Global Pharma Management

Hitachi, Ltd. and NextDocs Corporation today announced their newly formed partnership in document management solutions for pharmaceutical manufacturers.

Specifically, NextDocs and Hitachi will provide NextDocs Document Management System to the life sciences companies in Japan. NextDocs will provide software licenses and solutions to customers and Hitachi will provide supporting services including business consulting, system integration, training, operation, and validation support for drug regulations. NextDocs will provide necessary support to Hitachi sales, marketing and technical personnel.

Many pharmaceutical companies accelerate globalization of research and development and they must submit applications and receive approval of new drug candidates in the Japan-Europe-U.S. trilateral framework. NextDocs Document Management System is an out-of-the-box software solution which makes it easier to manage trilateral common application documents. It is also compliant with FDA 21 CFR PART 11, which deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. NextDocs Document Management System runs on Microsoft Office SharePoint Server 2007. Customers are able to reduce costs for program development and shorten times for implementation by using NextDocs standard functions and the content management functions of Microsoft SharePoint Server 2007. NextDocs Document Management System has been adopted by over 30 pharmaceutical and medical device companies around the world, and NextDocs continues to gain market share.

Hitachi delivers total solutions for all business processes of pharmaceutical manufacturers such as research and development, production, logistics and sales, and Hitachi has considerable experience especially in regulation consulting, business process consulting, and system implementation.

This partnership is part of Hitachi’s ongoing plan to strengthen solutions in the area of pharmaceutical research and development.