GN ReSound Facilitates US Food and Drug Administration Compliance with Streamlined, Global, Product Data Lifecycle Management
 
 

GN ReSound Facilitates US Food and Drug Administration Compliance with Streamlined, Global, Product Data Lifecycle Management

  • Oracle Customer:  GN ReSound
    Location:  Copenhagen, Denmark
    Industry:  Healthcare
    Employees:  3,000
    Annual Revenue:  $500 Million to $1 Billion

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GN ReSound, part of the GN ReSound Group, is one of the world’s largest manufacturers of hearing instruments and diagnostic audiological instrumentation. The primary goal of the company, which has subsidiaries in 23 countries, is to improve the quality of life for people with hearing loss.

As a medical device manufacturer, GN ReSound must meet stringent US Food and Drug Administration (FDA) product data control regulations. After several international mergers and acquisitions, GN ReSound also needed to align and streamline its product data management processes, so it could share product information worldwide and assure FDA compliance.

To achieve these goals, the company implemented Oracle’s Agile Product Collaboration. It consolidated all product data and relevant documentation in a central repository, which acts as a single point of truth for all offices and allows the company to meet FDA regulatory requirements. It also provides a foundation for a global, change-control processes and supports master data for the manufacturing, budgeting, and auditing of product compliance.

 
 

 
 

Challenges

A word from GN ReSound

  • "Using Oracle’s Agile Product Collaboration to manage the product data for our hearing instruments and related accessories, we ensure high data quality, can effectively track revision histories, and we have never lost any data or information stored in the system. This is amazing and fantastic!" – Vibeke Nyrop, Product Data Management Manager, GN ReSound

  • Align and streamline product data management processes across several different hearing instrument companies recently acquired by GN ReSound, using different document control systems and data structures
  • Enhance product-lifecycle management for the company’s hearing aid brands and diagnostic instruments by consolidating all product data and documentation into a single repository
  • Create a globally accessible product information and documentation environment that enables information sharing and international collaboration between the company’s hearing-instrument product design and manufacturing units, customers, and a growing number of external manufacturing suppliers
  • Streamline compliance with FDA regulations related to medical devices and manufacturers’ quality systems

Solutions

Oracle Product and Services

  • Implemented Agile Product Collaboration as the foundation for the company’s new, global, product-information and documentation environment, which provides a complete overview of all audiological products and parts
  • Streamlined and unified the product-data lifecycle management process in a single repository and achieved consistent, high-quality data through a full of view of all product components, parts, and documentation
  • Simplified manufacturing, budgeting, and auditing of product compliance by using consolidated product data as the master data for these processes
  • Ensured automatic compliance with FDA 21 CFR part 11 regulations by creating appropriate control data for all products and introducing electronic signature capabilities to documentation
  • Implemented a device-master-record package containing all product-related data and documentation, such as product specifications, regulatory requirements, product bill of materials, and marketing materials related to each auditory product family to provide regulators with proof of compliance
  • Used electronic product documentation to eliminate the possibility of important product change information not being sent or getting lost in the mail
  • Improved collaboration with external suppliers by involving them in the early stages of product development processes, providing them access to latest product data and documentation, and allowing them to comment on changes
  • Improved customer service for hearing aid shops, hospitals, and distributors with easy access to reliable product information within the global product information and documentation environment
  • Enhanced stock management through better visibility into a possible need for terminated parts elsewhere in the international manufacturing organization
  • Supported changes in business processes and organization by making continuous changes to the configuration of Agile Product Collaboration