Tempurity™ System Regulatory Compliance

The Tempurity™ System is designed to meet United States Food and Drug Administration requirements for validated systems. It is designed to be used under the FDA's Good Laboratory Practices and Good Manufacturing Practices guidelines. The system will be useful for compliance with a series of governmental and nongovernmental standards in the pharmaceutical, biotech, food, and medical industries including GLP, GMP, HACCP, JCAHO, CAP, and local standards such as those for food safety.

The Tempurity System has undergone a rigorous validation process. A set of validation documents is available for audit at our facilities in Evanston, Illinois.

The system includes features for regulated use including, electronically readable unique IDs.  calibration information embedded in our digital sensors, hash algorithms to detect modified data, a write-once architecture that prevents any data from being modified from within the system, and net-upgradeable firmware for quality enhancements in the hardware.

Tempurity communicates directly with many kinds of scientific instruments. This means that in these cases the value recorded in the Tempurity System is the same as the value displayed on the front panel of the instrument.

Many of our potential pharmaceutical customers will be interested in the 21CFR Part 11 compliance of the system.   Our "Electronic Records Statement" document  addresses this issue and is available on request. A reference for guidance from the FDA on 21CFR Part 11 compliance can be found here.

Risks of Temperature Non-compliance

If you are in a regulated industry, you are aware of an increased vigilance by the FDA and USDA with respect to documented environmental conditions.. Over 1600 FDA warning letters issued include the word "temperature". These warning letters from the FDA, especially for the seafood processing industry can be found by searching for the word "temperature" here.

For those customers choosing Networked Robotics to perform regulatory installation, all work is done according to compliance with regulatory standards. For those regulated customers choosing to self-install, installation qualification documents are available for low cost and may be executed and approved for each regulated device by the customer. Networked Robotics staff is trained at least once a year on FDA GxP regulations.

The word " temperature" is used over 300 times in FDA inspection guides. Click here for a list of selected FDA internal training documents governing how inspections should be conducted in various industries.                   
 

877 FRZ TEMP ( 877 379 8367)

877 GLP TEMP ( 877 457 8367)