The Copley Consulting Group

FDA regulated

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IMMY Case Study

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 Case Study

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 Challenges
  • 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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The Copley Consulting Group is Proud to Have Made the Inc. 5000 List

The Copley Consulting Group is proud to have made the Inc. 5000 list of the fastest-growing private companies in America for the third time!

With a 61% growth over the past three years, Copley’s key to growth is the expansion of the Qlik analytics business which is complemented by the Copley’s focus on Infor ERP solutions tailored to the FDA Regulated industry. With Copley’s FDA Extended ERP solution, we provide a validated software solution for medical device manufacturers and other highly regulated Life Science firms. Copley is the sole channel partner for Infor specialized in the FDA regulated industry and the top revenue partner for Qlik in the Public Sector market.

Copley has a commitment to building and maintaining the technical skills needed to provide our customers with the highest level of service across the Infor and Qlik ecosystems. Our software solutions help streamline the business processes for some of the most innovative and complex environments in the market, whether it is biotech, robotics, or some of the largest state agencies.

To learn more about Copley, please visit our website at copleycg.com.

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Copley Receives CRN Award for Technical Excellence

The Copley Consulting Group is proud to have been named a top CRN Tech Elite 250 company, having earned the highest number of advanced technical certifications from leading IT vendors. Copley Consulting has a commitment to building and maintaining the technical skills needed to provide our customers with the highest level of service across the Infor and Qlik ecosystems. We are honored to accept this award and will continue to improve our skill sets and vendor certifications to meet our clients’ demands.

By bringing this technical expertise to our customers, we provide them solutions that delivers advanced security, auditable data, electronic recording, and business intelligence capabilities to improve their business processes. Organizations today are looking for solution providers that fully understand the technology products they sell in order to ensure they derive the maximum business value from those solutions.

The Copley Consulting Group provides enhanced functionality, detailed documentation and targeted services for all its clients. As an example, for businesses in FDA regulated markets, we work hand in hand with clients to ensure their computer software solution is validated, as this is a critical component of maintaining regulatory compliance.

Copley Consulting is committed to maintaining the highest levels of certification and is excited to be part of this prestigious list of Tech Elite Companies as recognized by the premier reseller media company, CRN.

Please contact us if we can assist as you transform your business to meet compliance regulations.

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