Fujirebio Diagnostics, Inc.

Fujirebio Diagnostics implements an equipment monitoring system based on Wonderware Skelta BPM to ensure compliance for extensive reporting and documentation requirements from regulatory authorities.​

  • Josh Zimmer, Quality Engineer Fujirebio Diagnostics, Inc.

    The largest benefit of the equipment monitoring system is that we are logging automatically now rather than manually, so it’s saving us about 1,100 man hours per year.

  • Goals

    • To replace an existing paper-based GMP record system and manual process with an electronic monitoring system
  • Challenges

    • A significant amount of time is spent each day manually reviewing reports
    • The existing paper-based system was timeconsuming and vulnerable to reporting errors
    • A new system must enable the company to remain in compliance with federal regulation
  • Results

    • The company’s Electronic Initiative helps produce 75 million tests that are distributed throughout the world
    • The solution is completely paperless and provides electronic record collection with electronic signatures while maintaining 21 CFR compliance and ISO 9001 and 13485 certification
    • The equipment monitoring system saves about 1,100 man hours per year
    • The tasks related to manually logging equipment parameters and reviewing paper logs and charts is eliminated and has reduced data reviewing time from 15+ hours to just minutes
    • Electronic monitoring saves 2/3 of time, or about 10 hours per month in quality assurance