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Intuitive, user-programmable software
The CTS Compleo software helps ensure accuracy and efficiency in cell therapy formulation and filling functions. With an algorithm that cuts calculation time and potential errors, the easy-to-use Protocol Builder software streamlines the development and optimization of protocols, providing simulation of protocols which allows users to verify cell concentration and volume ranges before running samples. It also has additional software options to support controlled access for cGMP environments, and includes features to facilitate 21 CFR Part 11 compliance, supporting reliability and regulatory readiness.
Standard software, The Protocol Builder
The easy-to-use Gibco CTS Compleo System Protocol Builder software, standard on all instruments, efficiently guides users through the protocol development process.
- Supports user-driven protocol design and simulation to help optimize cell usage
- Reduces cryoreagent (active ingredient) exposure with rapid processing
- Handles for variable batch sizes without requiring requalification
As easy as 1-2-3—Using the Protocol Builder software
| Step 1 | Step 2 | Step 3 |
|---|---|---|
| Specify the outputs (doses) required | Define the input variables | Run the simulator to preview key information |
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Using the Protocol Builder software
Key protocol information at your fingertips. Example of Protocol Builder simulator data which provides dosing information, cell concentrations, required diluent volume, cell use percentage and active ingredient exposure time.
Optional “make extra doses” strategy. Scale and support a batch size greater than what is required for the minimal dose specification for a given protocol requalification. This helps ensure maximal usage of the final formulation.
Example of finding limits. The simulator displays the input cell volume and concentration limits within which the protocol can be used.
Using the batch protocol. On the day the batch protocol is to be run, a user loads a protocol (previously created using the Protocol Builder) into the Compleo system user interface and simply enters the required input values.
Software to enable 21 CFR Part 11 compliance
When scaling up to commercial manufacturing, we recommend upgrading to the CTS Compleo SAE Software to enable 21 CFR Part 11 compliance. The software option helps customers prepare for audit and regulatory filing processes through security, auditing, e-signature functionality. Customers maintain the final responsibility for 21 CFR Part 11 compliance.
The CTS Compleo 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 no 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 made to the SAE Admin Console settings. The software automatically audits some actions silently. It also allows the user to select other items for auditing and to 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. Configure e-signatures so that a user can export a signed file and print a signed report. In addition, configure the e-signature to require multiple signatures and to require users with specific permissions to sign. |
Ordering information for available software upgrades
The CTS Compleo SAE Software can be purchased as part of an initial instrument purchase or as a separate, standalone purchase later. The software option requires a system upgrade service by a member of the Global Service and Support team to enable the software.
CTS Compleo system software updates
To review Release Notes and download the latest software and compatible firmware for the Compleo Fill and Finish System, visit the software download page.
For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products.