The Copley Consulting Group

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Triangle Manufacturing Company Accelerates Growth with The Copley Consulting Group and Infor ERP

Implementation of the Copley FDA Extended ERP solution has provided higher visibility into demand forecasting and quality control for medical device manufacturer.

Triangle Manufacturing Company, a premier contract manufacturer to OEMs of medical instrumentation and implantable devices, is realizing significant benefits since implementing The Copley Consulting Group’s FDA Extended Solution based on the Infor CloudSuite™ Industrial (CSI) Enterprise Resource Planning (ERP) application. The new ERP solution replaced Triangle’s disparate systems and manual processes, providing the functionality needed for them to improve production cycle times and shop floor efficiency to support their aggressive growth goals.

“With our prior, legacy systems, we lacked a unified platform that melded Quality Control, FDA Regulatory Compliance, and Shop Floor Control,” said Dax Strohmeyer, President at Triangle Manufacturing Company. “With Copley and Infor, we have successfully implemented a solution that provides real-time production feedback, allowing us higher visibility into margin contributions while enhancing our planning and scheduling. We feel the efficiencies we have gained with the Infor and Copley FDA solution will accelerate our growth trajectory, while maintaining our core values of quality and delivery performance.”

Triangle now sees the opportunity to more effectively on-board new customers at a faster rate, fueling their objectives of both top line and bottom line increases in this competitive and highly nuanced medical device sector.

“Triangle is a great example of an FDA regulated client who turned to Copley to track multiple processes across different areas of production in order to meet their growth goals and remain compliant with FDA regulations,” said Robert Lane, CEO at The Copley Consulting Group. “Our FDA Extended Solution is the perfect fit for medical device firms that need to consolidate their various legacy systems and automate their processes, yielding a compliant solution that grows with the company.”

About The Copley Consulting Group
The Copley Consulting Group helps organizations drive business transformation. With 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.

About Triangle Manufacturing
Partnering with our global OEM clients, Triangle Manufacturing Company Inc. brings to life a wide range of medical instrumentation and implantable devices at a time when reliable sourcing is more important than ever. Triangle’s work impacts almost every part of the human body, demanding a level of precision and quality unlike any industry. Triangle was founded in 1955 and is headquartered in Saddle River, NJ. For more information, visit https://www.trianglemfg.com.

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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

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Pine Pharmaceuticals Implements Copley’s FDA Extended ERP Solution

About Pine Pharmaceuticals

Pine Pharmaceuticals provides pharmaceutical compounding, including specialized sterile formulations serving ophthalmologists, retinal specialists, hospitals, medical practices and clinics. Their sterile compounded preparations are made to order and formulated using cutting-edge technology and industry-leading quality assurance practices.

Business ChallengesPine pharmaceuticals
  • Disparate systems which did not connect to each other
  • Manual quality system and inventory processes
  • Lack of integrated solution to mitigate FDA compliance risk
  • Need for system to meet current Good Manufacturing Practices (cGMP)
Benefits
  • They have implemented the Copley FDA Extended ERP Solution based on Infor CSI to automate all processes and accelerate the growth of their organization
  • Pine will be moving away from their manual quality system and inventory processes to an automated system
  • Pine will also be looking to put a more formal purchasing and planning system in place that they were missing prior to choosing Copley
  • The ERP system will help to increase efficiency and accelerate business processes while putting in place a solution that helps them meet strict FDA requirements
Quote

“We had a number of different systems in place that required very manual processes to get the information required.” With the continued growth of our company we needed to have a solution in place that could improve our processes to support this growth, while also helping us meet FDA requirements. With Copley we have the support we need to get the solution up and running to automate all of our processes and accelerate the recent success we’ve had here at Pine.”
– Alfonse J. Muto, President of Pine Pharmaceuticals

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HemoSonics Executes Copley’s FDA Extended Solution

About HemoSonics

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.

Business ChallengesHemoSonics | The Copley Consulting Group
  • Move away from manual processes to integrated and automated solution
  • Meet FDA regulatory requirements
  • Reduce regulatory risk
  • Compliance across US and Europe
  • Support for Mixed load manufacturing
  • Automate service and product re-ordering
Benefits
  • Copley Consulting implemented the FDA Extended ERP Solution system, which replaced manual systems and processes, providing all the functionality needed for HemoSonics to support their aggressive growth goals
  • Implemented an ERP system that could keep up with company growth and compliance mandates, while reducing regulatory risk
  • Handled all elements of the manufacturing process, including discrete manufacturing for the actual instrument and process-based for the cartridges
  • The FDA Extended Solution also allows the organization 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
Quote:

“With Copley, HemoSonics now has 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 their products through the manufacturing lifecycle, and to meet FDA software validation requirements, thus ensuring quality control.”
– Steve Erwine, CFO at HemoSonics

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