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: