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Software updates
Following the original release of Countess 3 and Countess 3 FL automated cell counters, continual innovations are made to the instrument software. Keep your Countess instrument functioning at peak performance with the latest improvements and features by downloading the latest software, including the 21 CFR Part 11 compliance option.
GMP-ready, 21 CFR Part 11 compliance support software
The Countess SAE Software Solution is an optional software module that supports electronic record-keeping that is compliant with the US Food and Drug Administration's Electronic Records and Signatures Rule, Part 11 of Title 21 of the Code of Federal Regulations (21 CFR Part 11). This rule defines the requirements for use of electronic documents in place of paper documents.
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 while 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.
Capabilities of the software includes restriction of unauthorized users, password policies and expiration dates, defined user permissions and roles, tracking of all data changes through an audit log, audit reports, and on-board electronic signature (e-signature) workflows. All Countess 3 and Countess 3 FL automated cell counters can run in SAE Mode after purchasing the Countess SAE Software License. To achieve 21 CFR Part 11 compliance, your institution will also need to establish and document standard operating procedures in a compliant way.
Countess software components
The Countess SAE Software Solution comprises three components that communicate with each other.
- SAE Software is used to configure the Security, Audit, and E-signature (SAE) settings for the Countess Automated Cell Counter. The SAE Software consists of the SAE Administrator Console (installed on a networked computer server with a static IP address) and the SAE Application Profile.
- SAE License is used to activate the SAE settings for the Countess Automated Cell Counter.
- SAE Mode runs on the Countess Automated Cell Counter and connects remotely to the SAE Administrator Console.
SAE Administrator Console
The SAE Administrator Console is the 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. Another component, the Countess Application Profile, must be installed on the SAE Admin Console before the SAE settings can be used. Once the Countess Application Profile software is installed on the SAE Administrator Console, an SAE server (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.
Figure 1. Interface view of the SAE Admin Console and the Countess Application Profile.
SAE License for Countess SAE Software Solution
The 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 using the SAE Admin Console. One SAE Software License is required to activate SAE Mode on each Countess Automated Cell Counter.
SAE Mode on Countess 3 Automated Cell Counters
The SAE Admin Console software allows 21 CFR Part 11 support by enabling 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. 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.
Figure 2. Enabling SAE mode on Countess 3 and 3 FL automated cell counters.
Functionality
Functionality of the SAE Administrator Console.
System security
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Controls user access to the software through user IDs, passwords, roles, and permissions. 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. |
Auditing
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Tracks 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 offers reports for audited SAE Admin Console changes and actions. |
Electronic signature
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Determines the functions for which users are required to provide a username and password. You can configure e-signatures 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. |
System security
Access is restricted to authorized personnel via user ID and password.
Figure 3. Interface of the SAE Administrator Console showing new user account creation.
Auditing
The auditing function of the SAE Admin Console tracks actions by users and any changes to SAE settings. Actions tracked silently include signing in and out, image acquisition, and image exports.
Figure 4. SAE Admin Console audit history.
The Audit History tab of the SAE Administrator Console (1) lists action, system configuration, and application object records. For each event, it shows the (2) application, (3) action, and (4) date and user. You can also (5) export the records in readable or printable (.txt or PDF) format.
Within the auditing function, there are options to select specific user actions to audit and whether the audits will be silent, optional, or required. In addition, reports can be generated for user actions, SAE module changes, and software or instrument actions and events.
Electronic signatures
The e-signature function of the SAE Admin Console determines the functions for which users must fulfill signature requirements.
Figure 5. SAE Admin Console e-signature settings.
The e-signature tab of the SAE Administrator Console lets you (1) customize the meanings of e-signatures, (2) choose how many signatures are required by meaning and role, and (3) choose the type of data signed for specific meanings.
Within the e-signature function, you can configure how many users in different roles must sign each e-signature event. You can also create separate meanings and customize the signature requirements for each.
For Research Use Only. Not for use in diagnostic procedures.