Case Study: Fujirebio Diagnostics, USA

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Fujirebio Diagnostics, USA

This chapter was originally published in Digital Transformation

Nominated by Wonderware, India

Fujirebio Diagnostics, Inc. (FDI) is a premier diagnostics company and the industry leader in biomarker assays. We specialize in the clinical development, manufacturing, and commercialization of in-vitro diagnostic products for the management of human disease states with an emphasis in oncology.

FDI personnel identified a major opportunity to save time and paper by automating the acquisition of equipment data and generating electronic reports for review and approval.

With direction from FDI’s executive management driving a strategic “Electronic Initiative” as a vision for future systems, a project team was assembled to define and implement a system capable of addressing a complex set of user requirements to streamline our existing paper based GMP record system and manual data logging process with an electronic system.

A comprehensive Project Management Plan was then developed to drive the ensuing project to completion by incorporating FDI’s System Development Life Cycle (SDLC) procedures to ensure that all deliverables were generated and the project completed in accordance with company requirements to comply with FDA regulations.

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