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Achieving FDA and EMA Compliance in Temperature Monitoring
Pharmaceuticals and biologics often require strict temperature control to stay safe and effective. Deviation from these conditions can cause degradation. Regulatory bodies like the FDA and EMA enforce strict guidelines to ensure product quality during manufacturing, storage, and transport.
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NECSO Cambridge 2023
Where do the majority of your temperature excursions occur? Why not eliminate them?
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Q&A with Claes Kalderén: Our European Sales Manager
Even though Claes Kalderén only joined TSS at the beginning of 2022, his vast experience has allowed him to hit the ground running. As European Sales Manager, he is responsible for forging new customer relationships across the continent.
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Mind the gap: the real-world impact of data gaps in clinical trials
Although clinical trials can cover a huge range of formats, from small academic assessments to global, multi-billion dollar ventures, they all have one thing in common. Their success (or failure) is determined by a consistent approach to data.
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Achieving FDA and EMA Compliance in Temperature Monitoring
Many pharmaceuticals and biological products require specific temperature conditions during manufacturing, storage, and transport to ensure their quality and safety. Failure to maintain these conditions can lead to product degradation, making them less effective or even dangerous. To protect public health, regulatory authorities like the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have established strict guidelines to manage these products. To comply with these regulations, life science companies must adopt advanced temperature monitoring systems that can track and record conditions continuously and reliably. This whitepaper explains the main requirements from both the FDA and EMA, the role of technology in maintaining compliance, and the best practices for setting up effective temperature monitoring systems.
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TSS launches innovative Bluetooth powered temperature monitoring solutions
TSS introduces a new era of efficiency, with next-generation Bluetooth Low Energy temperature monitoring solutions that help life science supply chain professionals automate their processes for time and cost savings while securing patient safety.
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