Samsung Biologics Selects QUMAS Platform
QUMAS has announced that it has been selected by Samsung Biologics to provide an integrated regulatory compliance platform. Samsung Biologics, which forms part of the Samsung Group, was established in February 2011 and aims to be a leader in the biopharmaceutical manufacturing industry, offering world-class mammalian cell-based cGMP contract manufacturing services.
Samsung Biologics has started construction of a new manufacturing facility near Seoul and it is anticipated that the facility will be operational by January 2013.
A proven leader in the regulatory compliance space, the QUMAS Compliance Platform will be rolled out to Samsung Biologics, initially across Quality Assurance in Manufacturing to drive quality and regulatory compliance from day one.
The QUMAS Compliance Platform is a closed-loop compliance solution that combines all of the elements of a cohesive regulatory compliance program, onto one platform.
It delivers comprehensive capabilities around document management (Policies, SOPs etc.) and process management (CAPAs, Deviations, Audit etc.), presenting these through a unified user interface, with integrated learning management, and consolidated reporting and dash boarding, all driving regulatory compliance and ultimately delivering better business performance.
For the first phase of the engagement with Samsung Biologics, the QUMAS Compliance Platform will provide the Quality Assurance Package, for the control of all manufacturing documents, including the creation, lifecycle management and secure, audited control of all relevant content and reports, in compliance with 21 CFR Part 11.
Greg Tewalt, head of QA, Vice president of Samsung Biologics, stated, "We are extremely pleased with the knowledge and professionalism of the QUMAS staff as well as the QUMAS Compliance Platform, and we are looking forward to a productive partnership."
"We are delighted to be selected by Samsung Biologics," said Kevin O'Leary, CEO for QUMAS. "Samsung Biologics have recognized our commitment to doing business in Asia, our proven compliance expertise, and our ability to deliver (with our partners Cegedim) best practice regulatory compliance technology on one integrated platform."
QUMAS has also recently announced a partnership agreement with CTC Laboratory Corporation (CTCLS). CTCLS will distribute, implement and support the QUMAS Compliance Platform in Asia.