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Article | October 9, 2013
Dyzle BV: Cold chain monitoring technology platform
Supports validated environment for GDP-compliant automated temperature monitoring in the pharmaceutical industry.
Dyzle BV has announced a key feature of its cold chain monitoring technology platform for the pharmaceutical industry. The company’s solution is the first automated measuring system that fits in a validated environment for GDP (Good Distribution Practice). The use of automated systems for monitoring temperature and humidity is now common practice. These systems have proven to be more efficient and cost effective than manual data logging and recording. However, in order to stay compliant with GDP regulations, it is essential that companies are able to validate the monitoring and recording of critical variables like temperature and humidity. This means documentation and processes must be in place to demonstrate that the computerized system being used fits into the GDP-validated environment. This is part of the quality assurance process to ensure pharmaceutical products are consistently stored, transported, and handled according to product specifications and regulations.
Dyzle supports this validated environment for automated measurements. This provides assurance to responsible persons in the cold chain that their reporting system is also able to meet regulatory compliance. Dyzle’s solution automates the mandatory registration and interpretations requirements in the transport, logistics, and storage of temperature-sensitive pharmaceutical products. The company is working with leading organizations such as Teva Pharmachemie, Alliance Healthcare, and Brocacef.
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