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Tempurity System 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
regulations. 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, GALP, JCAHO,
CAP, and local standards. The system includes features for regulated use including, electronic unique IDs embedded in all hardware, Probe ID-reading hardware to assist in calibration and for use with calibration databases, hash algorithms to detect modified data, a write-once architecture that prevents any data from being modified from within the system, and net-upgradeable software and firmware. Tempurity is the only system on the market that communicates directly with many kinds of monitored devices. This means that the value recorded in the Tempurity System is the same as the value displayed on the front panel of the instrument. In this case there are no possible discrepancies in the reading as there could be when temperature is measured by a "second" sensor. Many of our potential pharmaceutical customers will be interested in the 21CFR Part 11 compliance of the system. 21CFR Part 11 compliance has been open to some interpretation and Networked Robotics does not take a "yes or no" stand on the subject. We prefer to link customers to our "Electronic Records Statement" document which is available on request. A reference for the position of the FDA on 21CFR Part 11 compliance can be found here. If you are in the food industry, you are aware of an increased vigilance by the FDA and USDA with respect to food safety. A series of 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 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) Enhance your regulated environmental data compliance |