Onset Computer Corporation Announces New Software for 21 CFR Part 11 Compliance
BOURNE, Mass.–(BUSINESS WIRE)–Onset Computer Corporation, a leading supplier of battery-powered data loggers, today announced that the latest release of its HOBOware® Pro data logger software, version 2.3, helps pharmaceutical and biotechnology companies comply with the U.S. Food and Drug Administration’s 21 CFR Part 11 regulations. These regulations relate to technical and procedural compliance for maintaining electronic records in the pharmaceutical, biotechnology, medical device, and other FDA-regulated industries.
The new HOBOware Pro 2.3 software helps ensure compliance by allowing quality assurance managers, shipping managers and others to detect when data files have been tampered with, and ensure that current data files match actual data originally recorded by HOBO data loggers.
HOBOware Pro 2.3 supports a broad range of HOBO data loggers, which can be used to measure and record temperature, relative humidity and other environmental conditions in pharmaceutical production facilities, incubators, freezers, warehouses and transport vehicles. It is available in both PC and Macintosh versions.
Available immediately from Onset, HOBOware Pro 2.3 is priced at $99. Additional product details can be found at http://www.onsetcomp.com.
About Onset
Onset Computer Corporation has been producing small, inexpensive, battery-powered data loggers and embedded controllers since 1981, and has sold over 1,000,000 loggers that are used throughout the world by over 50,000 customers. The company manufactures a broad range of data logger and weather station products that are used to measure temperature, humidity, light intensity, voltage, and a broad range of other parameters. Onset products are used in a wide range of research, commercial, industrial, and educational applications.
