CASE STUDY

Fujirebio Diagnostics’
MES Transformation with POMS

Fujirebio Diagnostics’ MES Transformation with POMS
How a pharma-first MES enabled scalable, compliant manufacturing operations

Fujirebio Diagnostics is a global leader in the development and manufacture of in vitro diagnostic test kits, including oncology-focused products used in life-critical applications.

With manufacturing operations spanning North America, Europe, and Asia, Fujirebio supports both internal production and third-party manufacturing relationships while maintaining strict regulatory standards.

Continuous improvement and digital transformation are core to Fujirebio’s operational philosophy - driving the organization to modernize its manufacturing execution processes.

POMS provided a system that fit how Fujirebio manufactures - rather than forcing teams to adapt to generic software.

Fujirebio selected POMS for its deep expertise in life sciences manufacturing and practical approach to MES deployment.

  • Pharma-First MES software; designed specifically for regulated environments.
  • Native integration with manufacturing equipment; eliminating manual transcription.
  • Strong collaboration with Fujirebio’s IT team; supporting long-term success.
  • An operator-friendly interface; minimizing change resistance.
  • A clear path to scale; as manufacturing needs evolved.

The Challenge: Scaling Paper in a Regulated Environment

Prior to MES adoption, many Fujirebio departments relied entirely on paper-based manufacturing records. While familiar, paper systems increasingly became a barrier as operations scaled.

QA teams were required to manually review every record before release, creating bottlenecks and delaying production timelines. Fujirebio recognized an opportunity to prevent errors at the source - rather than detect them after the fact.

Key challenges included:

  • Manual transcription errors and incorrect entries; introducing avoidable quality risks.
  • Missed signatures and incomplete records; increasing review effort.
  • Extensive time spent on QA and Quality reviews; slowing batch release.
  • Limited safeguards to prevent errors; relying on detection instead of prevention.

Phased Deployment Approach

Implementation began in 2018 with a phased rollout strategy.


POMS worked closely with Fujirebio to:

✔️ Clearly define deployment phases and objectives; aligned to operational priorities

✔️ Provide on-site and virtual training; for manufacturing and quality teams

✔️ Support operators transitioning from paper to digital workflows; through testing and hands-on guidance

✔️ Align terminology; between technical MES concepts and shop-floor processes

Change management proved critical. While some operators were initially hesitant to move away from paper, training, testing, and ongoing support helped drive adoption.

Over time, Fujirebio expanded MES usage beyond the initial deployment to 13 departments, upgrading to the Aquila MES suite and standardizing execution across operations.

Operational Impact

The impact of POMS was felt across manufacturing, QA, and IT:


✔️ 25–30% reduction in manual errors; through enforced, electronic execution

✔️ Significant decrease in review cycle times; enabled by Review by Exception (RBE)

✔️ Improved documentation accuracy and consistency; strengthening audit readiness

✔️ Reduced operator decision errors; via guided workflows

✔️ Faster, more reliable material transfers; improving end-to-end flow

By embedding quality into execution, POMS allowed Fujirebio teams to focus on producing high-quality diagnostic products - rather than managing paperwork.

A Foundation for the Future

Today, POMS is a foundational system within Fujirebio’s manufacturing operations. With a scalable, compliant digital backbone in place, Fujirebio is well-positioned to support future growth, global expansion, and evolving regulatory expectations.


Customer Quotes



“By moving from paper to Aquila MES, we significantly reduced manual errors and shortened our review cycles. Review by Exception helped our quality teams focus on what truly matters, while giving manufacturing greater confidence in the data captured at the point of execution.”


Senior Manufacturing Leader, Fujirebio Diagnostics

“The POMS Consultants understood our manufacturing environment and worked closely with our IT, quality, and operations teams throughout the implementation. Their structured approach and life sciences expertise made the transition from paper to digital execution manageable and set us up for long-term success.”


MES Program Lead, Fujirebio Diagnostics

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