Bio-CELLMES is a system addressing the information management needs in cell and advanced therapies field. It provides functions allowing cell production enterprises to control all aspects of operations, including creating orders, registering samples, managing cell productions, tracking raw and auxiliary materials’ productions, and managing equipment, personnel and environment.
Bio-CELLMES system is designed following to the guideline of cGMP. It satisfies the enterprises’ needs on regulatory compliance. The system implements rich functions in tracking the enterprise’s whole production process, puts quality management at the core position, and provides audit trails for system operation.
Cell Collection and Preparation
The following functions are available around cell collection and production:
- Order creation and barcode label preparation
- Transportation management and shipping condition recording
- Sample registration
- Production: resource allocation, task management, online SOPs, data integration with equipment
- Environmental QC management
- Bio-Bank management, sample check-in, requisition and check-out control
Cell Transfusion
The following additional functions are available for cell transfusion
- Reinfusion planning and production time coordination
- Product release control and release document preparation
- Change control on Transfusion planning
Cell Production Module
Bio-CELLMES’ Cell Production Module defines and captures detailed operation steps in cell production. For each step, the same procedure of “Preparation”, “Production”, “Quality Control” and “Completion” can be followed to execute tasks. Lab technicians can scan the sample barcode, reagent and equipment barcode to record important information. They can also submit aliquoted sample, with its own unique barcode, to designated QC processes, which can be run in parallel with the Cell production.
With reactive user interface design, Bio-CELLMES is suitable for being used on tablets, which is more convenient to operate in clean room. All of the tasks’ operation instructions are displayed on screen, allowing lab technicians to avoid using paper instructions. It can decreases the chance of contamination in clean rooms.
Besides cell production, auxiliary material production can also be closely followed by Bio-CELLMES. All of operation information is recorded and can be audited in a great details. It will make sure the lab is operated on the highest standard.