Murata Manufacturing Co., Ltd.

Adopted MasterControl as a QMS that can withstand audits in the medical device division.

Improving process efficiency through digitalization of QMS

Background and challenges

  • Complicated, high-workload, paper-based document management
  • Reviewers are often unavailable and reviews take time.
  • Want to minimize compliance risks when considering overseas expansion
  • Necessary to establish a QMS that can withstand audits by FDA, etc.

 

Selection points

  • It has been used in public organizations such as FDA.
  • Validation can be performed to meet regulatory requirements such as 21 CFR 11.
  • The specifications can be customized to some extent to fit the user company's processes, and operations such as setting changes can be done in-house.

Project overview

  • Implementation scope: documentation, education, BOM, change management, CAPA, and deviation, change, and non-conforming product management.
  • Go-live in about 8 months from project start
  • Implementation method focused on training to enable a certain level of self-operation after go-live

 

Customer feedback

  • Even those in charge with little knowledge of IT can now set up Master Control after receiving training from HOYA Digital Solutions.
  • Previously the training management for work instructions was complicated. Now it is simpler and more reliable as an automatic training notice is given upon issuance of new work instructions.
  • Paper-based document distribution and storage are no longer needed, reducing the workload of document management staff.
  • The capability to parallel review documents led to shorter review time spent.

 村田 事例

 

 

 

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Murata Manufacturing Co., Ltd.

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Company Name: Murata Manufacturing Co., Ltd.
Head Office: 10-1, Higashikotari 1-chome, Nagaokakyo-shi, Kyoto
Business: R & D, production and sales of electronic devices

WEB site:

Head Office 

https://www.murata.com/ja-jp

Medical and healthcare equipment 

https://medical.murata.com/