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At the DIA eCTD meeting, QUMAS, developer of enterprise compliance, governance and risk management solutions, and Datafarm, Inc., provider of electronic regulatory submissions solutions, 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' QCompliance 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 QCompliance 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 QCompliance 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.
02.12.2005, QUMAS
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