Medical Monitoring
- FDA 21 CFR part 11 Compliant
- Hosted by Tutela
- Stored for 30 Years
- Secure Electronic Records
- Historical Audit Trails
- Mirrored Data Storage
Secure e-Records
Tutela is a truly ‘paperless’ medical 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.
The service 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 medical 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 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:
North America
- FDA
- Joint Commission
- AABB
- AATB
- USP797
- GAMP
- GxP
Europe
- MHRA
- CPA
- NHS
- BBTS
- NBS
- GMP
- NHSBT
Testimonials
We have experienced excellent service and support. As we live in a hurricane zone, it...
Kathy Rogers, Jupiter Medical Center FL.
Overall our experience with the Tutela system has been very positive. Installing the Tu...
Michael Vassallo, Southeast Tissue Alliance FL.
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an ISO9001:2008 company
