ONSET ANNOUNCES NEW SOFTWARE FOR 21 CFR PART 11 COMPLIANCE
BOURNE, MA, January 17, 2007 —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.
Onset Computer Corporation is a world leader in portable data logging and monitoring solutions based on Cape Cod, Massachusetts. The company’s HOBO® data logger and weather station products are used around the world in a broad range of monitoring applications, from verifying the performance of green buildings and renewable energy systems to agricultural and coastal research. Onset has sold more than one million data loggers since the company’s founding in 1981.
Onset Computer Corporation
1-800-564-4377 / 508-759-9500
Onset is a leading supplier and trusted manufacturer of data loggers and monitoring solutions used to measure, record, and manage data for improving the environment and preserving the quality of temperature-sensitive products. Based on Cape Cod, Massachusetts, Onset has been designing and manufacturing its products on site since the company's founding in 1981.