- FDA 21 CFR part 11 Compliant
- Hosted by Tutela
- Stored for 30 Years
- Secure Electronic Records
- Historical Audit Trails
- Mirrored Data Storage
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 ISO9001:2015 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:
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