IT Solutions

Cellex offers various IT solutions for GMP-compliant processes. Here you will find information about our IT services.

CellPrep is a customizable software designed for a computerized GMP environment. The software was developed according to GAMP 5/Annex 11 requirements and is able to represent a multi-stage manufacturing process. CellPrep consists of core modules and further add-ons, which can be used and validated as needed. Interfaces to laboratories and devices are in place and guarantee a comprehensive data exchange.

CellPrep ensures a reliable and traceable coding due to its ability to generate the Single European Code (SEC) and provides a standardized barcode concept (QR Code/ISBT128-Code). Using QR- and barcodes eliminates manual data entry and reduces error sources dramatically, which in return increases the safety standards throughout the whole manufacturing process as well as the product and the patient safety. In addition, predefined data such as release relevant information or occurred deviations can be transferred to corresponding documents automatically.

In regard to customization, the user interface can be adapted according to customers’ process needs and can be subdivided in separate process sections. Within each section, dependencies and plausibility checks can be implemented on defined risky process steps. The entry of manufacturing relevant data will be tracked by the audit trail, which includes every change and its justification. This ensures a constant transparency and reconstruction of each individual manufacturing step.  

CellPrep complies with the regulatory requirements and enjoys a high level of user acceptance. Hence, CellPrep is ideally suitable for companies and institutions which require a manufacturing software that is in accordance with GMP regulations.