Shionogi plans to deploy the QUMAS solution globally to key users across the Clinical and Quality Assurance areas of the business. QUMAS ComplianceSP will enable Shionogi to control Quality and Manufacturing documents such as Standard Operating Procedures, policies and manuals, in accordance with global regulatory requirements.
With the selection of QUMAS ComplianceSP, Shionogi can take advantage of all the capabilities of Microsoft SharePoint 2010, while drawing on the power of ComplianceSP for regulatory compliance management. QUMAS extends the key SharePoint 2010 collaboration capability to ensure full compliance with FDA CFR 21 Part 11 regulatory requirements.
"We have chosen QUMAS because ComplianceSP will provide us with greater control over our quality and manufacturing documents and ultimately create a more productive Shionogi,” said Kohji Takeda, Information Technology General Manager at Shionogi. “We were impressed by the simple intuitive interface and QUMAS’s extensive knowledge of quality requirements and understanding of the SharePoint architecture.”
“I am delighted that Shionogi has selected QUMAS ComplianceSP after an extensive evaluation process involving a number of vendors,” said Kevin O’Leary, CEO QUMAS. “The selection of QUMAS will open up new possibilities for Shionogi to speed up their regulatory compliance processes and delivery of quality products.”
Shionogi has been developing innovative medicines that are essential to people's health for over 130 years.
Headquartered in Osaka, Japan, Shionogi & Co., Ltd. is a major research-driven pharmaceutical company dedicated to placing the highest value on patients. Shionogi’s Research and Development currently targets three therapeutic areas: Infectious Diseases, Pain, and Metabolic Syndrome. The Company has provided such innovative medicines as Crestor and Doripenem, which have been successfully delivered to millions of patients. Shionogi is engaged in new research areas such as allergy and cancer.
QUMAS is the leader in Enterprise Compliance Solutions with more than 250 global customer deployments and two decades of experience helping companies in highly regulated industries. QUMAS is a Gold Microsoft Partner, and provides the QUMAS Compliance Platform on SharePoint 2010, Documentum, Oracle or SQL. For more information, visit www.qumas.com.