Enhanced FDA Compliance Capabilities Only with Copley

FDA Regulated2022-08-31T16:31:44-04:00

ERP Solution for FDA-Regulated Industries

FDA regulated industries need an ERP solution that helps them remain compliant. Copley Consulting Group has implemented Infor ERP with significantly reduced compliance risk for dozens of small- to mid-size medical device manufacturers across the United States. Our FDA Extended ERP Solution is an extension of Infor CloudSuite Industrial (Syteline) to support the required compliance mandates for all FDA regulated industries. These extensions address the key functional areas where transaction records are required to remain in compliance with the 21 CFR Part 11 regulation and support ISO 13485 and GAMP 5 guidelines.

Industries Served by Copley’s Extended ERP Solution

  • Medical Devices
  • Prosthetics
  • Compound Pharmaceutical
  • Organ Regeneration
  • Cosmetic Products
  • Food & Beverage
  • Ophthalmic Products
  • Environmental Safety Equipment
  • Stem Cell Solutions
  • Diagnostic Testing Solutions
  • Physical Rehabilitation Equipment

Solution Features That Ensure Compliance

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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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.

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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  • 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

  • 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.

  • 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

FDA Validation Tools

Copley’s FDA Extended ERP solution ensures validation of the software’s intended use while exposing a company to their risk of FDA audit non-compliance if not properly executed. Our experience with FDA requirements and manufacturing best practices for clients has led to our development of these templates and an implementation methodology to ensure FDA compliance.

Process Templates

If your Regulatory personnel have experience in leading an FDA Validation project that included the back-end ERP software, then you can leverage your internal resources by having them take the lead in the process. To support their efforts and to maximize their efficiency, the Copley FDA Validation Templates provide guidance to streamline their workload.

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OPQ Scripts

The extensive, detailed documentation required in support of your OPQ report can be burdensome to your organization, with errors requiring significant rework. The operational and performance validation scripts, developed specifically for the Infor Cloudsuite solution, help you reduce the effort, and lessens the risk of errors by facilitating compliance with these stringent requirements.

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Support & Services

Implementing an ERP solution for organizations that fall under FDA regulations must go through a validation process. The validation determines, defines, governs and documents the formal testing of Good Manufacturing Practices (GMP) and relevant activities pertaining to the definition, production and delivery of regulated products
and services.

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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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