At the A3P International Congress in Biarritz from 15 to 17 October 2019, our customer RevaTis gave a presentation on how to implement a data integrity strategy in a biopharmaceutical start-up plant. In the presentation, they talked about how two of salamanderU’s solutions helped them improve their data integrity.
RevaTis has developed an innovative and patented technology to obtain pluripotent adult Mesenchymal Stem Cells from a minimally invasive muscle micro-biopsy. They produce frozen undifferentiated muscle-derived stem cells for autologous therapeutic uses, for tissue engineering, for banking and for all the non-therapeutic uses such as research, toxicology, diagnostic and personalized medicine.
Improving data integrity
At first, RevaTis used paper forms for their batch records, and they didn’t have their data double-checked. They therefore needed to reduce the errors in their data and improve their data integrity with a (partially) digital solution.
To support their data integrity, they acquired salamanderU’s complete turnkey unit, including an aseptic isolator with automatic decontamination, a Quality Management System (QMS) and an electronic Batch Record (eBR). salamanderU’s isolators are made of an innovative and flexible building material, namely synthetic resin. This makes them resistant to decontamination cycles, so they don’t rust. The isolators have a control screen (HMI) with login authentification. The electronic Batch Record system, called SmartReg, is voice-controlled. It optimizes the working time and improves control and monitoring, while being compliant to GAMP5.
Thanks to the system, the data goes through a life cycle from individual user access or defined access, raw data, to the simultaneous review by QA and QP and finally to reports saved on a computer server in a secure and closed system with a double drive and a back-up.
The validation progress
This first needed to be validated to ensure it complies with the reglementation of GAMP5. Read all about the computer validation, the validation plan based on a risk analysis, validation best practices, and the reglementation for computer validation in the presentation below. We can already give this away: all the requirements were fullfilled, so there were no remarks during inspection.