Cell culture service digitization

Our client is an international pharmaceutical company operating in the human and animal health market. In the highly regulated healthcare sector, ensuring the security and traceability of critical data is now essential to comply with various standards (ISO, 21 CFR Part 11…). Our client aims to move towards a custom solution, GxpManager, to ensure the traceability of its cell culture service.

By moving away from the manual methods used so far (paper and Excel® spreadsheets), our client aims to ensure the integrity of the generated data and thus the regulatory compliance of its cell culture service. Regulatory compliance is a priority for this Life Sciences sector company. Our client must notably comply with the 21 CFR Part 11 standard, which imposes criteria that computerized systems must meet (access control, electronic signature, electronic records) to ensure data security and integrity. The solution must be scalable and adapt to future changes in internal procedures and external regulations. The solution must be able to integrate with external software, particularly with cell count calculation automates, on significant exchange frequencies.

The GxpManager application solution must ensure the traceability and integrity of data from the various processes of the cell culture service:

• Order listing management: the solution must be able to integrate with an external system managing cell requests.
• Stock management: Receipt, labeling, storage, and removal of cells with location management.
• Culture medium preparation: culture sheets, labeling, storage…
• Planning of cultures and all associated tasks using a retroplanning approach (based on a GANTT chart) so that cells are delivered in the right quantity, quality, and time: medium preparation, cell thawing, culture duration, passages…, each task must be planned and traced.

Native functionalities of the GxpManager platform

• Audit trail: all modifications are tracked to ensure data integrity.
• Electronic signature
• Workflows: to facilitate process advancement.
• Versioning: preservation of the history of previous versions.
• Access management: to create user profiles with different levels of rights (read, write, delete, or execute).