Medical device manufacturer turned to Copley Consulting for FDA Extended ERP solution for consolidated quality control
HemoSonics, a manufacturer of diagnostic platforms for critical bleeding, has selected The Copley Consulting Group’s FDA Extended Solution based on the Infor CloudSuite™ Industrial (CSI) Enterprise Resource Planning (ERP) application. Copley Consulting will implement the new ERP system, which will replace HemoSonics’ manual systems and processes, providing all the functionality needed for them to meet FDA regulatory requirements and support their aggressive growth goals.
- Move away from manual processes: Copley Consulting is helping HemoSonics migrate away from a homegrown solution that combined spreadsheets and manual processes.
- Support across US and Europe: Having gained approval for their product internationally, and pending approval in the US, the company was moving into full production and looked to Copley Consulting for an ERP system that could keep up with company growth and compliance mandates, while reducing regulatory risk.
- Mixed load manufacturing: With a mixed load manufacturing environment, including discrete manufacturing for the actual instrument and process-based for the cartridges, the ERP system needed to be able to handle all elements of the manufacturing process.
- Automate service and product re-ordering: The FDA Extended Solution also allows HemoSonics to know their service footprint, such as tracking product warranties, as well as allow their customers to reorder cartridges on an ongoing basis in order to perform critical blood tests.
“With our existing processes, we lacked a consolidated system that could automate our manufacturing process,” said Steve Erwine, CFO at HemoSonics. “With Copley, we now have the system and processes in place to address FDA regulatory mandates and CE requirements, as well as satisfying financial compliance requirements. The new system includes mission-critical features such as serial lot traceability to track all components of our products through the manufacturing lifecycle, and to meet FDA software validation requirements, thus ensuring quality control.”
“HemoSonics is a great example of a FDA regulated firm with complex manufacturing requirements. They need to track multiple processes across different continents in order to meet their growth objectives and remain compliant with regulations,” said William Cary, Vice President of Sales at The Copley Consulting Group. “Our FDA Extended Solution is the perfect fit for firms that need to consolidate their systems and automate their quality processes.”
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. https://copleycg.com
HemoSonics is a medical device company offering a novel point-of-care diagnostic platform to guide the management of critical bleeding to improve outcomes and reduce healthcare costs by enabling more targeted transfusion of blood products. The Quantra® System is designed to transform the way clinicians manage coagulation dysfunctions by providing comprehensive, timely information on coagulation status at the point of care. HemoSonics is headquartered in Charlottesville, VA, with research, development and manufacturing facilities in Durham, NC. For more information, visit www.hemosonics.com.