OREANDA-NEWS. 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.