ERP for Medical Device Manufacturers2022-08-31T15:51:40-04:00

ERP for Medical Device Manufacturers

Reduce Compliance Risk and Scale Operations with Infor ERP

Copley Consulting Group has successfully implemented Infor ERP on behalf of dozens of small- to mid-size medical device manufacturers across the United States. Infor CloudSuite Industrial (Syteline) is a proven single system that helps medical device manufacturers maintain strict quality management and detailed product information, while fulfilling stringent regulatory requirements.

Outcomes Manufacturers Can Expect

One Enterprise Wide System

Eliminating or connecting disparate systems means better control, process automation and scalability

Double-Digit % Cost Reduction

Better control and automation equals time savings and safeguards that significantly reduce costs

Elimination of Compliance Risk

Meet FDA requirements and ISO 13485 certification, and obtain compliance across the U.S. and Europe

100% Paperless Operations

Enjoy efficiencies and save trees thanks to an electronic device record, bar-coded inventory, and much more

Enhanced FDA Compliance Capabilities – Only with Copley

Copley Consulting Group is the only Infor Gold Channel Partner to offer these additional regulatory compliance solutions for medical device manufacturers.

DMR/DHR

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DMR/DHR

Every record on building and testing a medical device is kept in a device master record. Any material proving your device is compliant is included in the device history file. Keeping your files well organized in an industry-specific medical device ERP system is essential.

Full Lot & Serial Traceability

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Full Lot & Serial Traceability

Every component of a medical device is lot traced. The trace functionality starts from the very beginning upon receipt of the material and is tracked to the specific work order that utilizes the traced material and the finished good.

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Quality Control

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Quality Control

Medical device manufacturers need an integrated quality system that is designed to fulfill ISO-certified operations. To stay within FDA guidelines, Infor SyteLine follows a specific focus in processing inspections, non-conformance, and corrective actions.

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Approved Vendor Management

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Approved Vendor Management

Infor SyteLine keeps records of your entire lifecycle from the idea stage to when it is available for users. When it comes time for an audit you will be expected to show how you manage your suppliers and ensure that the parts you are supplied with are compliant with regulations and meet your specifications.

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eSignature Controls

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eSignature Controls

The faster you can deliver your products, the better. eSignature Controls help you launch products sooner by increasing the efficiency of your approval and agreement processes, all while supporting your global compliance needs.

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CoA & CoC Report for Manufactured Lots

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CoA & CoC Report for Manufactured Lots

CoA & CoC reports document the quality assurance and confirms a regulated product meets the product specification. These contain the actual results obtained from testing performed as part of quality control of an individual batch of a product.

  • DMR/DHR

    Every record on building and testing a medical device is kept in a device master record. Any material proving your device is compliant is included in the device history file. Keeping your files well organized in an industry-specific medical device ERP system is essential.

  • FULL LOT & SERIAL TRACEABILITY

    Every component of a medical device is lot traced. The trace functionality starts from the very beginning upon receipt of the material and is tracked to the specific work order that utilizes the traced material and the finished good.

    Learn More

  • QUALITY CONTROL

    Medical device manufacturers need an integrated quality system that is designed to fulfill ISO-certified operations. To stay within FDA guidelines, Infor SyteLine follows a specific focus in processing inspections, non-conformance, and corrective actions.

    Learn More

  • APPROVED VENDOR MANAGEMENT

    Infor SyteLine keeps records of your entire lifecycle from the idea stage to when it is available for users. When it comes time for an audit you will be expected to show how you manage your suppliers and ensure that the parts you are supplied with are compliant with regulations and meet your specifications.

    Learn More

  • ESIGNATURE CONTROLS

    The faster you can deliver your products, the better. eSignature Controls help you launch products sooner by increasing the efficiency of your approval and agreement processes, all while supporting your global compliance needs.

    Learn More

  • COA & COC REPORT FOR MANUFACTURED LOTS

    CoA & CoC reports document the quality assurance and confirms a regulated product meets the product specification. These contain the actual results obtained from testing performed as part of quality control of an individual batch of a product

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Right-Sized Implementation

Copley offers four implementation service approaches━each with advantages and disadvantages. The right approach is dependent on your organization’s goals and needs.

This implementation approach is led by your internal project team with Copley experts providing guidance through a series of module-based workshops. Workshops cover core business processes in finance and operations supplemented by focused assistance with installation and enablement; execution of standard customer/vendor facing reports; data planning and execution.

Pros: This approach offers select clients the opportunity of low cost, self-implementation, while providing important guidance on enablement and core module business functions

Cons: Success is highly dependent on internal resources who have direct experience implementing enterprise level software solutions.

This implementation model offers a rapid deployment (in 3 to 4 months) with Copley experts executing nearly all of the work. This approach is ideal for start-ups or small organizations who have basic requirements and intend to leverage Infor’s core applications to get up and running and evolve into broader capabilities as business conditions demand.

Pros: This approach is cost efficient with minimal impact on your employees. Your organization’s involvement is limited to an intensive, multi-day session for solution design, data compilation, and user training based on Copley authored and delivered ISO level work instructions.

Cons: User adoption is best achieved through practice, repetition, and involvement in all phases of implementation, which this approach compromises.

This implementation approach involves deployment of Infor SyteLine or Infor CloudSuite™ (in 5 to 7 months) with shared program management and executive governance and oversight.

This approach is ideal for small to mid-size organizations requiring a thorough, but cost effective implementation that addresses a wide range of solution features and the business process variables encountered in most businesses. FDA validation using Copley’s exclusive FDA compliance solution is common in this model for regulated industries.

Cost savings are achieved by focusing business process design and core team training through a series of progressive Business Process Workshops and End-to-End Solution Testing sessions (Pilots). Your organization’s core team members representing the various functional areas assume responsibility for training the extended user community.

Pros: This thorough approach addresses business variables and unique organizational requirements, while achieving cost efficiencies. It also produces a more immersive user experience that achieves a higher degree of organizational adoption and ownership.

Cons: Requires a greater degree of involvement from your key staff over several months.

This final implementation approach involves deployment of Infor SyteLine or Infor CloudSuite™ (in 12 to 15 months) with the highest degree of Copley project management, governance, and oversight. This approach is ideal for large organizations (multi-site) with high regulatory requirements and is differentiated from Standard Implementation by the following characteristics:

  • An intensive degree of business process and technical expertise and project management.
  • Multiple pilots and data conversion tests
  • Greater emphasis on extended user training led by Copley experts
  • A larger scope of programmed data conversions
  • FDA Validation when applicable

Pros: The burden of implementation, including custom process configurations, regulatory compliance, and employee training, is placed squarely on Copley’s Infor experts━a process we have mastered over 30 years. This approach optimizes the impact on your human resources and offers peace of mind for a successful rollout across your entire organizational footprint.

Cons: Requires a higher implementation service fee (which can vary) and implementation can take up to a year or more.

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Case Studies

HemoSonics Implements Copley’s FDA Extended Solution

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.

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Triangle Accelerates Growth With Copley’s FDA Extended ERP Solution

Triangle Manufacturing Company Inc. was founded in 1955 and continues to bring 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.

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Copley’s FDA Regulated Resources

Quanterix

BionX Medical Technologies

HART (Harvard Apparatus)

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