User-friendly software for optimization of electroporation parameters
Through a simple touchscreen interface, process developers can optimize electroporation parameters like voltage, pulse width, pulse number, and pulse interval for each combination of cell type and payload. When scaling up to commercial manufacturing, there are two software options available to enable FDA 21 CFR Part 11 compliance for a cGMP lab.
CTS Xenon system software features
- User-friendly—the interface is capable of fine-tuning protocol parameters for each combination of cell type and payload
- Connectivity—The OPC UA interface allows connectivity to a 21 CFR Part 11–compliant system or manufacturing execution system (MES) or laboratory information system (LIS) software
- Secure—The software can be locked for operator manufacturing mode (requires upgrade to SAE module)
- Easy updates—Software and firmware updates can be installed through the GUI
- Cloud-based—The system has the capability to connect to the cloud-based Connect Platform
- Digital automation—The system is compatible with the Gibco CTS Cellmation Software add-on, which allows you to control multiple instruments and enables CGMP compliance (21 CFR Part 11)
Software to help with 21 CFR part 11 compliance
When scaling up to commercial manufacturing, we recommend upgrading one of the two software options available, the CTS Xenon SAE Software or the Gibco CTS Cellmation™ Software for DeltaV Systems to help with 21 CFR part 11 compliance. Both software options help customers prepare for audit and regulatory filing processes through security, auditing, e-signature functionality while customers maintain the final responsibility for 21 CFR Part 11 compliance.
Security, audit, and e-signature (SAE) software
The Xenon SAE Software is designed for customers who want to upgrade, standalone instruments. The capabilities include password policies, user role designations, role permissions, tracking of actions and information via an audit log, and electronic signature configuration for specific functions.
Customer preferences for these SAE settings are managed within the SAE Administrator Console (separate software application), which is recommended to be installed on the co-located Rotea system computer to enable uninterrupted communication between the system and the software for continuous tracking.
Functionality of the SAE Administrator Console
| Function | Description |
| System security | 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 highly restricted privileges (Technologist). Default user roles can be edited, and additional user roles and permissions can be created. |
| Auditing | 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 provides reports for audited SAE Admin Console changes and actions. |
| Electronic signature (e-signature) | 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. |
Cellmation software
The Gibco CTS Cellmation Software is an off-the-shelf cell therapy manufacturing solution that provides digital connectivity to DeltaV for a range of modular cell therapy instruments offered by Thermo Fisher Scientific. The open platform allows for flexible management and integration of multiple instruments, helping streamline cell therapy workflows and helping ensure regulatory compliance. Powered by the Emerson DeltaV Distributed Control System (DCS), CTS Cellmation software helps ensure traceable and secure data storage as well as streamlined data management across processes.
Ordering information for available software upgrades
The Xenon SAE Software or the Cellmation Software for DeltaV Systems can be purchased as part of an initial instrument purchase or as a separate, standalone purchase later. Each software option requires a system upgrade service by a member of the Global Service and Support team to enable the software.
CTS Xenon software updates
To download the latest software for the CTS Xenon Electroporation System, see our software download page.
For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products.