SOURCE: MasterControl

MasterControl

February 07, 2017 10:10 ET

MasterControl and LORENZ Life Sciences Group Celebrate Decade Long Partnership and Integration in Streamlining eCTD Submissions

SALT LAKE CITY, UT--(Marketwired - Feb 7, 2017) - MasterControl, a leading global provider of enterprise quality management systems (EQMS) and LORENZ Life Sciences Group, a leading global Regulatory Information Management Solutions provider have been demonstrating joint success at customers streamlining and integrating their document management and submission management solutions respectively for a decade.

"Integrating with an industry leader, MasterControl, has been providing a seamless way for customers to drag-and-drop documents that are stored and managed in the MasterControl documents module. This allows users to easily build an Electronic Common Technical Document (eCTD) submission in docuBridge," said Yaprak Eisinger, Managing Director, LORENZ North America. "Our partnership with MasterControl aligns with our goal to streamline the e-submission processes for companies and regulatory agencies around the world."

LORENZ docuBridge will be integrated with MasterControl v 11.6 with the release of 5.10. This is the natural evolution of integration with previous MasterControl releases v9, v10 and v11. In recent updates, MasterControl introduced new APIs, which enabled LORENZ to better integrate its functionality with features that were not available in previous versions. One of the key new features is the ability to use document property values from MasterControl to automatically populate eCTD attributes like Manufacturer, Substance, Product and Study Number. Customers will also be empowered to more easily compile their eCTD submissions by flagging items in MasterControl at any time that will need to be part of the submission.

"The LORENZ docuBridge is a well-established system for small, medium and large companies to compile, publish, manage and review electronic submissions," said Patricia Santos-Serrao, RAC, director of clinical and regulatory solutions of MasterControl. "Leading health agencies in Europe as well as Health Canada have been using LORENZ docuBridge to view incoming submissions for many years, and last October, the FDA awarded them a contract to be FDA's eCTD Validation and Review Software as well. Partnering with LORENZ was a solid strategic move to enable our mutual clients a streamlined method for submissions such as New Drug Applications, Investigational New Drug Applications, Master Files and so on to regulatory bodies."

LORENZ docuBridge complies with all global eCTD standards, NeeS, VNeeS, AMNOG, paper submissions and more.

About LORENZ Life Sciences Group
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ has an array of Regulatory Information Management solutions geared towards industry, health authorities and academia which enable enforcing compliance globally. LORENZ's tried and tested portfolio offers Product Registration/IDMP, Submission Assembly, Validation and Management, Publishing/eCTD, Regulatory Planning and Tracking products and related services. Interoperability between LORENZ products and third party solutions, as well as the ability to automate processes allow LORENZ customers to enhance operational efficiencies. With over 600 paid installations in over 30 countries and an average customer growth of 10 new customers per month in 2016, LORENZ has a strong worldwide customer base.

About MasterControl
MasterControl produces software solutions that enable regulated companies to get their products to market faster, while reducing overall costs and increasing internal efficiency. MasterControl securely manages a company's critical information throughout the entire product lifecycle. MasterControl software is known for being easy to implement, easy to validate and easy to use. MasterControl solutions include quality management, document management, product lifecycle management, audit management, TMF document management, training management, document control, bill of materials, supplier management, submissions document management, and more. Supported by a comprehensive array of services based on industry best practices, MasterControl software provides our customers with a complete information management solution across the entire enterprise. For more information about MasterControl, visit www.mastercontrol.com, or call: 800-825-9117 (U.S.); +44 (0) 1256 325 949 (Europe); 81 (3) 5422 6665 (Japan); or +61 (3) 9717 9727 (Australia).

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