Honeywell POMS partners with Doxis to provide compliance execution software to clinical trials industry

Under the terms of the agreement, Honeywell POMS will offer the Doxis Compliance Execution software as part of its POMS Clinical Manufacturing Solution (CMS).



Under the terms of the agreement, Honeywell POMS will offer the Doxis Compliance Execution software as part of its POMS Clinical Manufacturing Solution (CMS).

According to Doxis, the software is designed to transform manual business processes that use paper compliance forms, into Internet-based 21 CRF Part 11-compliant, automated business processes.

"Doxis provides a unique advantage for users of POMS CMS, by complementing and extending the POMS footprint for compliance data management," said Wayne Castner, COO of Honeywell POMS. "With Doxis, compliant data presentation and collection can occur from any desktop, device, or the Internet. The first combined POMS/Doxis application will be to integrate POMS customers' clinical request management process with their clinical supplies manufacturing process. This integration will allow clinical customers to streamline their internal supply chain, reduce work-in-process inventories for clinical trails, and improve the productivity and efficiencies of clinical trials coordinators and planners."

"Our patented technology is the key component of Doxis software," said Lewis Bell, CEO and President of Doxis. "It embodies all the elements of compliance with 21 CFR 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. The auditable data in our documents can be searched, exported, and sorted, without compromising the original document. Engineering compliance becomes a productivity opportunity, not just another regulatory burden.

"Integration of Doxis Compliance Execution Management software with POMS CMS allows Internet access by authorized persons in real time from the plant floor to the global supply chain, and provides POMS and other integrated applications with instant visibility to data on regulated processes, said Cartner. Compliance records can be made rapidly, with the confidence that audit trails are maintained for all activities, as required by the FDA. POMS CMS then ensures that all activities maintain compliance with regulatory requirements. The integration of Doxis to POMS provides clinical manufacturers with a solution that extends far beyond the electronic replacement of paper-a true flow of information from the document to the database is established.