As the leader in providing integrated quality management software systems to companies all around the world, MasterControl is making news and leading the way in solving business problems for all types of regulated manufacturers.
SALT LAKE CITY– December 14, 2007– MasterControl Inc. today announced the development and availability of an integration tool that connects with LORENZ Life Sciences Group submissions management solutions. The integration product improves life science companies’ ability to manage electronic submissions to the FDA and similar regulatory agencies.
“The synergy created by integrating MasterControl and LORENZ solutions significantly impacts both companies’ customers, present and future,” said Michael Bothe, MasterControl vice president of business development. “By integrating two powerful products, we have the joint potential to offer life science professionals the most complete sets of solutions imaginable.”
The connector is currently available for sale and is already up and running at one joint customer site that was facilitated by Iperion, a mutual partner of MasterControl and LORENZ. “The integration of MasterControl with LORENZ solutions enhances joint customer’s submissions publishing and management capabilities, beginning from the document creation process and right across the complete submission life cycle,” said Karel Bastiaanssen, Managing Director of Iperion. The integration allows MasterControl™ users to create submission-ready documents and control, track, and collect documents in a centralized and secure electronic platform. MasterControl also allows users to collaborate virtually on documents and makes it possible to automatically route, escalate, approve, and control revisions of documents. LORENZ solutions can be used for the final linking and proofing of required documentation, assembly of the electronic regulatory submission, and management of the submission throughout its lifecycle.
"We have already demonstrated joint success in the electronic submissions marketplace through seamlessly joining MasterControl and LORENZ technology solutions to address current customer needs in collecting documentation from document management systems and effectively managing submissions impacting their bottom-line," said Wolfgang Witzel, president of Lorenz Life Sciences Group. "We are pleased to join forces with MasterControl in Europe and in North America and look forward to more opportunities to provide our integrated and streamlined e-submissions solutions."
LORENZ Life Sciences Group has been assisting customers and regulatory agencies globally since 1989 by offering solutions to address their authoring (authorBridge), labeling (labelBridge), tracking (drugTrack) and submission publishing and submission management needs (docuBridge).
The MasterControl solution suite has been specifically engineered to automate and effectively manage document control, change control, audits, corrective and preventive actions (CAPA), regulatory training, nonconformance disposition, customer complaints, and other GxP processes. MasterControl’s user-friendly software solutions are configurable and provide continuous compliance with regulations such as FDA guidelines and ISO standards. The Submissions Gateway™ and Submissions Locker™ modules of the MasterControl solution suite facilitate electronic delivery of FDA submissions by providing control in assembling and tracking vital documentation.
About LORENZ Life Sciences Group
LORENZ Life Sciences Group (www.lorenz.cc) develops and markets software solutions for the life sciences market. LORENZ's solutions are geared specifically for submission assembly, review, publishing, validation and management. As the number one supplier of submission management systems in the world for U.S., European and Japanese submissions, LORENZ is currently the market leader in producing eCTDs. With over 100 installations in 20 countries, LORENZ has built a reputable customer base. For more information, call 866-286-0051.
About MasterControl Inc.
MasterControl Inc. is a worldwide leader in providing GxP process and document management software solutions for life science companies. The MasterControl solution is easy to use, easy to deploy, easy to validate, and easy to maintain. MasterControl facilitates regulatory compliance and incorporates industry best practices for automating and connecting every stage of the product development cycle. MasterControl drives down total ownership cost and enables customers to extend their investment across the enterprise by combining an integrated platform with a continuum of risk-based software validation products and services. Since 1993 hundreds of companies around the world have relied on MasterControl for easier compliance, faster validation, and better process management. For more information, visit the MasterControl website or call 800-825-9117.