Medical Monitoring
- Qualification Protocols
- NIST/NPL Traceability
- Change Request Protocol
- Incident Audit Reports
- FDA and MHRA Compliant
- Joint Commission Compliant
Audit Documentation
The Tutela service website is fully validated and all electronic records are fully FDA 21 CFR part 11 compliant and securely stored in two different geographical locations for up to 30 years.
Our medical monitoring systems meet fully the exacting requirements of the FDA code which includes the use of unique electronic signatures specifically linked to operator names that are fully traceable.
All sensors and transducers are fully NIST/NPL traceable and calibrated as part of the installation process. All compliance audit and validation documentation is published in electronic format on the customer’s private website library.
All secure website user activity is logged for subsequent qualification and audit purposes.
The Tutela website provides an electronic records library for all related audit documentation. The electronic records held on the website include:
- Tutela user manuals
- DQ, IQ and OQ protocols
- Installation validation records
- Sensor calibration records
- Standard operating procedures
- Sensor reading check reports
- System change request records
- Customer generated reports
This means that our customers enjoy not only unbeatable data access at their fingertips through the Tutela GUI, they can rest assured that complete compliance through rigorous data security, traceability and audit trails is guaranteed as standard with a Tutela medical monitoring system.
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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