Medical Device Manufacturing Software System Requirements to Consider

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

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 Enterprise Management (Sage X3)?

Sage Enterprise Management provides medical device companies with the tools and functionality necessary to handle compliance and quality requirements while supporting internal communication and collaboration. Sage Enterprise Management 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 Southeast Computer Solutions today for more information on Sage Enterprise Management and how it can simplify your business processes and help manage your regulatory and compliance efforts.

About Southeast Computer Solutions

Southeast Computer Solutions is based in Miami, Florida, and has additional operations in Mexico. For over 30 years, we have positively impacted the success of small and mid-sized businesses with effective business management implementations that improve our clients’ operations. We listen, we are accessible, and we care. Learn more by visiting our website or calling 305-556-4697.