How to Implement a Data Integrity Strategy in a Biopharmaceutical Startup

At the A3P International Congress in Biarritz from October 15 to 17, 2019, our client RevaTis gave a presentation on how to implement a data integrity strategy in a biopharmaceutical startup. In this presentation, they explained how two of salamanderU's solutions helped them improve their data integrity.

About RevaTis

RevaTis has developed an innovative and patented technology to obtain pluripotent adult mesenchymal stem cells from minimally invasive muscle microbiopsy. They produce frozen undifferentiated muscle stem cells for autologous therapeutic uses, tissue engineering, banking, and all non-therapeutic uses such as research, toxicology, diagnostics, and personalized medicine.

Improving data integrity

Initially, RevaTis used paper forms for its batch records, and their data wasn't double-checked. They needed to reduce errors in their data and improve their data integrity with a (partially) digital solution.

To support their data integrity, they purchased the complete turnkey unit from salamanderU, including an aseptic isolator with automatic decontamination, a quality management system (QMS), and an electronic batch record (eBR). salamanderU isolators are made of an innovative and flexible construction material: synthetic resin. This makes them resistant to decontamination cycles and thus prevents rust. The isolators feature a control panel (HMI) with login authentication. The electronic batch record system, called SmartReg, is voice-controlled. It optimizes work time and improves control and monitoring, while also complying with the GAMP5 standard.

Through this system, data goes through a lifecycle from individual user access or defined access, to raw data, to simultaneous review by QA and QP and finally to reports saved on a computer server in a secure and closed system with dual drive and backup.

Validation progress

This first had to be validated to ensure compliance with GAMP5 regulations. You'll find all the details about the IT validation, the risk-based validation plan, validation best practices, and IT validation regulations in the presentation below. We can already tell you: all requirements were met, so there were no comments during the inspection.