Diagnostics manufacturer moving away from paper-based validation to integrated software solution
The Copley Consulting Group, an Infor Gold Level Channel partner, announced that IMMY, a manufacturer of diagnostic tests and reagents, has selected The Copley Consulting Group to implement Infor CloudSuite™ Industrial (CSI) Enterprise Resource Planning (ERP) solution. Copley Consulting will implement their FDA Extended Solution for Infor CSI to replace IMMY’s various systems, while also providing all the functionality needed for them to meet FDA regulatory requirements.
Previously, IMMY was leveraging a paper-based validation system that did not allow for growth while complying with FDA regulations. They were running several systems of record and disparate solutions that led to data being handled multiple times, which caused an increase in errors and risk with FDA compliance. With the move into a new facility in 2016, the company needed an ERP solution that could scale with its growing business requirements.
“With our previous system, we lacked the functionality necessary to automate our FDA validation requirements, which resulted in a time-consuming and costly manual process,” said Sean Bauman, CEO at IMMY. “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.”
“We’re excited to be partnering with IMMY and help them reach their growth objectives,” said William Cary, Vice President of Sales at The Copley Consulting Group. “They are an excellent example of a growing biotech firm which evolved from manual validation to an ERP solution which automates compliance of their GMP risk areas.”
IMMY adds to The Copley Consulting Group’s significant and growing list of FDA regulated clients, which includes Pine Pharmaceuticals, Blickman Industries, and Femasys.
About The Copley Consulting Group
The Copley Consulting Group helps organizations drive business transformation. With nearly 30 years of experience in ERP and business analytics, it is our mission to guide organizations and help them enhance business processes and increase efficiencies in operations. http://copleycg.com