Fuji Rebio Co., Ltd.

Enhanced quality process control with MasterControl

Process efficiency through digitization of document and education management

Deployment background and challenges

  • Cumbersome, high workload paper-based document management
  • Low readability and searchability due to paper-based document management
  • Cumbersome, high workload management of education record
  • Minimization of compliance risks in export expansion

Selection points

  • Solution with extensive track records in the pharmaceutical and medical device industries that meet a variety of regulatory requirements, including Part 11
  • HOYA Digital Solutions' proposals on implementation schedule and work procedures met the customer needs

Project overview

  • Went live in just over 7 months from the start of the project
  • Selected cloud service
  • On the customer's side, the quality assurance department participated in the project, and established a system operable to a certain extent without relying on the IT department.



Customer feedback (Quality Assurance Department, Fuji Rebio Co., Ltd.)

  • Although the project was carried out mainly by people who were not familiar with IT, we were able to implement the system as planned with the help of HOYA Digital Solutions.
  • The approval route has been streamlined beyond expectation thank to the proposal by HOYA Digital Solutions.
  • The introduction of this system has made it easier for us to approve documents remotely.
  • We believe that we have been able to reduce compliance risks by ensuring the management of electronic media and education that form the basis of documents.

Fuji Rebio Co., Ltd.


Company Name: Fuji Rebio Co., Ltd.
(Miraka Group)
Head Office: Shinjuku Mitsui Building, 2 -1 -1 Nishi-Shinjuku, Shinjuku-ku, Tokyo
Business: Manufacture, sale and import/export of clinical test drugs and test equipment
Website: http://www.fujirebio.co.jp