Monitoring system for GMP centers:
It is an essential application for the full traceability of GMP data from hot cells in production sites, radiopharmacies, clinics and laboratories involved in the management of radiopharmaceuticals that need to be in accordance with GAMP 5 and 21 CFR Part 11.
GMP Monitor saves and traces, in particular:
- Events and alarm files
- Isolator Status and / or Flow Chamber
- Operator Activity
All data is stored in encrypted and encrypted format. The use of this equipment can be done through 4 different levels of user, controlled by password.
The GMP Monitor is compatible with Sinergie Theme equipment due to its high level of technology.