Total compliance - Total peace of mind The Tutela service fully meets the exacting requirements of the FDA code which includes the use of unique electronic signatures specifically linked to fully traceable operator names. In addition, all of 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. This strict electronic signature policy is the gold standard for regulatory compliance in the field of medical monitoring systems. Through rigorous data security protocols, coupled with 24/7 global access via secure web-browser interfaces, our customers enjoy unprecedented data security, access and control of their medical monitoring processes. Coupling this level of data security with a rock-solid audit trail of sensor data and incidents, Tutela medical monitoring systems are guaranteed 100% compliant with all regulatory bodies and medical associations including FDA, Joint Commission, AABB, AATB, USP797, GAMP, GxP and many more. Remote alarm center On top of all this, the 24/7 Tutela remote alarm monitoring center is manned by real human beings who will call your specified staff with any deviation from norm to ensure you can take action before it becomes a compliance issue and /or serious financial loss. www.tutelamedical.com Tutela Monitoring Systems LLC • 14930 North Florida Avenue • Tampa FL 33613 Telephone: 941 462 1067 • Email: salesus@tutelamedical.com designed & produced by - www.snap-marketing.co.uk job ref. genesis 6463
Genesis II
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