QUMAS DocCompliance™ and Datafarm S-Cubed® integrate to provide customers with an end to end solution for the creation and management of Electronic Common Technical Documents (eCTD), Non-eCTD Electronic Submissions and Paper Submissions to global regulatory agencies.
Jersey City, NJ and Marlborough, MA -- QUMAS, a leading provider of Regulatory Compliance Solutions and Datafarm, a leading provider of high performance electronic Regulatory Submission Solutions, today announced an integration between QUMAS DocCompliance™ and Datafarm S-Cubed® , providing customers with an end to end solution for the creation and management of Electronic Common Technical Documents (eCTD), Non-eCTD Electronic Submissions and Paper Submissions to global regulatory agencies.
George Waidell, Director of Product Strategy at Datafarm said, "Datafarm's expertise is in the compilation and publishing of eSubmissions to global regulatory agencies. QUMAS DocCompliance plays a vital role in ensuring that customers effectively create and manage the submission source documents. When integrated with S-Cubed, clients benefit from an end to end, best in class regulatory submissions solution."
QUMAS and Datafarm clients can effectively manage the entire lifecycle of Electronic Submissions seamlessly by combining documents from DocCompliance in S-Cubed for submission assembly and validation, ensuring compliance with the global regulatory agencies guidelines and specifications for compiling and publishing submissions.
"The QUMAS integration with Datafarm will enable our clients to get faster regulatory approval with accurate submissions, which can also be reused for submissions to many different regulatory bodies," said Caoimhe Kiely, VP Marketing at QUMAS. "This is the key to a successful partnership, enabling our clients to get their products to market faster."
QUMAS is the leader in Regulatory Compliance Solutions with more than 250 customer deployments and over a decade of experience helping companies in highly regulated industries provide a proactive regulatory defense. QUMAS solutions for life sciences are designed to achieve compliance with industry and government standards for 21 CFR Part 11, cGxP, Quality, R&D, Regulatory Affairs and Clinical Operations. For more information visit http://www.qumas.com
About Datafarm, Inc.
Established in 1997, Datafarm is a world leader in high performance electronic regulatory submission solutions for the Life Sciences industry. Datafarm's open, modular technologies and professional services experts enable Life Sciences companies to meet the strict standards of regulatory authorities across the world, helping them achieve quality, accuracy, and compliance to efficiently deliver regulatory reports and submissions. For more information visit http://www.datafarminc.com
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