Managing quality across pharma organisation

Shionogi & Co., Ltd., a leading Japanese pharmaceutical company, has selected QUMAS ComplianceSP™ software to manage its quality content.

Shionogi plans to deploy this 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 this selection 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.”