MasterControl Announces Integration with Datafarm Electronic Submissions Solutions
SALT LAKE CITY – November 28, 2007 – MasterControl Inc. today announced that a connector with Datafarm Inc. solutions is being developed and will be available in early 2008. The MasterControl Connector will help life science companies efficiently and effectively manage their electronic submissions to regulatory agencies.
“Integrating Datafarm’s S-Cubed eCTD application with MasterControl offers our joint customers a seamless transition between document management and electronic submission publishing,” said Paul R. Herd, Vice President, Sales & Marketing of Datafarm Inc. “We believe our integrated applications will provide our customers with a cost effective and intuitive process control solution that combines compliant electronic submission creation and life cycle management.”
“Integrating MasterControl and Datafarm applications gives our shared customers the opportunity to easily prepare submission-ready documents and fully manage the submission lifecycle,” said Michael Bothe, MasterControl vice president of business development.
Datafarm provides out-of-the-box solutions like the S-Cubed eCTD application that simplify the content-submission process for life science companies. To date, Datafarm solutions have been used to submit over 2,000 eCTD submissions to the FDA, Health Canada, EMEA, and other agencies in EU.
With the MasterControl-Datafarm integration, users have the necessary tools to effectively manage submissions documentation from start to finish. MasterControl enables users to create submission-ready documents from the beginning and also control, track, and store their documents in a secure electronic platform. MasterControl also gives users the capability for virtual collaboration, automatic routing, revision control, escalation, and approval of documents. Datafarm tools can be utilized for the final linking and proofing of documents, assembly of the electronic regulatory submission, and management of that submission throughout its lifecycle.
“Datafarm is extremely pleased to be partnering with MasterControl in this effort,” Mr. Herd added. “Our organizational cultures are similar and we both commit to the highest levels of customer satisfaction. With this integration our customers will be able to maximize the values of both our products.”
MasterControl Inc. is a global provider of GxP process and document management software solutions for life science companies. The MasterControl™ suite is easy to use, easy to deploy, easy to validate, and easy to maintain. It incorporates industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl drives down the total cost of ownership and enables customers to extend their investment across the enterprise. Hundreds of companies worldwide use MasterControl for easier compliance, faster validation, and better process management. For more information, visit www.mastercontrol.com or call 800-825-9117.
About Datafarm Inc.
Founded in 1997, Datafarm is a leading provider of electronic document publishing solutions and Regulatory Submissions Services for the life sciences industry. Recognized as one of the world's top eSubmission solutions providers, Datafarm provides its clients with state-of-the-art software technology supported by its Regulatory Services Group. This team of industry specialists offers expert knowledge of regulatory, clinical, CMC, non-clinical and IT issues, and provides direction on the drug development process with focus on regulatory submissions.
Meeting the needs of large and small companies worldwide, Datafarm has already helped an extensive range of customers with proven products and services. To date, the company has been involved in over 1,000 submissions to multiple agencies and over 60 installations.
Datafarm focuses on functional business needs and provides technical solutions appropriate to those needs by applying regulatory agency requirements, delivering significant time and resource savings.