Baltimore, MD - October 17, 2005 - At the RAPS 2005 Annual Conference, QUMAS, the leading developer of enterprise compliance, governance and risk management solutions, and LORENZ Life Sciences Group, a leading developer of document assembly and publishing solutions for regulated environments, today announced a product integration effort that will benefit life science companies by combining document management, approval and submission with the systems needed to fulfill complex regulatory compliance mandates. Integration was completed by LORENZ using the QUMAS Web Services SDK. Testing and certification was performed jointly by QUMAS and LORENZ.
The integrated offering consists of QUMAS's QUMAS Compliance Suite coupled with docuBridge's submission management solution.
QUMAS Compliance Suite is a complete compliance solution that allows Life Sciences firms to initiate enterprise-wide compliance programs covering many regulations with a single solution. The QUMAS Compliance Suite provides an overall framework and record system for centrally storing and managing documents, and automating processes related to compliance activities.
docuBridge is a leading submission management solution (drug registration dossiers) that enables life sciences organizations to compress the regulatory submission compilation, management and publishing time to improve speed to market for new drugs, cost control, and productivity.
QUMAS integration with docuBridge will benefit users by allowing regulatory publishers to work directly with the controlled repository to access the current, effective version of any document needed for submission to the regulatory agency. In addition, the tight integration of the CFR21 Part11 Compliant content repository and the XML capable submission management system will ensure that the Submission Lifecycle and the Content Lifecycle are always synchronized. At the RAPS 2005 Annual Conference, QUMAS representatives will be available at booth 209 and 211 to discuss and demonstrate the solution.
"Our new combined solution enables life sciences companies to drastically reduce time to market for new drugs or medical products, since it reduces the lifecycle process by applying order to document handling," said Paul Hands, CEO of QUMAS. "We have utilized our open systems architecture to bring all the pieces together for an enterprise-level compliance solution that addresses submission lifecycle management."
"The QUMAS QUMAS Compliance Suite complements docuBridge, and will enable our customers to satisfy the critical need to be in compliance with stringent FDA policies that govern how documents are written, reviewed and approved, while at the same time adhering to good business practices," said Raoul-A Lorenz, Vice President of Sales and Marketing at LORENZ.
"The solution combines the strengths of each product and is critical to customers in a regulated environment, QCompliance for the document life-cycle and docuBridge for the submission life-cycle. The seamless integration enables customers to realize the benefits of both systems and thus increases a firm's overall return on investment for both the docuBridge and QCompliance solutions," added Raoul.
About LORENZ Life Sciences Group
LORENZ Life Sciences' mission is to develop document assembly and publishing solutions for regulated environments within life sciences and help customers progress in their transition towards a digital world. For further information, please visit http://www.lorenz.cc.
docuBridge is a software application that manages the complete development process of submissions (drug registration dossiers) from source document handling over submission compilation to publishing and life cycle management.
With over a decade of experience, QUMAS provides a proven enterprise compliance management solution developed specifically for Life Sciences companies of all sizes and needs. Recognized as the world leader in Enterprise Compliance, Governance and Risk Management, the company has over 250 customer deployments including 5 of the top 10 Life Sciences firms.
QUMAS is the only vendor that offers a suite of products that enables Life Sciences companies to achieve sustainable, enterprise-wide compliance with a broad range of solutions for 21 CFR Part 11, cGxP, Quality, Regulatory Affairs and Clinical Operations.
QUMAS provides highly configurable applications, ready for validation and deployment within regulated environments. Based on open systems platforms, QUMAS technology integrates seamlessly with existing corporate databases, applications, operating systems and hardware from most major vendors.
For more information visit http://www.qumas.com.
All trade names, trademarks, and service marks are the rightful property of their respective owners.
Director of Marketing
Dr. Olaf Schoepke
LORENZ Life Sciences Ltd.
44 (0)1483 549 053