Testing conformity with international standards - Clitec offers solutions for pharmaceuticals
The FitoClima stability test chambers meet the requirements of the International Conference of Harmonization (ICH) and are characterized by very high accuracy and reliability. Our devices allow to simulate climatic conditions exactly, this reproducibly over years. Data logging is compliant with ICH Q1A (stability) and FDA 21 CFR Part 11 (compliance) regulations. Flexible shelf configuration allows efficient use of interior space. This allows you to test different container sizes simultaneously and in a space-optimized manner.
You tell us your needs, the organizational framework and the regulatory requirements. We will find a suitable solution for you, coordinate the project with our suppliers as well as your engineering and provide you with the finished system, including training of your employees. We implement the integration into your IT environment as well as the reporting into the documentation and archiving systems in close cooperation with the IT and quality assurance staff.
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