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.”

Partnership with leading Japanese life science company!

QUMAS has just announced a partnership agreement with CTC Laboratory System Corporation (CTCLS), who will distribute, implement and support the QUMAS Compliance Platform in Asia.

Katsuya Mizuno – Deputy General Manager Strategic Planning & Business Development, CTC LS, John Near - Irish Ambassador to Japan, Hideki Negishi – CEO, CTC LS, Éamon Gilmore - Tánaiste Éireann, Warren Perry – Compliance Consultant, QUMAS, Yusuke Tanabe – General Manager Strategic Planning & Business Development Department, CTC LS, Eddie Hughes – Director Japan, Enterprise Ireland

As a unique member of ITOCHU Techno-Solutions Corporation (CTC), CTCLS has evolved into one of Japan's leading solution providers that specialize in the integration of R&D support systems for life sciences companies. With incomparable end-to-end solution capability, CTCLS serves pharmaceutical, chemical and food manufacturers, as well as universities and public offices. It offers a wide range of products and services that cover every stage of R & D activities to achieve a high level of customer satisfaction and trust.

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 (SOPs etc) and process management (CAPAs etc), presenting these through a unified user interface, with integrated learning management, and consolidated reporting and dashboarding, all driving regulatory compliance and ultimately delivering better business performance.

“We are very excited by this partnership with CTCLS, which further extends our activities in Asia,” said Kevin O’Leary, CEO for QUMAS. “CTCLS has a great reputation, and a wealth of industry expertise. I am confident that they will continue to represent the QUMAS Compliance Platform as the preeminent solution for compliance requirements.”

Having already signed a major contract with the leading Japanese pharmaceutical company, QUMAS and CTCLS formally announced their partnership at an Enterprise Ireland Trade Mission in Japan on October 11^th, 2011, which was attended by the Irish Tánaiste Éamon Gilmore (See picture above!).

The QUMAS Compliance Platform delivers control across the business, ensuring compliance mandates are not only adhered to but ultimately deliver tangible business performance improvements across the organization.
The company is the leader in Compliance Solutions with more than 260 global customer deployments and two decades of experience in highly regulated industries.
It is also a Gold Microsoft Partner, and provides the QUMAS Compliance Platform on SharePoint 2010, Documentum, Oracle or SQL.

"Stellar results!"

QUMAS showed ongoing growth and profitability last year. QUMAS signed up 24 new customers for their compliance solutions including Tufts University, Sanquin Blood Supply Foundation, Siena Biotech, and several Fortune 100 companies in the Automotive, Banking, Energy, Insurance, and Technology sectors.

Kevin O'LearyKen Hayward

“It is always worth celebrating when a company grows as strongly as QUMAS did in 2009. Not only because of the number of new clients, but also because our core software sales grew by more than 20%. And all of this at a time when markets were severely under pressure,” said Kevin O’Leary, CEO. “Our profitability picture is a credit to an outstanding team who continue to focus on delivering great products to our rapidly growing client base. We are looking forward to a strong 2010 where we anticipate strong new client adoption across a broad range of markets.”

The company continued to invest heavily in R&D in 2009. New products launched last year included MyQUMAS 3.1, QUMAS DocCompliance 4.2, QUMAS ComplianceUnity and the QUMAS Biotechnology Package, a complete, web-based eDMS solution for biotechnology companies preparing for regulatory submissions that is delivered pre-configured and ready to use.

“Last year we focused on making our products easier to use and provided customers with the capability to configure dashboards on compliance activities across business units,” stated Ken Hayward, Chief Technology Officer of QUMAS. “In 2010 we will be focusing on extending our line of packaged solutions to help firms get up and running quickly with best-of-breed compliance solutions.”

Best managed company

QUMAS, leading provider of Compliance Solutions to highly regulated companies, has won the Deloitte Best Managed Companies Award.

At a Gala Awards Symposium held on Friday 5th March at the Burlington Hotel in Dublin and attended by the Taoiseach, Mr Brian Cowen T.D., QUMAS was named as one of Ireland’s Best Managed Companies by Deloitte. The Deloitte Best Managed Companies awards program, in association with Bank of Scotland (Ireland), was developed to recognize Irish companies operating at the highest levels of business performance. The program identifies the best managed companies through an evaluation process that extends far beyond financial results.

“We are delighted to receive this accolade from Deloitte”, said Kevin O’Leary, CEO Qumas. “As a profitable and growing indigenous Irish company, we are very proud of our success and growth, particularly in these challenging times. This achievement recognizes the commitment and dedication of the QUMAS management team to making the company a global success”.

As Qumas continues to confirm its clear dominance in the Regulatory Compliance marketplace, it’s thought leadership and world class solutions continue to attract repeat business from its client base as well as a broad range of new clients from many regulated sectors. An Irish company, it operates at a global level, with over 95% of its revenues coming from outside the domestic market.

Picture shows Taoiseach (Head of Government Ireland) Brian Cowan, left with Kevin O'Leary, Qumas.