Cork, Ireland – October 11, 2012
QUMAS today announced that Emergent BioSolutions Inc. (NYSE: EBS), a global biopharmaceutical company based in Maryland, USA, has selected the QUMAS Compliance Platform to manage regulatory documents and quality processes across the organization.
"QUMAS met all of Emergent BioSolution's selection criteria as we evaluated quality management solutions to replace our legacy system," said Denise Landry, Chief Quality Officer of Emergent BioSolutions. “QUMAS has a demonstrated track record of service to the biopharmaceutical industry and we look forward to benefiting from their quality solutions and experience."
In the initial phase of the project, QUMAS DocCompliance™ and QUMAS Compliance Unity™ will be deployed to a broad range of Emergent users as a replacement to their current system, to enable them to continue to manage quality and regulatory content as it is created, reviewed, approved, consumed, distributed, and retired in compliance with FDA 21 CFR Part 11 requirements.
“QUMAS is delighted to add Emergent BioSolutions to our growing list of clients," said Kevin O'Leary, CEO QUMAS. "It was evident from the outset of our engagement that we are the right fit for Emergent, and we’re looking forward to continuing to deploy successfully across the company.”
QUMAS is the leader in Compliance and Quality Management Solutions for the Life Sciences industry, with more than 270 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. The QUMAS Compliance Platform is available on Microsoft SharePoint 2010, Oracle, Microsoft SQL Server and EMC Documentum.