Bio-CELL
Bio-CELL
From the perspective of cell production management, most enterprises hope to control all factors surrounding production, such as sample collection, raw and auxiliary materials, instruments and equipment, personnel, environment and process, so that they can make efficient use of resources. Therefore, there is no shortage and redundancy of resources, but production quality can be guaranteed. In addition to the above problem management, bio cellmes also provides product tracking and production process management (including SOP) In the system, from pre job preparation, production process, to completion clearance), QC (product quality inspection, reagent quality inspection, etc.), QA (environmental control, deviation handling, finished product release audit), etc.
The compliance standard of Bio-CELL is FDA Alcoa + CCEA. Combined with the requirements of GAMP5, comply COI (Chain of Identity) COC (Chain of Custody).
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1. MES Function
1. MES Function
It can store the production process and SOP content structurally and support SOP version management;
In the production process, SOP is displayed on the touch screen electronic equipment, and the production personnel carry out the production operation according to the specified production process and SOP to ensure the landing and strict implementation of the process flow;
In the production process, SOP is displayed on the touch screen electronic equipment, and the production personnel carry out the production operation according to the specified production process and SOP to ensure the landing and strict implementation of the process flow;
2. QC Test Function
2. QC Test Function
Bio-CELL can work with different equipment, some equipment if they have driven and Bio-LIMS can customize by assign driver advantage of deeper integration, but a lot of equipment they are very closed that mean they don't exposing their internal process, most of them only have excel document come out as result , for that Bio-LIMS also can support to pass the excel doc and load to the database.
Another type of equipment, they provide API package allow the system develop to call the equipment controller and to get the status information.
3. Quality Management Fucntion
3. Quality Management Fucntion
Support source sample transportation and cell product transportation supervision. Record the temperature and other key parameters of samples and products during transportation;
4. Bio-Bank
4. Bio-Bank
You can manage the sample storage, check in and check out the sample.Requisition is application for sample check out. All the Sample Location can be reality display in system with the key information.
Origin Samples or the Intermediate products can be re-storage to the Bio-Bank in every experiment.
It is flexible to divide the Bio-bank with different number of layers, type of box….
5. Warehouse Management
5. Warehouse Management
Support source sample transportation and cell product transportation supervision. Record the temperature and other key parameters of samples and products during transportation;
6. Bio-API
6. Bio-API
Bio-CELL can work with different equipment, some equipment if they have driven and Bio-LIMS can customize by assign driver advantage of deeper integration, but a lot of equipment they are very closed that mean they don't exposing their internal process, most of them only have excel document come out as result , for that Bio-LIMS also can support to pass the excel doc and load to the database.
Another type of equipment, they provide API package allow the system develop to call the equipment controller and to get the status information.