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Industry leaders combine best-of-breed solutions to improve the quality of clinical trials and regulatory compliance
Tokyo, Apr 19, 2012 - (JCN Newswire) - 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 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 www.mastercontrol.com.
About Fujitsu Limited
Fujitsu is a leading provider of information and communication technology (ICT)-based business solutions for the global marketplace. With approximately 170,000 employees supporting customers in over 100 countries, Fujitsu combines a worldwide corps of systems and services experts with highly reliable computing and communications products and advanced microelectronics to deliver added value to customers. Headquartered in Tokyo, 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 visit www.fujitsu.com.
Source: Fujitsu Limited
Contact:
Copyright 2011 JCN Newswire. All rights reserved. www.japancorp.net
Tokyo, Apr 19, 2012 - (JCN Newswire) - 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 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 www.mastercontrol.com.
About Fujitsu Limited
Fujitsu is a leading provider of information and communication technology (ICT)-based business solutions for the global marketplace. With approximately 170,000 employees supporting customers in over 100 countries, Fujitsu combines a worldwide corps of systems and services experts with highly reliable computing and communications products and advanced microelectronics to deliver added value to customers. Headquartered in Tokyo, 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 visit www.fujitsu.com.
Source: Fujitsu Limited
Contact:
Fujitsu Limited Public and Investor Relations www.fujitsu.com/global/news/contacts/ +81-3-3215-5259
Copyright 2011 JCN Newswire. All rights reserved. www.japancorp.net
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