In the extremely regulated biotechnology market, all business decisions, including the selection of a suitable environmental monitoring system, must be made with due regard to the applicable GMP guidelines. Under these conditions, an innovative start-up company wants to enter the biotechnology market with superior, cost-efficient allografts and regenerative clinical solutions. Next to a user-friendly environmental monitoring system, they are also looking for an experienced partner who can support them in setting up GxP-compliant production and logistics.

In this case study, you will learn how a regenerative medicine start-up company:

• was looking for a simple, easy-to-install environmental monitoring system as a critical part of a full GMP facility;
• found an experienced partner providing them with GxP services, such as consulting and temperature mapping; and
• implemented a fully-compliant, user-friendly environmental monitoring system with future scalability and integration of real-time cold chain monitoring.