Secure Electronic Records
The Tutela wireless temperature monitoring system is completely paperless providing scientific monitoring and recording data securely. All electronic records generated in the Tutela system are fully FDA 21 CFR part 11 compliant. Records are securely stored on mirrored servers in multiple geographical locations for up to 40 years.
The data gathered by the Tutela system fully meets the requirements of the FDA code. This includes the use of unique electronic signatures specifically linked to operator names that are fully traceable. In addition, Tutela’s 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.
The remote monitoring data is accessible 24/7 using any device able to support a web-browser and through our rigorous data security protocols, our customers enjoy unmatched data security, access and control of their monitoring processes.
Pairing our high level of data security with a solid audit trail of sensor data makes the Tutela wireless temperature monitoring system the most robust system available.
Guaranteed 100% compliant with all regulatory bodies and scientific associations including: