Critical to the success of clinical trials in medical research is the stability of the research and storage environment, coupled with a proven audit trail of accurate recordings. Often the research samples are simply priceless or dictate the value of your business.
But do your investors know the risk you are taking with the investment by not monitoring temperature sensitive materials? Comprehensive risk management is important when the loss of often priceless stock in temperature-controlled storage would have a major impact to your business or research, should a failure occur.
While the material itself may not have a value, the importance to any investor now and in the future that this reference material is safeguarded is of paramount importance.
Trained Tutela staff providing based in Hampshire (UK) provide real-time monitoring 24/7 which is the most cost effective solution to protect cell lines, tissue samples and temperature time sensitive products. A personal call identifying the issue with a full audit trail, provide any investor carrying out due diligence that your research is constant and controlled.
The latest MHRA regulations necessitate the regular and rigorous temperature mapping of fridges, freezers and walk in cold rooms, together with Tutela this will demonstrate and provide evidence that your reference materials have not been exposed to temperature variations.
Tutela is an MHRA and UKAS 17025 approved supplier and with over 20 years’ experience in temperature and data monitoring offering full on-site automated solution for mapping temperature excursions. Being UKAS ISO17025 approved means calibration is done on site, is less disruptive, compliant to the Orange book (MHRA) and detailed to meet your certification needs
Whether at pre-clinical, clinical trials or low volume manufacture stage, the credibility of the trial and possible future commercial success of the project is totally dependent on real-time monitoring to ensure compliance at all times..
Manual monitoring and recording at the level of detail needed is time-consuming, a poor use of highly-qualified human resource and lacks the requisite accuracy. Laboratory monitoring systems that do not include some form of remote alarming, cannot be judged truly fail-safe.
Whatever the need, whether monitoring temperature in refrigerated storage, differential pressure in clean-rooms or environmental conditions in stability chambers and incubators, Tutela has the answer to deliver total peace of mind for you and your investors.
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