Front view of Countess 3 Automated Cell Counter

Thermo Fisher Scientific offers two high-performance cell counters designed to meet the needs of any lab. The Invitrogen Countess 3 and Countess 3 FL Automated Cell Counters utilize artificial intelligence, applying a deep-learning neural network algorithm to generate highly accurate cell counts even for challenging cell sample types. The machine-learning algorithm was taught by expert cell biologists to enable accurate and precise cell counting, avoiding user variation associated with manual hemocytometer cell counting.

Designed for convenience and time savings, the Countess 3 Automated Cell Counters come with more automated features like auto-lighting, autofocus, and autosave.

  • Accuracy—a highly accurate machine-learning algorithm is applied to cell counting.
  • Precision—auto-lighting and autofocus minimize user inputs and variability.
  • Speed—Rapid capture and autosave features generate and save results faster.
  • Convenient—built-in pre-dilution and cell splitting calculators, histograms and gating, and a results PDF report.
  • Affordable—both Countess 3 models are compatible with the Countess Reusable Slide.

3D Virtual Tour — Countess 3 and 3 FL Automated Cell Counters

Countess 3 and 3 FL Automated Cell Counter

Get acquainted with the Countess 3 and 3 FL Automated Cell Counters using this 3D virtual tour to experience how easy it is to use, with the interactive screen taking you step-by-step through the processes, including cell counts, calculators, histograms, and gating using different cells sample types.

View virtual tour

Machine-learning algorithm generates accurate counts; autofocus and auto-lighting minimize user-to-user variability

The Countess 3 Automated Cell Counters utilize machine-learning algorithms for fast and accurate focus determination as well as cell and viability counts. Countess instruments are compatible with a broad range of cell types and have been verified for use with several commonly used cell lines and primary cell types. Upon insertion of the slide, the Countess instrument will automatically provide optimized illumination and focus on the cells, which helps to minimize user variation associated with manual focusing and lighting adjustments. Cells ranging in size between ~4 µm and 60 µm and in cell suspension density ranging from 1 x 104 to 1 x 107 cells/mL are optimal for counting.

Bar graph of cell counts of different cell types counted by Attune NxT Flow Cytometer, Countess 3 Automated Cell Counter, and manually with a hemocytometer

Figure 1. Machine-learning algorithms result in highly accurate cell counts, comparable with flow cytometer counts. CHO-K1, HeLa, HEK293, Jurkat, and human PBMCs were counted using the Attune NxT Flow Cytometer (red bar), a Countess 3 FL Automated Cell Counter (blue bar), and manual counting using a hemocytometer and microscope (green bar). The Countess 3 FL Automated Cell Counter and hemocytometer bars represent an average of 6 counts. Error bars indicate standard deviation from 6 independent counts.

Scatter dot graph of cell counts of different cell types counted by Countess 3 Automated Cell Counter, and manually with a hemocytometer

Figure 2. Machine-learning algorithms result in highly precise cell counts with lower variability between counts compared to manual counting. CHO-K1, HeLa, HEK293, Jurkat, and human PBMCs were counted using the Countess 3 FL Automated Cell Counter (blue dots) and manual counting using a hemocytometer and microscope (green dots). The lines represent the median count and the dots demonstrate variance from 6 individual counts.

Bar graph of cell counts of human and mouse PBMCs by Countess 3 Automated Cell Counter and manually with a hemocytometer

Figure 3. Machine-learning algorithms result in highly accurate cell counts with challenging cell types and with more precision than manual counting. Human and mouse PBMCs were counted using the Countess 3 FL Automated Cell Counter (blue bar) and the manual counting method using a hemocytometer and microscope (green bar). The Countess 3 FL Automated Cell Counter and hemocytometer bars represent 6 counts. The error bars represent standard deviation.

Cell clumps counted accurately; debris ignored without gating inputs

Countess 3 Automated Cell Counters are able to accurately count cells that clump together. Whether you currently use automated or manual cell counting methods, obtaining accurate cell counts from samples containing clumpy cells can be difficult. Samples that contain debris add further complexity to cell counting. The Countess 3 Automated Cell Counter automatically excludes debris from cell counts. The machine-learning algorithm of the Countess Automated Cell Counter can clearly identify cell boundaries within clumps of cells and ignores debris, resulting in highly accurate cell counts (Figure 4).

Figure 4. Machine-learning algorithms generate accurate counts with clumpy cells and sample debris. The Countess 3 FL Automated Cell Counter was used to count RAW cells, which are both small and have a propensity to clump. The counting algorithm can resolve the cells in the clump and properly segment and count the cells. Debris is properly omitted from counts.

Small cells accurately counted

Rodent PBMCs are small cells around 5-7 microns and can be challenging to count whether manually on a hemocytometer or on an automated cell counter. The Countess 3 Automated Cell Counter’s machine-learning algorithm is robust and accurately counts these cells in both brightfield and fluorescence modes (Figure 5).

Figure 5. Rodent PBMCs accurately counted with machine-learning algorithm. The Countess 3 FL Automated Cell Counter was used to count small rodent PBMCs. Counts were performed with brightfield lighting (A) and with fluorescence lighting (B).

Streamlined process

There is always an abundance of work awaiting scientists in the lab. The Countess 3 Automated Cell Counter streamlines the process of cell counting. There are several tedious steps it takes to work through the manual cell counting process. The Countess 3 Automated Cell Counter eliminates many of those steps and the hands-on time to perform those steps (Figure 6). This additional time can be applied to other activities in the lab, resulting in a significant advantage when switching from manual to automated cell counting.

Comparison of cell counting processes

Rapid capture

Using the brightfield mode, once the slide is inserted, there is nothing further to do. The Countess 3 counter will automatically illuminate, auto-focus, and auto-count. This saves time with additional menu selections, getting you quickly to the results.

Home screen with Rapid capture enabled

Autosave

By selecting the autosave feature, cell counts and data are automatically saved. Couple this with the Rapid capture mode and the cell counting and data retention process becomes fully automated.

Save Options Screen shows various files that can be saved, data destinations, and editable field for sample name along with field for enabling autosave

Countess Cell Counting Chamber Slides

The disposable slides are convenient for quickly processing cell samples when there are many to process. There is no need to clean the reusable slide and wait for it to dry between cell samples.

Pipet is loading sample into chamber slide

Built-in pre-dilution and cell splitting calculators make any necessary calculations seamless and integrated into the cell counting process. Viewing histograms and any additional desired gating of cell counts are easy to do on the Countess 3 cell counter, and a printable PDF report of your results can be saved and printed.

Pre-dilution calculator

If the cell sample is concentrated and a dilution is required prior to cell counting, the Countess 3 cell counter can quickly and easily calculate the sample concentration. The Countess 3 cell counters can easily calculate or remove calculation of a 1:1 dilution with trypan blue.

Fields to input sample volume, buffer volume and a field to select if concentration should account for 1 to 1 trypan blue dilution

Cell splitting calculator

Easily determine the amount of cell sample and buffer needed for your experiment with the built-in cell splitting calculator. The cell count results are automatically used in the calculation; simply input the desired concentration and the volume needed.

Fields to choose Live or Total cells, desired concentration, and volume needed. At the bottom third of the screen, the Countess 3 instrument informs how much cell solution should be mixed with how much buffer

Easily gate cells and view histograms

Cells can be gated based on cell size, brightness, and circularity to fine-tune what is included or excluded for specific applications. View the histogram by selecting the graph icon and watch the changes in real time as you use the gating features. Using brightfield, the average cell size is aligned on the x-axis. Using fluorescence, the relative fluorescence units (RFU) is aligned on the x-axis.

Histogram of cells detected by GFP fluorescence and the low intensity cells are gated out

Printable report with cell counting results

Using a USB drive or Wi-Fi to establish cloud connectivity on the Countess 3 and 3 FL Automated Cell Counters, you can save your cell count results and images and then transfer them to your own computer. Image files can be saved as TIFF, PNG, or JPEG files, and the results are saved as a CSV file. A printable PDF report with results, images, and settings used can also be saved.

Report file includes summary of cell count concentration results in the different fluorescent channels, the intensity, histograms, and captured cell images

Responsive touchscreen and intuitive interface

The Countess 3 Automated Cell Counter’s screen selections are intuitive and easy to navigate. The LCD screen is a responsive touchscreen, not requiring an external computer. Its 1280 x 800 resolution provides high-quality cell images. The cell images can be supplemented with aids for identifying live/dead counts and, in the Countess 3 FL Automated Cell Counter, the ability to visualize fluorescence. The display is flush across the instrument, making it easy to keep clean. While the touchscreen is increasingly popular, the Countess 3 cell counter can accommodate use with a mouse connected with the USB port in the back of the instrument.

Photo taken from above the Countess 3 cell counter with a good view of the touchscreen

Wi-Fi enabled cloud connection

The Countess 3 Automated Cell Counter can save files directly to the Thermo Fisher Connect cloud-based platform service. By connecting to a local Wi-Fi network with the Wi-Fi dongle, files can be saved to the cloud. Access these files now or later, inside the lab or out – data that is available when and where you need it.

Access your Countess 3 data from anywhere with Wi-Fi cloud connectivity

What is 21 CFR part 11 compliance?

In August of 1997, the U.S. Food and Drug Administration (FDA) released the Electronic Records and Signatures Rule. This is known as 21 CFR Part 11 as it is Part 11 of Title 21 from the Code of Federal Regulations. 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 established by the end user’s institution
  • 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 both the institution’s work process and systems used.


Countess SAE Software Solution for 21 CFR Part 11 Compliance Support

To implement the Countess SAE Software Solution to support the technical 21 CFR Part 11 compliance portion on the Countess 3 and Countess 3 FL Automated Cell Counters, the following components need to be installed, activated, and communicating with each other.

The Countess SAE Software Solution for 21 CFR Part 11 Compliance Support consists of (Figure 1):

  1. SAE Software—used to configure the Security, Audit and Electronic-signature settings for Countess Automated Cell Counter. SAE software consists of the SAE Administrator Console (installed on a server with a static IP address) and SAE Application Profile.
  2. SAE License—Used to activate the SAE settings for the Countess Automated Cell Counter
  3. SAE Mode—Countess Automated Cell Counter software that is remotely connected with the SAE Administrator Console
Icons depicting the 3 components and how they are connected to one another.

Figure 1. The Countess SAE Software Solution for 21 CFR
Part 11 Compliance Support consists of (1) Security, Audit, and e-signature (SAE) software (the SAE Admin Console and the Countess SAE Application Profile software), (2) the SAE License needed to activate the SAE settings for the instrument, and (3) Countess SAE Mode (onboard software).

SAE Software—SAE Administrator Console

The SAE Administrator Console is a component of the Countess SAE Software Solution for 21 CFR Part 11 Compliance Support that allows configuration of the Countess instrument to meet user-specific requirements. The Countess Application Profile is another component that must be installed in the SAE Admin Console before the SAE settings on the Countess instrument can be used (Figure 2). Once the Countess Application Profile software is installed in the SAE Admin Console, an SAE server (i.e., network computer) is used to connect to the Countess instrument. The SAE Admin Console must operate from a network computer with a static IP address.

Settings view of SAE Admin Console

Figure 2. Interface view of the SAE Admin Console and the Countess Application Profile.

SAE License for Countess SAE Software Solution for 21 CFR Part 11 Compliance Support

Countess SAE Software License for 21 CFR Part 11 is for use with the Countess 3 and Countess 3 FL Automated Cell Counters and supports compliance with 21 CFR Part 11 FDA guidelines for security, auditing, and e-signatures (SAE) using the SAE Admin Console. The SAE Software License is required to activate SAE Mode on the Countess Automated Cell Counter. One license per Countess instrument.

Buy now: license for Countess 3/3 FL SAE Software Solution for 21 CFR Part 11 Compliance Support
Buy now: bundle of Countess 3 FL Automated Cell Counter with license
Instructions for generating license key

SAE Mode on Countess 3 Automated Cell Counters

The SAE Admin Console software allows 21 CFR Part 11 support through enablement of the SAE Mode on the Countess instrument. When SAE Mode is enabled, the Countess instrument connects to the SAE Admin Console via the SAE server (Figure 3). Security, Audit and E-signature settings, as defined in the SAE Admin Console, are implemented on the Countess instrument.

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 Countess 3 and Countess 3 FL Automated Cell Counters can run in SAE Mode through purchase of the Countess SAE Software License.

SAE mode enabled on Countess instrument

Figure 3. Enabling SAE mode on the Countess 3/3 FL instrument.


How does the Countess SAE Software Solution for 21 CFR Part 11 Compliance Support work?

The SAE Admin Console provides the following functionality:

FunctionDescription
System securityControls user access to the software. Three default user roles are provided, one with full privileges (Administrator), one with some privileges removed (Lead scientist) and the other with no privileges (Technologist). Default user roles can be edited, and additional user roles and permissions can be created.
AuditingTracks actions performed by users, and changes to the SAE Admin Console settings. The software automatically audits some actions silently. You can select other items for auditing and specify the audit mode. The auditing function provides reports for audited SAE Admin Console changes and actions.
Electronic signature (e-signature)Determines if users are required to provide a username and password when performing certain functions. You can configure e-signature so that a user can export a signed file and print a signed report. You can also configure the e-signature event to require multiple signatures and to require users with specific permissions to sign.

Additional design features for each function are detailed below:

System security

Access is restricted to authorized personnel via user ID and password.

Auditing

Tracks actions by users and changes performed to the SAE settings. The SAE Admin Console automatically tracks auditable actions silently (including, but not limited to, sign in/sign out, image acquisition, and image exported)
(Figure 5).

Figure 5. 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, Countess Instrument, or other), (3) action, (4) date and username (5) export in readable/printable format (PDF or .txt).


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 (e-signature)

Determines if users are required to fulfill signature requirements before performing specific functions (Figure 6).

Figure 6. 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

Documents

Invitrogen Countess 3 Cell Counting Standard Slide

The Invitrogen Countess 3 Cell Counting Standard Slide is a ready-to-use slide that contains permanently mounted microspheres in a cell counting chamber. Cell counts on the slide range from 0.5 and 1.5 x 106 cells/mL and the microspheres are 15 µm. When used in brightfield, the microspheres mimic the appearance of a 1:1 mixture of live and dead cells stained with trypan blue solution (Figure 7). When using the Countess 3 FL Automated Cell Counter, the microspheres also are fluorescent in a 1:1 mixture providing approximately 50% detection with DAPI and GFP light cubes and approximately 50% detection with RFP, Texas Red, and Cy5 light cubes. The 50% fluorescence populations are shown in both single fluorescence channel counting or dual fluorescence channel counting (Figure 8).

The Countess 3 Standard Slide has several uses and benefits.

  • Confirmation—use as a counting and viability standard.
  • Reproducible—permanently mounted microspheres minimize variability from one count to the next.
  • Convenient—ready-to-use and reusable
     

Figure 7. Side-by-side views of Jurkat staining and Countess Standard Slide.(A) Jurkat cells stained with trypan blue solution. (B) Countess 3 Cell Counting Standard Slide with microspheres mimicking live dead cell counts when used in brightfield.
 

Figure 8. Countess Standard Slide views in different fluorescence channels.(A–C) Countess 3 Standard Slide used to visualize approximately a 50/50 population of beads that fluoresce in two channels including DAPI/RFP, GFP/Texas Red, and GFP/Cy5. (D–H) Countess 3 Standard Slide used to visualize approximately 50% of population fluorescing with the use of different EVOS 2.0 Light Cubes, most commonly: DAPI, GFP, RFP, Texas Red, and Cy5.

Machine-learning algorithm generates accurate counts; autofocus and auto-lighting minimize user-to-user variability

The Countess 3 Automated Cell Counters utilize machine-learning algorithms for fast and accurate focus determination as well as cell and viability counts. Countess instruments are compatible with a broad range of cell types and have been verified for use with several commonly used cell lines and primary cell types. Upon insertion of the slide, the Countess instrument will automatically provide optimized illumination and focus on the cells, which helps to minimize user variation associated with manual focusing and lighting adjustments. Cells ranging in size between ~4 µm and 60 µm and in cell suspension density ranging from 1 x 104 to 1 x 107 cells/mL are optimal for counting.

Bar graph of cell counts of different cell types counted by Attune NxT Flow Cytometer, Countess 3 Automated Cell Counter, and manually with a hemocytometer

Figure 1. Machine-learning algorithms result in highly accurate cell counts, comparable with flow cytometer counts. CHO-K1, HeLa, HEK293, Jurkat, and human PBMCs were counted using the Attune NxT Flow Cytometer (red bar), a Countess 3 FL Automated Cell Counter (blue bar), and manual counting using a hemocytometer and microscope (green bar). The Countess 3 FL Automated Cell Counter and hemocytometer bars represent an average of 6 counts. Error bars indicate standard deviation from 6 independent counts.

Scatter dot graph of cell counts of different cell types counted by Countess 3 Automated Cell Counter, and manually with a hemocytometer

Figure 2. Machine-learning algorithms result in highly precise cell counts with lower variability between counts compared to manual counting. CHO-K1, HeLa, HEK293, Jurkat, and human PBMCs were counted using the Countess 3 FL Automated Cell Counter (blue dots) and manual counting using a hemocytometer and microscope (green dots). The lines represent the median count and the dots demonstrate variance from 6 individual counts.

Bar graph of cell counts of human and mouse PBMCs by Countess 3 Automated Cell Counter and manually with a hemocytometer

Figure 3. Machine-learning algorithms result in highly accurate cell counts with challenging cell types and with more precision than manual counting. Human and mouse PBMCs were counted using the Countess 3 FL Automated Cell Counter (blue bar) and the manual counting method using a hemocytometer and microscope (green bar). The Countess 3 FL Automated Cell Counter and hemocytometer bars represent 6 counts. The error bars represent standard deviation.

Cell clumps counted accurately; debris ignored without gating inputs

Countess 3 Automated Cell Counters are able to accurately count cells that clump together. Whether you currently use automated or manual cell counting methods, obtaining accurate cell counts from samples containing clumpy cells can be difficult. Samples that contain debris add further complexity to cell counting. The Countess 3 Automated Cell Counter automatically excludes debris from cell counts. The machine-learning algorithm of the Countess Automated Cell Counter can clearly identify cell boundaries within clumps of cells and ignores debris, resulting in highly accurate cell counts (Figure 4).

Figure 4. Machine-learning algorithms generate accurate counts with clumpy cells and sample debris. The Countess 3 FL Automated Cell Counter was used to count RAW cells, which are both small and have a propensity to clump. The counting algorithm can resolve the cells in the clump and properly segment and count the cells. Debris is properly omitted from counts.

Small cells accurately counted

Rodent PBMCs are small cells around 5-7 microns and can be challenging to count whether manually on a hemocytometer or on an automated cell counter. The Countess 3 Automated Cell Counter’s machine-learning algorithm is robust and accurately counts these cells in both brightfield and fluorescence modes (Figure 5).

Figure 5. Rodent PBMCs accurately counted with machine-learning algorithm. The Countess 3 FL Automated Cell Counter was used to count small rodent PBMCs. Counts were performed with brightfield lighting (A) and with fluorescence lighting (B).

Streamlined process

There is always an abundance of work awaiting scientists in the lab. The Countess 3 Automated Cell Counter streamlines the process of cell counting. There are several tedious steps it takes to work through the manual cell counting process. The Countess 3 Automated Cell Counter eliminates many of those steps and the hands-on time to perform those steps (Figure 6). This additional time can be applied to other activities in the lab, resulting in a significant advantage when switching from manual to automated cell counting.

Comparison of cell counting processes

Rapid capture

Using the brightfield mode, once the slide is inserted, there is nothing further to do. The Countess 3 counter will automatically illuminate, auto-focus, and auto-count. This saves time with additional menu selections, getting you quickly to the results.

Home screen with Rapid capture enabled

Autosave

By selecting the autosave feature, cell counts and data are automatically saved. Couple this with the Rapid capture mode and the cell counting and data retention process becomes fully automated.

Save Options Screen shows various files that can be saved, data destinations, and editable field for sample name along with field for enabling autosave

Countess Cell Counting Chamber Slides

The disposable slides are convenient for quickly processing cell samples when there are many to process. There is no need to clean the reusable slide and wait for it to dry between cell samples.

Pipet is loading sample into chamber slide

Built-in pre-dilution and cell splitting calculators make any necessary calculations seamless and integrated into the cell counting process. Viewing histograms and any additional desired gating of cell counts are easy to do on the Countess 3 cell counter, and a printable PDF report of your results can be saved and printed.

Pre-dilution calculator

If the cell sample is concentrated and a dilution is required prior to cell counting, the Countess 3 cell counter can quickly and easily calculate the sample concentration. The Countess 3 cell counters can easily calculate or remove calculation of a 1:1 dilution with trypan blue.

Fields to input sample volume, buffer volume and a field to select if concentration should account for 1 to 1 trypan blue dilution

Cell splitting calculator

Easily determine the amount of cell sample and buffer needed for your experiment with the built-in cell splitting calculator. The cell count results are automatically used in the calculation; simply input the desired concentration and the volume needed.

Fields to choose Live or Total cells, desired concentration, and volume needed. At the bottom third of the screen, the Countess 3 instrument informs how much cell solution should be mixed with how much buffer

Easily gate cells and view histograms

Cells can be gated based on cell size, brightness, and circularity to fine-tune what is included or excluded for specific applications. View the histogram by selecting the graph icon and watch the changes in real time as you use the gating features. Using brightfield, the average cell size is aligned on the x-axis. Using fluorescence, the relative fluorescence units (RFU) is aligned on the x-axis.

Histogram of cells detected by GFP fluorescence and the low intensity cells are gated out

Printable report with cell counting results

Using a USB drive or Wi-Fi to establish cloud connectivity on the Countess 3 and 3 FL Automated Cell Counters, you can save your cell count results and images and then transfer them to your own computer. Image files can be saved as TIFF, PNG, or JPEG files, and the results are saved as a CSV file. A printable PDF report with results, images, and settings used can also be saved.

Report file includes summary of cell count concentration results in the different fluorescent channels, the intensity, histograms, and captured cell images

Responsive touchscreen and intuitive interface

The Countess 3 Automated Cell Counter’s screen selections are intuitive and easy to navigate. The LCD screen is a responsive touchscreen, not requiring an external computer. Its 1280 x 800 resolution provides high-quality cell images. The cell images can be supplemented with aids for identifying live/dead counts and, in the Countess 3 FL Automated Cell Counter, the ability to visualize fluorescence. The display is flush across the instrument, making it easy to keep clean. While the touchscreen is increasingly popular, the Countess 3 cell counter can accommodate use with a mouse connected with the USB port in the back of the instrument.

Photo taken from above the Countess 3 cell counter with a good view of the touchscreen

Wi-Fi enabled cloud connection

The Countess 3 Automated Cell Counter can save files directly to the Thermo Fisher Connect cloud-based platform service. By connecting to a local Wi-Fi network with the Wi-Fi dongle, files can be saved to the cloud. Access these files now or later, inside the lab or out – data that is available when and where you need it.

Access your Countess 3 data from anywhere with Wi-Fi cloud connectivity

What is 21 CFR part 11 compliance?

In August of 1997, the U.S. Food and Drug Administration (FDA) released the Electronic Records and Signatures Rule. This is known as 21 CFR Part 11 as it is Part 11 of Title 21 from the Code of Federal Regulations. 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 established by the end user’s institution
  • 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 both the institution’s work process and systems used.


Countess SAE Software Solution for 21 CFR Part 11 Compliance Support

To implement the Countess SAE Software Solution to support the technical 21 CFR Part 11 compliance portion on the Countess 3 and Countess 3 FL Automated Cell Counters, the following components need to be installed, activated, and communicating with each other.

The Countess SAE Software Solution for 21 CFR Part 11 Compliance Support consists of (Figure 1):

  1. SAE Software—used to configure the Security, Audit and Electronic-signature settings for Countess Automated Cell Counter. SAE software consists of the SAE Administrator Console (installed on a server with a static IP address) and SAE Application Profile.
  2. SAE License—Used to activate the SAE settings for the Countess Automated Cell Counter
  3. SAE Mode—Countess Automated Cell Counter software that is remotely connected with the SAE Administrator Console
Icons depicting the 3 components and how they are connected to one another.

Figure 1. The Countess SAE Software Solution for 21 CFR
Part 11 Compliance Support consists of (1) Security, Audit, and e-signature (SAE) software (the SAE Admin Console and the Countess SAE Application Profile software), (2) the SAE License needed to activate the SAE settings for the instrument, and (3) Countess SAE Mode (onboard software).

SAE Software—SAE Administrator Console

The SAE Administrator Console is a component of the Countess SAE Software Solution for 21 CFR Part 11 Compliance Support that allows configuration of the Countess instrument to meet user-specific requirements. The Countess Application Profile is another component that must be installed in the SAE Admin Console before the SAE settings on the Countess instrument can be used (Figure 2). Once the Countess Application Profile software is installed in the SAE Admin Console, an SAE server (i.e., network computer) is used to connect to the Countess instrument. The SAE Admin Console must operate from a network computer with a static IP address.

Settings view of SAE Admin Console

Figure 2. Interface view of the SAE Admin Console and the Countess Application Profile.

SAE License for Countess SAE Software Solution for 21 CFR Part 11 Compliance Support

Countess SAE Software License for 21 CFR Part 11 is for use with the Countess 3 and Countess 3 FL Automated Cell Counters and supports compliance with 21 CFR Part 11 FDA guidelines for security, auditing, and e-signatures (SAE) using the SAE Admin Console. The SAE Software License is required to activate SAE Mode on the Countess Automated Cell Counter. One license per Countess instrument.

Buy now: license for Countess 3/3 FL SAE Software Solution for 21 CFR Part 11 Compliance Support
Buy now: bundle of Countess 3 FL Automated Cell Counter with license
Instructions for generating license key

SAE Mode on Countess 3 Automated Cell Counters

The SAE Admin Console software allows 21 CFR Part 11 support through enablement of the SAE Mode on the Countess instrument. When SAE Mode is enabled, the Countess instrument connects to the SAE Admin Console via the SAE server (Figure 3). Security, Audit and E-signature settings, as defined in the SAE Admin Console, are implemented on the Countess instrument.

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 Countess 3 and Countess 3 FL Automated Cell Counters can run in SAE Mode through purchase of the Countess SAE Software License.

SAE mode enabled on Countess instrument

Figure 3. Enabling SAE mode on the Countess 3/3 FL instrument.


How does the Countess SAE Software Solution for 21 CFR Part 11 Compliance Support work?

The SAE Admin Console provides the following functionality:

FunctionDescription
System securityControls user access to the software. Three default user roles are provided, one with full privileges (Administrator), one with some privileges removed (Lead scientist) and the other with no privileges (Technologist). Default user roles can be edited, and additional user roles and permissions can be created.
AuditingTracks actions performed by users, and changes to the SAE Admin Console settings. The software automatically audits some actions silently. You can select other items for auditing and specify the audit mode. The auditing function provides reports for audited SAE Admin Console changes and actions.
Electronic signature (e-signature)Determines if users are required to provide a username and password when performing certain functions. You can configure e-signature so that a user can export a signed file and print a signed report. You can also configure the e-signature event to require multiple signatures and to require users with specific permissions to sign.

Additional design features for each function are detailed below:

System security

Access is restricted to authorized personnel via user ID and password.

Auditing

Tracks actions by users and changes performed to the SAE settings. The SAE Admin Console automatically tracks auditable actions silently (including, but not limited to, sign in/sign out, image acquisition, and image exported)
(Figure 5).

Figure 5. 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, Countess Instrument, or other), (3) action, (4) date and username (5) export in readable/printable format (PDF or .txt).


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 (e-signature)

Determines if users are required to fulfill signature requirements before performing specific functions (Figure 6).

Figure 6. 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

Documents

Invitrogen Countess 3 Cell Counting Standard Slide

The Invitrogen Countess 3 Cell Counting Standard Slide is a ready-to-use slide that contains permanently mounted microspheres in a cell counting chamber. Cell counts on the slide range from 0.5 and 1.5 x 106 cells/mL and the microspheres are 15 µm. When used in brightfield, the microspheres mimic the appearance of a 1:1 mixture of live and dead cells stained with trypan blue solution (Figure 7). When using the Countess 3 FL Automated Cell Counter, the microspheres also are fluorescent in a 1:1 mixture providing approximately 50% detection with DAPI and GFP light cubes and approximately 50% detection with RFP, Texas Red, and Cy5 light cubes. The 50% fluorescence populations are shown in both single fluorescence channel counting or dual fluorescence channel counting (Figure 8).

The Countess 3 Standard Slide has several uses and benefits.

  • Confirmation—use as a counting and viability standard.
  • Reproducible—permanently mounted microspheres minimize variability from one count to the next.
  • Convenient—ready-to-use and reusable
     

Figure 7. Side-by-side views of Jurkat staining and Countess Standard Slide.(A) Jurkat cells stained with trypan blue solution. (B) Countess 3 Cell Counting Standard Slide with microspheres mimicking live dead cell counts when used in brightfield.
 

Figure 8. Countess Standard Slide views in different fluorescence channels.(A–C) Countess 3 Standard Slide used to visualize approximately a 50/50 population of beads that fluoresce in two channels including DAPI/RFP, GFP/Texas Red, and GFP/Cy5. (D–H) Countess 3 Standard Slide used to visualize approximately 50% of population fluorescing with the use of different EVOS 2.0 Light Cubes, most commonly: DAPI, GFP, RFP, Texas Red, and Cy5.

Countess 3 Automated Cell Counter videos

Countess 3 Automated Cell Counter

Watch a brief video with some of the many features developed for the Countess 3 instruments.

How to use the reusable slide and accelerate your cell counting with Rapid capture

The reusable slide is a cost effective way to perform automated cell counting and Rapid capture will minimize steps when using the Countess 3 Automated Cell Counter in brightfield mode.

How to save your data

Following cell counts, data can be saved in the cloud or to a USB drive. Select from five file types and select Autosave to automatically save the files of your choice.

How to use onboard calculators

Use the pre-dilution calculator to correct for dilutions prior to counting including a quick trypan blue 1:1 dilution correction selection. Use the cell splitting calculator to set up cell culture vessels with the optimal cell densities.


Comparison between Countess 3 Automated Cell Counter and Countess 3 FL Automated Cell Counter

Countess 3 instruments angled toward one another and the Countess 3 FL has 2 EVOS light cubes in the front right side
FeaturesCountess 3
Automated Cell Counter
Countess 3 FL
Automated Cell Counter
Machine-learning algorithm  *  *
1280 x 800 LCD screen  *  *
Wi-Fi enabled cloud connectivity  *  *
Brightfield image & count  
Brightfield auto-lighting  
Brightfield Rapid capture  *  *
Fluorescence images & countsn/aTwo user-changeable fluorescence channels (optional)
Fluorescence auto-lightingn/a  *
Saturated pixel indicatorn/a  *
Autofocus  
Autosave  *  *
Countess Chamber Counting Slides  
Countess Reusable Slide  * 
Pre-dilution calculator  *  *
Cell splitting calculator  
Single-cell data  *  *
* New features in the Countess 3 Automated Cell Counters.
n/a = not applicable.


Ordering information

Countess 3 Automated Cell Counter with Extended Warranty*

Cat. No.DescriptionIncludes
A50298Countess 3 Automated Cell Counter Starter Package + REX Extended Warranty
  • Countess 3 Automated Cell Counter (AMQAX2000)
  • Countess Reusable Slide
  • Countess Cell Counting Chamber Slides - 500 slides
  • Instrument with 3 yr Rapid Exchange (REX) extended warranty**
A49862 Countess 3​ Automated Cell Counter + REX Extended Warranty
  • Countess 3 Automated Cell Counter (AMQAX2000)
  • Instrument with 3 yr Rapid Exchange (REX) extended warranty**
A49891 Countess 3​ Automated Cell Counter + ABRC Extended Warranty
  • Countess 3 Automated Cell Counter (AMQAX2000)
  • Instrument with 3 yr AB Repair Center (ABRC) extended warranty***

*Extended warranty included without additional cost

*Learn more about the Countess 3 Automated Cell Counter Service plans
**Learn more about Rapid Exchange (REX)
***Learn more about AB Repair Center (ABRC) Support

Countess 3 Automated Cell Counter Starter Package

Cat. No.DescriptionIncludes
A49865Countess 3 Automated Cell Counter Starter Package​
  • Countess 3​ Automated Cell Counter (AMQAX2000)
  • Countess Reusable Slide
  • Countess Cell Counting Chamber Slides - 500 slides w/ trypan blue stain (0.4%)
  • One-year standard warranty

Countess 3 Automated Cell Counter

Cat. No.DescriptionIncludes
AMQAX2000Countess 3​ Automated Cell Counter
  • Countess 3​ Automated Cell Counter
  • Countess Cell Counting Chamber Slides (50 slides/box)
  • Countess 3 Disposable Slide Holder
  • Countess Reusable Slide Holder
  • Countess USB drive
  • Power Cord with 4 adapters
  • Countess 3 Automated Cell Counter Quick Reference Card
  • One-year standard warranty

Countess 3 FL Automated Cell Counter with Extended Warranty

Cat. No.DescriptionIncludes
A50299 Countess 3 FL Automated Cell Counter Starter Package + REX Extended Warranty
  • Countess 3 FL Automated Counter (AMQAF2000)
  • Countess Reusable Slide
  • Countess Cell Counting Chamber Slides - 500 slides
  • Instrument with 3 yr Rapid Exchange (REX) extended warranty**
A49892Countess 3​ FL ​Automated Cell Counter + REX Extended Warranty
  • Countess 3 FL Automated Counter (AMQAF2000)
  • Instrument with 3 yr Rapid Exchange (REX) extended warranty**
A49893 Countess 3​ FL Automated Cell Counter + ABRC Extended Warranty
  • Countess 3 FL Automated Counter (AMQAF2000)
  • Instrument with 3 yr AB Repair Center (ABRC) extended warranty***

*Extended warranty included without additional cost

*Learn more about the Countess 3 FL Automated Cell Counter Service plans
**Learn more about Rapid Exchange (REX)
***Learn more about AB Repair Center (ABRC) Support

Countess 3 FL Automated Cell Counter Starter Package

Cat. No.DescriptionThis Kit includes
A49866Countess 3 FL Automated Cell Counter Starter Package
  • Countess 3 FL Automated Counter (AMQAF2000)
  • Countess Reusable Slide
  • Countess Cell Counting Chamber Slides - 500 slides w/ trypan blue stain (0.4%)
  • EVOS Light Cube, GFP 2.0
  • EVOS Light Cubes, RFP 2.0
  • One-year standard warranty

Countess 3 FL Automated Cell Counter

Cat. No.DescriptionIncludes
AMQAF2000​ Countess 3​ FL Automated Cell Counter
  • Countess 3 Automated Cell Counter
  • Countess Cell Counting Chamber Slides (50 slides/box)
  • Countess Disposible Slide Holder
  • Countess Reusable Slide Holder
  • Countess USB drive
  • Wi-Fi dongle
  • Countess Light Cube Removal Tool
  • Power Cord with 4 adapters
  • Countess 3 Automated Cell Counter Quick Reference Card
  • One-year standard warranty
AMQAF2001Countess 3 FL + 21 CFR Software License
  • Countess 3 Automated Cell Counter
  • Countess Cell Counting Chamber Slides (50 slides/box)
  • Countess Disposible Slide Holder
  • Countess Reusable Slide Holder
  • Countess USB drive
  • Wi-Fi dongle
  • Countess Light Cube Removal Tool
  • Power Cord with 4 adapters
  • Countess 3 Automated Cell Counter Quick Reference Card
  • One-year standard warranty

Countess 3 FL Automated Cell Counter - Custom Productivity Package

Cat. No.DescriptionWill provide a custom quote with the selection from the following items:
Request a quoteCountess 3 Automated Cell Counter Custom Productivity Package
  • Countess 3 FL Automated Cell Counter
  • Countess 3 FL Reusable Slide
  • Countess Cell Counting Chamber Slides (Qty 50)
  • Countess Cell Counting Chamber Slides (Qty 500)
  • Invitrogen Trypan Blue Stain (0.4%)
  • EVOS Light Cube, GFP 2.0
  • EVOS Light Cubes, RFP 2.0
  • EVOS Light Cube, DAPI 2.0
  • Invitrogen ReadyCount Green/Red Viability Stain
  • 3 years Rapid Exchange Extended Warranty

Countess 3 Automated Cell Counter with Extended Warranty*

Cat. No.DescriptionIncludes
A50298Countess 3 Automated Cell Counter Starter Package + REX Extended Warranty
  • Countess 3 Automated Cell Counter (AMQAX2000)
  • Countess Reusable Slide
  • Countess Cell Counting Chamber Slides - 500 slides
  • Instrument with 3 yr Rapid Exchange (REX) extended warranty**
A49862 Countess 3​ Automated Cell Counter + REX Extended Warranty
  • Countess 3 Automated Cell Counter (AMQAX2000)
  • Instrument with 3 yr Rapid Exchange (REX) extended warranty**
A49891 Countess 3​ Automated Cell Counter + ABRC Extended Warranty
  • Countess 3 Automated Cell Counter (AMQAX2000)
  • Instrument with 3 yr AB Repair Center (ABRC) extended warranty***

*Extended warranty included without additional cost

*Learn more about the Countess 3 Automated Cell Counter Service plans
**Learn more about Rapid Exchange (REX)
***Learn more about AB Repair Center (ABRC) Support

Countess 3 Automated Cell Counter Starter Package

Cat. No.DescriptionIncludes
A49865Countess 3 Automated Cell Counter Starter Package​
  • Countess 3​ Automated Cell Counter (AMQAX2000)
  • Countess Reusable Slide
  • Countess Cell Counting Chamber Slides - 500 slides w/ trypan blue stain (0.4%)
  • One-year standard warranty

Countess 3 Automated Cell Counter

Cat. No.DescriptionIncludes
AMQAX2000Countess 3​ Automated Cell Counter
  • Countess 3​ Automated Cell Counter
  • Countess Cell Counting Chamber Slides (50 slides/box)
  • Countess 3 Disposable Slide Holder
  • Countess Reusable Slide Holder
  • Countess USB drive
  • Power Cord with 4 adapters
  • Countess 3 Automated Cell Counter Quick Reference Card
  • One-year standard warranty

Countess 3 FL Automated Cell Counter with Extended Warranty

Cat. No.DescriptionIncludes
A50299 Countess 3 FL Automated Cell Counter Starter Package + REX Extended Warranty
  • Countess 3 FL Automated Counter (AMQAF2000)
  • Countess Reusable Slide
  • Countess Cell Counting Chamber Slides - 500 slides
  • Instrument with 3 yr Rapid Exchange (REX) extended warranty**
A49892Countess 3​ FL ​Automated Cell Counter + REX Extended Warranty
  • Countess 3 FL Automated Counter (AMQAF2000)
  • Instrument with 3 yr Rapid Exchange (REX) extended warranty**
A49893 Countess 3​ FL Automated Cell Counter + ABRC Extended Warranty
  • Countess 3 FL Automated Counter (AMQAF2000)
  • Instrument with 3 yr AB Repair Center (ABRC) extended warranty***

*Extended warranty included without additional cost

*Learn more about the Countess 3 FL Automated Cell Counter Service plans
**Learn more about Rapid Exchange (REX)
***Learn more about AB Repair Center (ABRC) Support

Countess 3 FL Automated Cell Counter Starter Package

Cat. No.DescriptionThis Kit includes
A49866Countess 3 FL Automated Cell Counter Starter Package
  • Countess 3 FL Automated Counter (AMQAF2000)
  • Countess Reusable Slide
  • Countess Cell Counting Chamber Slides - 500 slides w/ trypan blue stain (0.4%)
  • EVOS Light Cube, GFP 2.0
  • EVOS Light Cubes, RFP 2.0
  • One-year standard warranty

Countess 3 FL Automated Cell Counter

Cat. No.DescriptionIncludes
AMQAF2000​ Countess 3​ FL Automated Cell Counter
  • Countess 3 Automated Cell Counter
  • Countess Cell Counting Chamber Slides (50 slides/box)
  • Countess Disposible Slide Holder
  • Countess Reusable Slide Holder
  • Countess USB drive
  • Wi-Fi dongle
  • Countess Light Cube Removal Tool
  • Power Cord with 4 adapters
  • Countess 3 Automated Cell Counter Quick Reference Card
  • One-year standard warranty
AMQAF2001Countess 3 FL + 21 CFR Software License
  • Countess 3 Automated Cell Counter
  • Countess Cell Counting Chamber Slides (50 slides/box)
  • Countess Disposible Slide Holder
  • Countess Reusable Slide Holder
  • Countess USB drive
  • Wi-Fi dongle
  • Countess Light Cube Removal Tool
  • Power Cord with 4 adapters
  • Countess 3 Automated Cell Counter Quick Reference Card
  • One-year standard warranty

Countess 3 FL Automated Cell Counter - Custom Productivity Package

Cat. No.DescriptionWill provide a custom quote with the selection from the following items:
Request a quoteCountess 3 Automated Cell Counter Custom Productivity Package
  • Countess 3 FL Automated Cell Counter
  • Countess 3 FL Reusable Slide
  • Countess Cell Counting Chamber Slides (Qty 50)
  • Countess Cell Counting Chamber Slides (Qty 500)
  • Invitrogen Trypan Blue Stain (0.4%)
  • EVOS Light Cube, GFP 2.0
  • EVOS Light Cubes, RFP 2.0
  • EVOS Light Cube, DAPI 2.0
  • Invitrogen ReadyCount Green/Red Viability Stain
  • 3 years Rapid Exchange Extended Warranty

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