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Secure e-Records

Tutela is a truly ‘paperless’ scientific monitoring and recording service.  All electronic records are fully FDA 21 CFR part 11 compliant and securely stored on mirrored servers in two different geographical locations for up to 30 years.

Data gathered by the Tutela wireless temperature monitoring system fully meets the exacting requirements of the FDA code which includes the use of unique electronic signatures specifically linked to operator names that are fully traceable.  In addition our IT servers and databases are regulated and managed through the Company’s ISO9001:2008 quality management system.

FDA 21 CFR part 11 specifically regulates the secure creation, storage and management of electronic temperature records under a strict electronic signature policy that is the gold standard for data compliance in the field of scientific monitoring systems.

Through our rigorous data security protocols, coupled with our 24/7 global data access via web-browser interfaces, our customers enjoy unprecedented data security, access and control of their scientific monitoring processes.

Coupling this level of data security with a authoritative audit trail of sensor data and incidents, Tutela wireless temperature monitoring systems are guaranteed 100% compliant with all regulatory bodies and scientific associations including:
  

  • MHRA
  • CPA
  • NHS
  • BBTS
  • NBS
  • GMP
  • NHSBT

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What People Say

Marion Tozer, Quality Manager, HCA healthcare, HCA Laboratories

“At HCA we are looking for a quality system to match our quality management system in order to meet MHRA and CPA requirements.  We were looking for a flexible system that we can manage.  Going....

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Kathy Rogers, Jupiter Medical Center FL.

We have experienced excellent service and support. As we live in a hurricane zone, it is important to have such a reliable system. The product monitored temperatures even when our internet connection went down. We....

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