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09/20/2019 By

IMMY Implements Copley’s FDA Extended Solution

About IMMY

IMMY is a biotech company located in the heart of Norman, OK. Founded in 1979, the organization manufactures, markets, and distributes their own innovative lines of diagnostic tests and reagents. IMMY specifically focuses on mycology, or the study of fungi, which was a virtually forgotten area in the clinical laboratory at the time the company was established. Since that time, IMMY has evolved from a company that filled a need in the market to an organization with a global focus on saving lives through affordable diagnostics.

Business Challenges
  • Move away from paper-based validation system
  • Running several systems of record and disparate solutions
  • Lacked the functionality necessary to automate FDA validation requirements
  • Costly manual process
Benefits
  • Implemented the Copley FDA Extended Solution based on Infor CSI (SyteLine) to replace IMMY’s various systems, while also providing all the functionality needed for them to meet FDA regulatory requirements
  • IMMY now has one system that handles all business requirements, including data integrity as well as documentation for GMP risk areas, leading to an improvement in overall business processes
  • Now have in place an ERP solution that scales with its growing business requirements after their move into a new facility in 2016
Quote

“With Copley, we now have one system that handles all of our business requirements, including our need for data integrity as well as our documentation for GMP risk areas, leading to an improvement in our overall business processes.”
-Sean Bauman, CEO of IMMY

Filed Under: Case Studies Tagged With: copley consulting group, erp solutions, FDA Extended ERP Solution, FDA regulated, immy

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