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Bio-CELL

Bio-CELL is a digital cell and gene therapy solution that supports COl (Chain of Identity) and COC (Chain of Custody). The compliance standard of Bio-CELL is FDA Alcoa + CCEA. Combined with the requirements of ISPE GAMP5-2, the Electronic data (EDP) that basically meets the requirements is constructed.

Bio CELL

From the perspective of cell production management, most enterprises aim to control all factors involved in production, including sample collection, raw and auxiliary materials, instruments and equipment, personnel, environment, and processes. This enables them to utilize resources efficiently, avoiding both shortages and redundancies, while ensuring production quality. Beyond managing these aspects, bio-cell also offers product tracking and production process management within its system. This includes SOP (Standard Operating Procedures) for pre-job preparation, production processes, and completion clearance, as well as QC (product quality inspection, reagent quality inspection), and QA (environmental control, deviation handling, and finished product release audit).

Blockchain Development

MES Function

The MES Function structurally stores the production process and SOP content, supporting SOP version management. During production, the SOP is displayed on touch-screen electronic devices, allowing production personnel to follow the specified processes and SOPs. This ensures proper execution and strict adherence to the process flow.

QC Test Function

The QC (Quality Control) Test Function ensures that all laboratory processes, from sample collection to data analysis, adhere to stringent quality standards. It involves a series of automated and manual tests designed to detect any deviations or errors in the sample processing workflow. By meticulously tracking and documenting each step, the QC Test Function helps maintain the integrity and accuracy of laboratory results, ensuring reliable data for research, diagnostics, and product development. This systematic approach to quality control is essential for meeting regulatory requirements and achieving scientific excellence.

Warehouse Management

The warehouse management system supports supervising source sample and cell product transportation, recording temperature and other vital parameters of samples and products during transit.

Bio-Bank

The Bio-BANK system features a user-friendly graphical touch-screen drag-and-drop interface, making it ideal for all types of biological banks, as well as cell and sample storage and application enterprises. This system is designed for easy extensibility, utilizing a relative sample approach for extension management. Despite its simplicity, it is a robust and powerful tool, offering both ease of use and comprehensive functionality.

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