FDA Temperature Monitoring
As an FDA-regulated company, you can be audited for your compliance with the regulatory requirements for the environmental conditions in which your biologics or compounds are stored. FDA internal inspection guides reference the word "Temperature" over 250 times, and over 1600 warning letters have been issued that mention the word "temperature".
Whether you are subject to GLP, GMP, or HACCP guidelines, in all regulatory environments you need a written procedure that defines the quality practices for the storage of material and how discrepancies will be handled. It is our experience as a company that these procedures and the relevant data are often examined during an audit.
While manual procedures such as bulb thermometer readings that are hand-written on a form are sometimes acceptable to the FDA, the cost and potential risk of noncompliance when using manual procedures may be of interest to your organization. Automated methods provide better data (i.e. 24 hour coverage) but in regulated settings must be acquired using validated systems, like the Tempurity™ System, that are documented and operated to the standards required by the FDA.
Use Tempurity™ to Satisfy your FDA Temperature Monitoring Requirements
The network-based Tempurity System centralizes the storage of your FDA-regulated environmental data from freezers and incubators throughout your company. Data can be collected directly from high-end scientific freezers and incubators or via Networked Robotics' advanced digital sensors. Data collection is enabled via our proprietary network device called an NTMS.
Networked Robotics' digital temperature probes are engineered with advanced features for regulatory compliance including electronically embedded unique IDs, and the ability to be programmed with calibration dates and calibration offsets that are stored inside the probe.
Tempurity has been validated for FDA standards, including a comprehensive validation suite with specifications, test plan, validation report, and Networked-Robotics-internal procedures for training and the development of our products. The Tempurity System is open to quality audit by you or by government regulatory bodies at our offices in the Chicago area. See compliance features for more detailed information.
Never be surprised. Know the critical environmental history of your samples. Enhanced quality and compliance have never been easier.
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Tempurity will collect data from ALL of your organizations monitored devices, wherever they are in the world. For different perspectives you may wish to read more from specific categories below: