ERP Solution for Medical Devices2021-10-06T09:47:45-04:00

ERP Solution for Medical Devices

The Medical Device Industry is continuously changing, and Copley can help you overcome the challenges associated with change. To keep your business growing, you need to keep up with the business processes and system requirements to develop new resources and improve performance in this increasingly driven industry. FDA compliance, traceability, and quality are vital factors of your business success. This demanding environment means your company must reduce costs, streamline operations, and revolutionize rapidly to remain competitive.

Within this complex industry there is tremendous opportunity.

It is imperative to have a modern ERP system that is FDA compliant and capable of meeting the requirements of this unique industry.

Adopting a modernized ERP solution for your medical device organization gives you the leverage needed to successfully manage product lifecycles, supply chains, compliance, and documentation requirements.

FDA Regulation requires special production techniques, materials, and packaging for medical products and forces organizations to keep rigorous control over engineering and operations. The ability to create detailed work orders and access real-time data is essential to keep production moving. Manufacturers require accurate, reliable information about operations, device history, and costs to bring products to market quickly while keeping within the FDA guidelines for validation and assurance, electronic signatures, lot and serial traceability, and Title 21 CFR compliance.

Copley can help you meet and work through business challenges such as:

  • Meeting FDA regulatory requirements
  • Obtaining compliance across US and Europe
  • Support for mixed mode manufacturing
  • Automate service and product reordering
  • Reducing regulatory risk
  • Connecting disparate systems and manage outside processes
  • Paperless Quality Management System and inventory processes

FDA Regulated Solution Features

The Copley FDA Extended solution has several key features to ensure compliance.

DMR/DHR

Full Lot & Serial Tracking

Approved Vendor Management

eSignature Controls

CoA & CoC Report for Manufactured Lots

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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Our FDA Regulated Clients

 
 

Our FDA Regulated Clients

 
 

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Case Study

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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Copley’s FDA Regulated Resources

Quanterix

BionX Medical Technologies

HART (Harvard Apparatus)

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