Samsung Bioepis is building a state-of-the-art research and development center in Song-do Incheon, Korea. It is expected that the center will be completed by the end of the year.
Initially, QUMAS ComplianceSP will be deployed in the Research and Development group and will provide users with a secure, structured, and controlled environment for creation, approval, and management of documents from all areas of the organization that have an impact on regulatory submissions, including electronic common technical documents (eCTDs).
QUMAS ComplianceSP is an innovative compliance management solution that combines the power of Microsoft SharePoint 2010 with the proven regulatory domain expertise that QUMAS has gained since 1994 in providing solutions to regulated industries. Combined with a best practice approach for managing documents, processes, people and tasks, ComplianceSP on SharePoint 2010 delivers a unique solution that can manage a wide range of compliance activities on the latest technologies.
"Samsung Bioepis chose QUMAS for a number of reasons," said Steve Dawson, Head of the QUMAS Asia office. "It was clear that our product has the built-in regulatory compliance features they Samsung Bioepis required, such as support for electronic signatures, full lifecycle state management and an extended audit trail. The feedback that Samsung Bioepis received from our reference customers was also extremely positive."
"We are delighted to be involved in this joint venture between our longtime client Biogen Idec and one of our newer clients Samsung Biologics," said Kevin O'Leary, CEO for QUMAS. "Samsung is shooting for the sign-off by international regulatory authorities by the end of the year, and QUMAS will support them throughout the process of achieving this goal."
QUMAS is the leader in Compliance and Quality Management Solutions for the Life Sciences industry, with more than 260 global customer deployments and domain expertise in regulatory compliance since 1994.
QUMAS Quality Management solutions provide Electronic Document Management (SOPs, QA documents), Electronic Process Management (CAPA, Deviation, Change Control, Audit), and GMP Compliance Management. QUMAS Regulatory Affairs solutions provide content and Submission Management including eCTD authoring templates, collaborative review, full integration with leading publishing solutions, scanning, and automated import of paper documents.
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