NORWOOD, Mass., Aug. 14, 2001 (PRIMEZONE) -- Doxis, Inc., the market leader in Compliance Execution Management, announced today that it has been awarded a patent from the U.S. Patent and Trademark Office.
U.S. Patent No. 6,272,506 entitled "Computerized verification form processing system and method," covers Doxis' ability to dynamically monitor whether information in any field of a form has changed, and to perform a number of other functions that are vital to compliance with FDA 21 CFR Part 11.
"Our patent is central to the functionality of Doxis software, because it embodies key elements of compliance with Part 11. By actively binding data to electronic documents on a field-by-field basis, as it is entered, we have created a system that marries documents to data," said Lewis Bell, CEO and President of Doxis. "The auditable data in our documents can be searched, exported and sorted, without compromising the original document. Re-engineering compliance can be a productivity opportunity, not just another regulatory burden."
Mobile workers in FDA-regulated manufacturing plants and laboratories must document their compliant work processes with auditable records. They commonly use paper forms. A few examples of compliance execution documents that can be automated under the Doxis umbrella include Laboratory Data Sheets, Certificates of Analysis, Non-Conformance forms, Manufacturing Batch Records and Packaging Records, among others.
"Our system was designed to be embeddable in many kinds of enterprise software, to allow users to export and re-purpose the data they collect as they execute and document compliance processes," said Dave Janelle, V.P. of Systems Development for Doxis. "Our strategy was to design a system that was OEM-friendly, that allows existing applications to be made Part 11 compliant."
About Doxis
Headquartered in Norwood, Massachusetts, Doxis is the market leader in Compliance Execution software. The Company's products and services provide efficiencies and competitive advantage life-science businesses in the management of compliance execution requirements. Doxis software automates and controls formerly paper-based compliance execution and captures and re-purposes the data for valuable business use. More information can be found at www.doxis.com.