New Software Available For Compliance With The FDA's 21 CFR Part 11 Rule

Onset Computer Corporation, a supplier of battery-powered data loggers, recently announced the release of its HOBOware® Pro data logger software, version 2.3, which 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 enabling 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. The software is available in both PC and Macintosh versions.

HOBOware Pro 2.3 is priced at $99. Additional product details can be found at