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An innovative start-up company aims to enter the biotechnology market with superior, cost-effective allografts and regenerative clinical solutions. Up to 100,000 allografts are expected to be processed annually immediately upon completion of the manufacturing facility.
As a participant in a highly regulated market, the company is looking for a user-friendly environmental monitoring system and an experienced partner who can help them set up GxP-compliant production and logistics.
The challenge: In addition to deciding on an environment monitoring system with all details, User Requirement Specifications (URS), Standard Operation Procedures (SOP) and the production site have to be developed. Always taking into account all GMP guidelines.
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.
