—Secure desktop software showing the reason to commit window and function (1) reason field (2) option to add a custom reason (3) comments.
Click image to enlarge
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Figure 10. iBright Imager SAE Mode auditable changes screens, displaying reason to commit window and function (1) reason field, touch “Blank reason” box to open audit reason screen (2) Select from options or “Other” to add a custom reason (3) enter comments if needed and touch Save, (4) confirmation screen of changes committed.
Signing files and generating signed reports
When all the changes are done and committed, the file can be signed as per signature rules set in the SAE Administrator Console. Signature requirements (number of signatures and role required) for the selected meaning will be listed in the table (Figures 11a and 11b). Once all signatures are obtained, the status of the signature rule will be updated in the e-signature table for the corresponding version found in the audit tab from unsigned to signed. A signature log will be added in e-signature summary table.
In e-signature workflow, select the applicable e-signature meaning. Required signatures and roles will be listed. Select the applicable role and enter credentials. When all signatures are obtained, the file will be fully signed and locked.
Note: iBright Analysis Software–Secure allows partially signed files to be shared across user computers in partially signed state. When all signatures are obtained, the file will lock. iBright Instrument e-signature workflows requires all signatures to be obtained before existing the e-signature workflow.
A
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B
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Figure 11: Signature workflow in iBright Analysis Software—Secure (panel A) and iBright Imager SAE Mode (panel B). Select Signature Meaning from available drop down. In iBright Analysis Software—Secure, each required role is listed, and signatures can be provided by clicking on “unsigned” status link for designated role. Partially signed files can be sent to additional users using iBright Analysis Software—Secure to complete all signature requirements. In iBright Imager SAE Mode, signature requirements for the designated Meaning are listed under the user icons. All signatures must be obtained at the same time onboard the iBright.
A report can be created directly from the iBright Imaging Systems instrument or from the iBright Analysis Software—Secure desktop software as either unsigned or signed. The file must be fully signed by all required roles/signatures prior to generating a signed report (Figure 12).
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Figure 12. Export of image analysis report from iBright Analysis Software—Secure desktop software.
How do I set up the iBright SAE Software Solution for 21 CFR Part 11 Support?
Have you purchased the iBright SAE Software Solution for 21 CFR Part 11 support? Setting up the package is simple. Please refer to the iBright SAE Software Solution or 21 CFR Part 11 Support - Welcome Letter and the following quick start guides and user guides for more information:
1x1, 2x2, 3x3, 4x4, 5x5, 6x6, 8x8 (maximum flexibility for adjusting resolution and sensitivity based on needs)
Zoom
1–2x, digital (digital zoom reduces the effective resolution of the zoomed image)
1–8x (1–2x mechanical + 1–4x digital) (Mechanical zoom maximizes sensitivity by moving the camera closer to the sample stage, reducing focal length)
System interface
Touchscreen
12.1 inch capacitive LCD display, 1,024 x 768 pixels
Storage and connectivity
USB
2 USB (2.0)
Network
Ethernet port, Connect (cloud-based) connectivity, optional Wi-Fi (adapter sold separately)
Image file format
G2i (proprietary), TIFF, JPG, PNG
Hard drive
64 GB SSD
256 GB SSD
System Hardware
Sampler drawer
Manual operation
Automatic open/close with automatic sample rotation (up to 10°)
Filter set
2 filters (0 excitation, 2 emission)
4 filters (2 excitation, 2 emission)
12 filter (6 excitation, 6 emission)
Illumination source
Green LED (470–550 nm) transilluminator
Green LED (470–550 nm) transilluminator
Epi white LED
Green LED (470–550 nm) transilluminator
Epi white LED
Epi near-IR LED
System software
Automated featured
Automatic zoom
Automatic focus
Automatic exposure (Smart Exposure)
Automatic on-board image analysis
Stand-alone analysis applications
iBright Analysis Software: desktop version (macOS™ or Windows™ operating systems) and Connect (cloud-based) version
Shipping, warranty, and upgrades
Dimensions
(L x W x H): 68 x 38 x 60 cm
Weight
Approximately 47 kg (105 lb)
Approximately 50 kg (110 lbs)
Warranty
1 year from date of purchase
2 years from date of purchase
Upgradability
No
Yes, to FL1500 imager
No
* Membranes must be imaged when wet, using Thermo Scientific Pierce Reversible Protein Stain Kit for Nitrocellulose Membranes or Thermo Scientific Pierce Reversible Protein Stain Kit for PVDF Membranes. ** Applications provide a qualitative visualization of the object or confirmation of the presence of signal. Not recommended for quantitation.
The iBright 1500 Series Imaging Systems consist of two models: the iBright FL1500 Imaging System and the iBright CL1500 Imaging System. The iBright FL1500 Imaging System is our premier instrument, and supports the main imaging applications of fluorescent, chemiluminescent, and colorimetric western blots, in addition to fluorescent stained nucleic acid gels, fluorescent stained protein gels, colorimetric stained protein gels, and colorimetric membrane stains. We also offer the iBright CL1500 Imaging System, which features the same imaging capabilities as the iBright FL1500 Imaging System, but without fluorescent western blot imaging functionality.
Features of the iBright 1500 Series Imaging Systems:
9.1 MP cooled CCD camera: high sensitivity and dynamic range to help enable the detection of subtle differences in samples
Five fluorescence channels: multiplex and capture up to four proteins in a single blot for more meaningful and representative experiments (FL1500 model only)
Smart Exposure technology: provides rapid determination of optimal exposure time
Simple interface: clear layout of functions and features combined with a 12.1-inch capacitive touchscreen for a smooth imaging experience
Advanced automated features: automatic sample rotation, automatic zoom, and automatic focus help streamline image capture
22.5 x 18.0-cm field of view: large field of view for high-throughput imaging (image up to four mini or two midi blots at a time)
Green LED-based transilluminator: effectively excite popular DNA dyes such as ethidium bromide and Invitrogen SYBR Green dyes with an alternative to UV-based transilluminators
Flexible connectivity: export captured images via ethernet connection, Wi-Fi (with optional accessory), USB, or directly to Connect (cloud-based platform)
Multiple image analysis options: perform densitometry, quantitation, and normalization directly on iBright using the on-instrument software, or with our standalone iBright Analysis Software (available in both desktop and cloud-based versions)
Capture images and analyze data from your western blots and gels efficiently and easily using the Invitrogen iBright Imaging Systems. With a blend of modern design and performance, enhance your imaging workflow today.
Capture high quality images fast with Invitrogen iBright Imaging Systems
Learn about the Invitrogen iBright Imaging Systems' Smart Exposure technology, and see how simple it is to capture an image.
Customize exposure routines easily with Invitrogen iBright Imaging Systems
Learn about the Invitrogen iBright Imaging Systems' signal accumulation, multi-exposure, and region-of-interest Smart Exposure features.
Analyze images quickly with Invitrogen iBright Imaging Systems
Analyze images directly on Invitrogen iBright Imaging Systems with a smooth on-board analysis workflow.
How to use Invitrogen No-Stain Protein Labeling Reagent and the iBright Imaging System for fast, easy, and accurate quantitative western blotting
This video demonstrates how fast and easy it is to use Invitrogen No-Stain Protein Labeling Reagent and the iBright Imaging System to capture and quantitate western blotting data using total protein normalization.
Scientist: Guillaume Pidoux Location: France Abstract: My group focuses on the spatiotemporal regulation of cAMP signaling in cardiac physiological and pathophysiological conditions.
The heart ensures that peripheral organs are perfused with blood and nutrients. Any alterations of this function lead to heart injury and failure. A-kinase anchoring proteins (AKAPs) are a family of scaffolding proteins that anchors protein kinase-A (PKA), and thus plays a central role in the regulation of cardiac function under physiological and pathological conditions.
We focus on understanding the direct role of AKAPs in cardiac physiology and during the occurrence of cardiomyopathies. We utilize molecular biology tools to direct shRNA mediated knockdown and reconstitution assays combined with biochemical assays (i.e., immunoblot, co-immunoprecipitation, TR-FRET and Alpha-Screen). We further support our studies with state-of-the-art confocal imaging (i.e., live-cell FRAP & FLIP, proximity ligation assay and super-resolution imaging).
Furthermore, we aim to develop protein-protein interactor (PPI) disrupting peptides to counteract anchored-PKA dependent cellular processes that are modified during cardiac pathologies. These specific PPIs could serve as new potential specific cardiac therapeutic agents.
Favorite feature of the iBright system: Easy-to-use interface allowing the acquisition of excellent resolution pictures.
The FDA released the Electronic Records and Signatures Rule, known as 21 CFR Part 11 in August 1997. This rule defines the requirements for use of electronic documents in place of paper documents. The law specifies the system elements, controls, and procedures that are necessary to ensure the reliability of electronically stored records.
21 CFR part 11 compliance is composed of both procedural and technical requirements. Procedural requirements are the standard operating procedures instituted by the end user, and technical requirements are the functional characteristics of the compliance management software used. Satisfying the technical requirements does not guarantee 21 CFR part 11 compliance alone. Compliance is the consequence of the end user’s work process and systems used.
For technical details on how the Invitrogen iBright SAE Software Solution for 21 CFR Part 11 Support helps enable workflows compliant to 21 CFR part 11, review the technical specifications document.
What is the iBright SAE Software Solution for 21 CFR Part 11 Support?
To implement the iBright SAE Software Solution for 21 CFR Part 11 support on iBright Imaging Systems, you need the following components installed, activated, and communicating with each other (Figure 1):
SAE Administrator ConsoleSoftware: used with the iBright Imager and Analysis Application Profile to configure the security, audit and e-signature settings for iBright Imaging Systems
iBright SAE License: used to activate the SAE settings for the iBright instrument and the iBright Analysis Software—Secure desktop software
iBright Instrument—SAE Mode: firmware mode that connects the instrument to the SAE Administrator Console
iBright Analysis Software—Secure: desktop analysis software that connects with the SAE Administrator Console
Click image to enlarge
Figure 1. iBright 21CFR11 Software Solution* comprised of (1) Security, Audit and e-signature (SAE) Software (SAE Admin Console, SAE Server, and SAE Application Profile (i.e. iBright Imager and Analysis Software)), (2a) iBright Instrument – SAE Mode (onboard software), (3) iBright Analysis Software—Secure (desktop analysis software). *iBright SAE Software License is required for activation of the 21 CFR Part 11 support package.
SAE Administrator Console
The SAE Administrator Console is the tool used to configure security, audit, and e-signature settings to meet user-specific requirements for security, audit, and e-signature of a particular instrument and/or analysis software. The instrument and/or analysis software is called an application profile (e.g. iBright Imager and Analysis Software application profile) and must be installed in the SAE Administrator Console before the SAE settings can be used on the instrument of analysis software (Figure 2). Once the application is installed in the SAE Administrator Console, an SAE server is used to connect to the instrument and or analysis software to the SAE Administrator Console. This SAE server is located on a network computer.
Click image to enlarge
Figure 2. Interface view from the SAE Administrator Console.
iBright SAE License
iBright SAE Software License for 21 CFR Part 11 is for use with the iBright Imaging System and supports compliance with 21 CFR Part 11 FDA guidelines for security, auditing, and e-signatures (SAE) using the SAE console. The SAE Software License is required to activate SAE Mode on the iBright Imaging System and to activate the iBright Analysis Software—Secure desktop analysis software.
iBright Imaging System SAE Mode
The Bright capitalize imaging system firmware allows 21CFR Part 11 support through activation of the SAE Mode setting. When SAE Mode is activated, the iBright instrument connects to the SAE Administrator Console via the SAE server. Security, Audit and e-signature settings, as defined in the SAE Administrator Console, are implemented on the iBright instrument (Figure 3). Features include restriction of unauthorized users to the system, password policies and expiration dates, defined user permissions and roles, tracking of all data changes through audit log, available audit reports, and on-board e-signature workflows. All iBright imaging systems can run in SAE Mode through purchase of the iBright SAE Software License.
Click image to enlarge
Click image to enlarge
Click image to enlarge
Figure 3. Visuals from the iBright Imaging System interface showing how to access SAE Mode.
iBright Analysis Software—Secure
The iBright Analysis Software—Secure is a separate version of our iBright Analysis Software platform to support compliance with 21 CFR Part 11 FDA guidelines for Security, Auditing, and Electronic Signatures when connected to the SAE Administrator Console via the SAE server. The iBright Analysis Software—Secure desktop software can be utilized on computers running Windows or Mac operating systems, and can be configured to:
Control access to data using account credentials
Track user actions through audit logs
Detect data tampering
Sign electronic documents using electronic signatures
How does the iBright SAE Software Solution for 21 CFR Part 11 Support work?
Functional characteristics of the Invitrogen iBright SAE Software Solution for 21 CFR Part 11 Support
Function
Description
System security
Controls user access to an application by allowing creation of user account and defining user privileges through roles and defining password policies
Auditing
Tracks actions performed by users, changes to the SAE module settings, and creating audit reports.
Electronic signature (e-signature)
Determines if users are required to fulfill signature requirements before performing specific functions.
Additional design features for each function are detailed below:
Security
Access is restricted to authorized personnel via user ID and password (Figure 4).
Click image to enlarge
Figure 4. Interface of the SAE Administrator Console showing new user account creation.
Passwords and user ID must expire after a user-defined number of days (typically 90 days).
Automatic logout after user-defined minutes of inactivity (Figure 5).
Click image to enlarge
Figure 5. Interface of the SAE Administrator Console showing user name and password policy settings.
ID and password must be re-entered to sign or modify record.
Must have a method to record and automatically report ‘forgery’ attempts (event notification).
Access and manipulation of various software functions are controlled through user role definitions.
Control access to specific areas and options in software (Figure 6).
Click image to enlarge
Figure 6. Interface of the SAE Administrator Console showing user role settings.
Auditing
Tracks actions performed by users and changes to the SAE settings. The SAE Administrator Console automatically tracks auditable actions silently (including, but not limited to, sign in/sign out, image acquisition, image exported, image deleted, file signed and report generation) (Figure 7).
Click image to enlarge
Figure 7. Interface of SAE Administrator Console showing the audit history tab. (1) audit history available (action records, system configuration records, application object records), (2) application (SAE, iBright Instrument and Analysis Software, or other), (3) action, (4) date and user name (5) export in readable/printable format (PDF or .txt), (6) object ID.
With the auditing functionality, you can:
Select to audit specific user actions and specify the audit mode (silent, optional or required)
Generate reports for audited user actions and SAE module changes
Generate reports for software or instrument actions and events
Electronic signature
Determines if users are required to fulfill signature requirements before performing specific functions (Figure 8).
Click image to enlarge
Figure 8. Interface of the SAE Administrator Console e-signature settings. (1) customize the meanings of e-signatures (2) customize the number of e-signatures required by meaning and role (3) type of data signed for a specific selected meaning.
With the electronic signature functionality, you can:
Configure each e-signature event to require users with specific roles to sign
Create separate meanings with customized signature requirements for each meaning
Committing auditable actions
Auditable actions can be committed onboard the iBright Imaging Systems instrument or in the iBright Analysis Software—Secure software. In order to track changes, changes must be committed and saved. The committed changes made can be viewed under audit tab in the software application. Every commit creates a new version of metadata and is logged in the audit summary table in the audit tab. All committed actions are sent to SAE and logged under audit action records.
In the Commit workflow, select the Reason to commit from the selections displayed (or choose Other/Custom Reason). Enter comments as required and click on Commit (Figures 9 and 10).
Click image to enlarge
Figure 9. iBright Analysis Software—Secure desktop software showing the reason to commit window and function (1) reason field (2) option to add a custom reason (3) comments.
Click image to enlarge
Click image to enlarge
Click image to enlarge
Click image to enlarge
Figure 10. iBright Imager SAE Mode auditable changes screens, displaying reason to commit window and function (1) reason field, touch “Blank reason” box to open audit reason screen (2) Select from options or “Other” to add a custom reason (3) enter comments if needed and touch Save, (4) confirmation screen of changes committed.
Signing files and generating signed reports
When all the changes are done and committed, the file can be signed as per signature rules set in the SAE Administrator Console. Signature requirements (number of signatures and role required) for the selected meaning will be listed in the table (Figures 11a and 11b). Once all signatures are obtained, the status of the signature rule will be updated in the e-signature table for the corresponding version found in the audit tab from unsigned to signed. A signature log will be added in e-signature summary table.
In e-signature workflow, select the applicable e-signature meaning. Required signatures and roles will be listed. Select the applicable role and enter credentials. When all signatures are obtained, the file will be fully signed and locked.
Note: iBright Analysis Software–Secure allows partially signed files to be shared across user computers in partially signed state. When all signatures are obtained, the file will lock. iBright Instrument e-signature workflows requires all signatures to be obtained before existing the e-signature workflow.
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Figure 11: Signature workflow in iBright Analysis Software—Secure (panel A) and iBright Imager SAE Mode (panel B). Select Signature Meaning from available drop down. In iBright Analysis Software—Secure, each required role is listed, and signatures can be provided by clicking on “unsigned” status link for designated role. Partially signed files can be sent to additional users using iBright Analysis Software—Secure to complete all signature requirements. In iBright Imager SAE Mode, signature requirements for the designated Meaning are listed under the user icons. All signatures must be obtained at the same time onboard the iBright.
A report can be created directly from the iBright Imaging Systems instrument or from the iBright Analysis Software—Secure desktop software as either unsigned or signed. The file must be fully signed by all required roles/signatures prior to generating a signed report (Figure 12).
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Click image to enlarge
Figure 12. Export of image analysis report from iBright Analysis Software—Secure desktop software.
How do I set up the iBright SAE Software Solution for 21 CFR Part 11 Support?
Have you purchased the iBright SAE Software Solution for 21 CFR Part 11 support? Setting up the package is simple. Please refer to the iBright SAE Software Solution or 21 CFR Part 11 Support - Welcome Letter and the following quick start guides and user guides for more information:
