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A real-world look at digital transformation.

Nonin Easily Handles Three-year FDA Audit Just Three Weeks After Implementing Microsoft Dynamics With FDA Toolkit

By Ted Root | February 22, 2018

Can you imagine facing an FDA audit just three weeks after implementing Microsoft Dynamics? That’s exactly what happened to Life Sciences company Nonin.

Nonin is a medical device manufacturer and the inventor of the first fingertip pulse oximeter, still in worldwide use today. Nonin covers a vast amount of markets in healthcare, including hospitals, emergency, VA, government, military, veterinary, dental, homecare, OEM modules and integrated kit systems, making its business management needs complex.

In the past, Nonin utilized a financial package integrated to a separate manufacturing solution. Because of customer needs for EDI communication, healthcare exchanges, and supplier commerce, the products were no longer meeting its needs. Noncompliance fees for EDI from distribution partners were starting to add up to thousands of dollars a month. To prepare for future medical device industry standards from the FDA, GUIDID, Device Marking and other global requirements for device serialization and registrations, Nonin knew it was time to make a move. 

Additionally, Nonin was running a separate system for its B-to-B and B-to-C ecommerce, as well as several systems for product lifecycle management, and needed a single, integrated system for both.

Over 2 Years and 1,200 Business Requirements

Fullscope provided an onsite analysis and requirements building session, and over 1,200 business requirements were identified. “To summarize these requirements, we needed a solution which would give our customers and internal users a better experience, and grow with us to support our business needs,” says Rick Trask, Director of IT for Nonin. 

“We probably spent about two-and-a-half years evaluating systems,” says Trask. “We investigated many different types of systems. My experience over the last 20+ years has been with JD Edwards One World, SAP, and Oracle. These are all good systems, but we were looking for something that was a better fit for our business,” continues Trask. “SAP and Oracle are overkill for our industry size and space—it takes an army to run them. More nimble companies like ours need a flexible, proven platform like Microsoft Dynamics.” The Nonin team attended user group meetings, Microsoft briefing centers, and spoke with several Microsoft Dynamics customers to ensure that they were making the right decision.

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Three-year FDA Audit

Three weeks after implementing Dynamics with Fullscope’s EDGE for Operations, which addresses critical quality and regulatory compliance requirements for FDA-regulated industries, OSHA, EFSA, EMA, HC, and more, Nonin faced an FDA audit. “It wasn’t the regular audit, it was the three-year audit,” laughs Trask. “Luckily, we could handle the audit because we implemented Dynamics, along with EDGE for Operations, and OnShore Technology’s Validation toolkit,” says Trask. “With EDGE for Operations, we can now manage our CAPA non-conformance incidents.”

To learn more about Nonin and the benefits its experiencing from implementing Microsoft Dynamics, read the full success story or watch the videos

About Ted Root

Ted has over 10 years of experience helping mid-market to large organizations become more effective and efficient through digital transformation.

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