San Diego, CA - December 1, 2005 - At the DIA eCTD meeting, QUMAS, the leading developer of enterprise compliance, governance and risk management solutions, and Datafarm, Inc., the global leader in electronic regulatory submissions solutions, today announced a product integration effort that will benefit life science companies seeking drug approval. The integrated solution combines document management, document approval and submission compilation with the systems needed to fulfill complex regulatory compliance mandates. Integration was completed by Datafarm using the QUMAS Web Services SDK. Testing and certification was performed jointly by QUMAS and Datafarm.
The integrated offering consists of QUMAS Compliance Suite™ coupled with Datafarm's eCTDBuilder®, a solution that assists sponsor organizations in preparing their marketing applications to regulatory agencies around the world in electronic format using the electronic Common Technical Document (eCTD) specifications. eCTDBuilder® has built-in intelligence that makes the creation of eCTD submissions seamless, reliable, and of high quality through the life cycle of a new drug application.
The QUMAS QUMAS Compliance Suite is an integrated compliance solution that ensures organizations remain in a state of constant compliance while covering multiple regulations with a single solution. Designed to allow organizations to initiate and maintain a sustainable compliance program, the QUMAS solution brings together the multiple disciplines of policy management, process enforcement, monitoring and reporting into an integrated solution. QCompliance is architected to streamline, organize, and automate compliance-related activities on an enterprise-wide level. Additionally QCompliance is highly configurable, lending itself to handling the compliance requirements of existing and future regulations without coding.
Datafarm's eCTDBuilder provides a one-stop solution for eSubmission that abstracts the complexity of XML, submission contents and directory structure of the eCTD specifications. It builds the XML backbone that constitutes the electronic CTD without the need for the user to understand XML and eCTD Document Type Definition (DTD). eCTDBuilder generates compliant submissions using ICH and Regional agency specifications and has the capability to create eCTD submissions for the FDA in US, EMEA and other EU countries in Europe, MHLW in Japan, Health Canada in Canada and the FDA in Taiwan.
QUMAS integration with Datafarm's eCTDBuilder 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 21 CFR Part 11 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 DIA eCTD meeting, QUMAS and Datafarm representatives will be available to discuss the solution.
"The combined QUMAS and Datafarm closed looped solution ensures sustainable compliance, mitigates risk, and manages ongoing costs," said Paul Hands, CEO of QUMAS. "This holistic solution combines policy management, process enforcement, reporting, monitoring and electronic submissions, and will help life sciences firms bring products to market faster," stated Hands.
"The QUMAS QUMAS Compliance Suite complements Datafarm submission solutions by enabling our customers to efficiently manage and control their electronic documents that govern how documents are created, reviewed, approved, and submitted," said Shylendra Kumar, Founder and President of Datafarm. "The solution combines the strengths of each product and is critical to life sciences customers," added Kumar.
Datafarm is a leading solutions provider of Electronic Document Publishing and Regulatory Submissions Services for the Life Sciences Industry. Datafarm augments the drug development process by providing both custom and off-the-shelf regulatory compliant solutions worldwide. Datafarm solutions, delivered through its products and professional services, maximize the quality of publishing and efficiency of document life-cycle management. To date, Datafarm has assisted sponsor organizations with over 300 electronic submissions, submitted to the FDA, Health Canada, EMEA and Japan regulatory authorities.
Datafarm solutions reduce the challenges facing Life Sciences companies by automating the regulatory submissions process. Datafarm products have assisted its clients in producing high-quality, agency-compliant e-Submission-ready documents. The impact of these timely solutions has been translated into improved internal workflow efficiencies, lower production costs and reduced time to submission, saving its clients both money and precious time to regulatory approval.
Datafarm is a privately owned company with headquarters in Marlborough, MA, and regional offices in California, India, UK, and Japan.
With over a decade of experience, QUMAS provides a proven enterprise compliance management solution 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.
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