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Fujitsu and MasterControl Announce Strategic Partnership

Industry leaders combine best-of-breed solutions to improve the quality of clinical trials and regulatory compliance

Fujitsu Limited,MasterControl Inc.

Tokyo, April 19, 2012

Fujitsu announced today that it has entered into a reseller agreement with MasterControl Inc., a global provider of quality management software (QMS) solutions, in order to strengthen its capabilities as a solutions provider in the life sciences field.

From April 19, Fujitsu will begin offering all of MasterControl's eight products to global manufacturers of pharmaceuticals and healthcare devices, while commencing consulting and installation support services related to QMS.

Within the life sciences field, greater emphasis has been placed on the safety of pharmaceuticals and healthcare devices worldwide in recent years as the demand for compliance continues to reach unprecedented levels. This is especially true in the pharmaceutical field, in which the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has become the standard in Japan, the U.S. and Europe. Companies in those regions are fervently implementing more comprehensive quality management systems such as risk management and global quality assurance frameworks.

For many years, Fujitsu has offered business systems to support research and development in the life sciences field, holding a top share in terms of total deployment. Meanwhile, MasterControl provides software to support digitization of QMS for over 550 customers. The U.S. Food and Drug Administration (FDA), which oversees pharmaceutical and medical device manufacturers uses,the MasterControl product. Nearly half of the top 20 global pharmaceutical companies also use MasterControl.

Under the agreement, both companies will bring to bear their respective track records and know-how to provide solutions in the life sciences field. This will enable total QMS solutions that integrate with customers' business systems, responding to each customer's regulations and strengthening their global competitiveness.

Going forward, Fujitsu and MasterControl will strengthen their alliance and develop functions to integrate both companies' solutions, while delivering more robust cloud-based services and offering new service models aimed at improving product quality in the life science field in Europe and America. Specifically, in partnership with DDworks21(1), Fujitsu's GCP(2) Process Management system that hold the top market share in Japan, the alliance will enable a GCP risk management solution geared toward global clinical trials.

Comment from Jonathan Beckstrand, CEO for MasterControl

We are very excited to partner with such a strong regional and global IT leader. This partnership and product integration, along with the combined years of experience of MasterControl and Fujitsu, will give pharmaceutical customers a major advantage in meeting the ever-increasing global regulatory challenges.

Comment from Taketoshi Ohba, General Manager, Fujitsu Life Science Industry Sales Division, Manufacturing Industry Business Unit

We are confident that this strategic partnership will help us continue to build Fujitsu's strong global presence and further enhance the technical innovations that both of our organizations provide to the life science industry.

  • [1] DDworks21

    the leading software solution for clinical trial quality and regulatory compliance in Japan.

  • [2] GCP

    "Good Clinical Practice" refers to standards for carrying out clinical trials.

About Fujitsu

Fujitsu is the leading Japanese information and communication technology (ICT) company offering a full range of technology products, solutions and services. Over 170,000 Fujitsu people support customers in more than 100 countries. We use our experience and the power of ICT to shape the future of society with our customers. Fujitsu Limited (TSE:6702) reported consolidated revenues of 4.5 trillion yen (US$55 billion) for the fiscal year ended March 31, 2011. For more information, please see

About MasterControl

MasterControl Inc. produces software solutions that enable companies doing business in regulatory environments to get their products to market faster, while reducing overall costs and increasing internal efficiency. MasterControl securely manages a company's critical information throughout the entire product lifecycle. MasterControl software is known for being easy to implement, easy to validate, and easy to use. MasterControl solutions include quality management, document management, document control, product lifecycle management, audit management, training management, bill of materials, supplier management, submission documents management, clinical trial management, and more. Supported by a comprehensive array of services based on industry best practices, MasterControl provides customers with a complete information management solution across the entire enterprise. For more information about MasterControl, visit

Press Contacts

Public and Investor Relations Division

Company:Fujitsu Limited

Press Contacts

Robyn Barnes

Phone: Phone: (801) 942-4000 x1714
E-mail: E-mail:
Company:MasterControl Inc.

All other company or product names mentioned herein are trademarks or registered trademarks of their respective owners. Information provided in this press release is accurate at time of publication and is subject to change without advance notice.

Date: 19 April, 2012
City: Tokyo
Company: Fujitsu Limited, MasterControl Inc., , , , , , , , ,