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Addressing the Unique and Specialized Needs of Medical Device Manufacturers

As medical device manufacturer, you are focused on running efficient discrete production activities, yet you must meet the same FDA compliance guidelines as pharmaceutical/life sciences companies that have formula-driven production processes. Your company's success depends on having a fully integrated solution for addressing the challenging demands of your industry, including compliance with regulatory agencies, strict quality assurance requirements, short product life cycles and multiple subcontractors.

Fine-tuned to meet your specific industry requirements, Sage ERP X3 provides the advanced functionality you need to remain competitive in the face of these difficult challenges.

Functionality Tailored to Your Needs

Sage ERP X3 combines advanced manufacturing, distribution, warehousing, customer relationship management (CRM), and accounting functionality with application features that address the unique and specialized needs of your company, such as:

  •  Full lot and serial number traceability
  •  Electronic signatures with transaction audit traceability
  •  Quality management
  •  Sophisticated pricing and contract management
  •  Sub-contracted operations and supply chain control
  •  Post-sale service and support
  •  Extensive device history
  •  Advanced order fulfillment and inventory allocation procedures
  •  Comply with Government Regulations

Accessing the information required for government reporting (like FDA regulations and validation and 21 CFR Part II) is a time consuming labor. Sage ERP X3 also helps your company comply by providing a convenient and efficient way to gather and monitor relevant process information and eliminating manual procedures throughout the manufacturing process.

 Protect your business

Your success depends on your ability to manufacture superior products. You must follow closely controlled processes to develop and manufacture products that meet the strictest quality standards. If a defect does occur, you need to take immediate action not only to prevent consumers from serious health problems or death, but also to protect the viability of your business.

In order to help minimize the risks of a product recall, Sage ERP X3 provides complete forward and backward lot traceability. A full audit trail and archive of historical transactions is maintained for multi-year periods. The fully integrated quality control process rigorously enforces inspections to assure item conformance to any required characteristics, operational tolerances or expected results.

Achieve operational excellence

Sage ERP X3 also offers differentiating functionality that fosters cost reductions and customer service improvements – features like multi-site planning, finite capacity scheduling, user-defined workflow, real-time business intelligence and integrated automated data collection. Plus, it can be deployed as a Web and/or desktop application in Windows, Unix or Linux.

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