Medical Device Manufacturing ERP Software System Requirements to Consider

By: | Category: ERP

The FDA, regulatory compliance requirements, challenging timetables, and strict quality assurance needs are only a few of the hurdles medical device companies face when searching for an enterprise resource planning (ERP) solution. Medical device companies frequently need to look beyond core functionality and focus more on scalability and flexibility — features that will help maintain a business model resilient enough to withstand an FDA inspection.

To fully manage quality and track product information, medical device manufacturers need to implement ERP systems capable of governing production, purchasing, documentation, and traceability.

What to Look for in an ERP Software for Medical Device Manufacturing

Below are some items to consider during the medical device manufacturing software system requirements and selection process. Does the software:

  • Provide a complete audit trail of manufacturing processes?
  • Include functionality to ensure that you can meet quality standards such as ISO 9001?
  • Meet FDA software validation requirements?
  • Have document control that complies with 21 CFR Part 1?
  • Include Integrated Corrective Action/Preventive Action (CAPA) functionality?
  • Provide lot and serial tracking and traceability capabilities?
  • Manage regulatory compliance requirements?
  • Have the capability to manage supplier/approved vendor data?

Above all, will it eliminate the time-consuming, paper-based tracking systems and processes you’re currently using?

Why Sage X3?

Sage X3 provides medical device companies with the tools and functionality necessary to handle compliance and quality requirements while supporting internal communication and collaboration. Sage X3 delivers industry-specific functionality with the flexibility to accommodate your current and future business requirements. Fully integrated quality control processes allow you to impose rigorous inspections and ensure your products conform to industry and operational standards.

Looking to implement a solution to manage the complexities of your medical device business? Contact the experts at Net At Work today for more information on Sage X3 and how it can simplify your business processes and help manage your regulatory and compliance efforts.