QUMAS R&D Suite Selected By SQI Diagnostics For Automated Compliance Solution

QUMAS, a leading provider of quality management and regulatory affairs solutions, recently announced that SQI Diagnostics Inc., a medical systems automation company focused on evolving laboratory-based biomarker testing, has selected the QUMAS R&D Suite as its compliance solution for content and submissions management.

The QUMAS R&D Suite -- an effective R&D strategy in a box --will assist SQI Diagnostics in expediting the new drug application process with better quality submissions, fewer iterations and shortened review and approval cycles. The QUMAS R&D Suite allows SQI Diagnostics to integrate document and submissions management into one seamless lifecycle.

SQI Diagnostics is a Canadian diagnostic systems company focused on developing and launching an automated, multiplexed immunoassay platform serving the human healthcare market. The company targets the $1.4 billion autoimmune disease market, with initial products for rheumatoid arthritis and thrombosis in development.

SQI Diagnostics is the third customer win for QUMAS in the Canadian market in 90 days.

"As a company that is growing at a rapid rate, we have been looking for a solution that not only meets imminent FDA submission requirements, but one that also has the flexibility to address future government regulations and control mandates," said Claude Ricks, Chief Executive Officer of SQI Diagnostics. "QUMAS is a comprehensive solution that is very flexible and is best suited to address the constant change and multiple regulatory requirements of a corporation such as SQI."

Over the past quarter, we've seen continued traction for the QUMAS R&D Suite because it gives life sciences companies all the essentials for submissions management," said Ken Hayward, executive vice president of QUMAS. "This validates our strategy of rolling out bundled solutions to customers in the life sciences and financial services markets. We expect to see a similar demand for the additional suites that we'll offer over the next year."

About SQI Diagnostics
SQI Diagnostics is a medical systems automation company focused on evolving laboratory-based biomarker testing. Using automation and proprietary miniaturization technologies, SQI Diagnostics significantly improves the economies of scale for laboratories performing multiple biomarker testing at high volumes, allowing them to deliver patient results faster using less labor and fewer resources. SQI Diagnostics' initial products target the $1.4 billion autoimmune disease market, with initial products for Rheumatoid Arthritis and Thrombosis scheduled for launch in 2008. SQI Diagnostics is based in Toronto, Canada. For further information please visit www.sqidiagnostics.com.

About QUMAS
QUMAS is a leading developer of enterprise compliance management solutions designed to help life sciences organizations meet industry and government standards for 21 CFR Part 11, cGxP, Quality, Regulatory Affairs and Clinical Operations. With over a decade of experience, QUMAS is helping companies accelerate business processes, reduce costs and improve quality. From content lifecycle management, business process and change management to reporting and analysis, QUMAS Compliance Suite is successfully enabling global life science organizations to proactively manage their regulated content and processes in a secure and compliant way. For more information visit www.qumas.com.

SOURCE: QUMAS