- Qualification Protocols
- NIST/NPL Traceability
- Change Request Protocol
- Incident Audit Reports
- FDA and MHRA Compliant
- Joint Commission Compliant
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:
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.
Kathy Rogers, Jupiter Medical Center FL.
Michael Vassallo, Southeast Tissue Alliance FL.
an ISO9001:2008 company