Medical device manufacturers face challenges that are unique in the manufacturing industry. They’re focused on running efficient, discrete production activities, but they must meet the same FDA compliance guidelines as pharmaceutical and life sciences companies with formula-driven production processes. Complying with strict and evolving regulatory requirements, as well as the necessity for comprehensive lot and unit tracking and the ability to maintain a nimble supply chain to reduce overhead, are a few of the challenges expressed by our medical device manufacturing clients.
How can you solve these challenges while remaining productive and profitable in a competitive marketplace?
A Prescription for Success
Sage ERP X3 is fine-tuned to meet the specific demands of the medical device industry, offering advanced functionality that enables companies to remain agile, responsive and competitive. Here are a few of the ways Sage ERP X3 can help:
- Full lot and serial number traceability
- Electronic signatures with transaction audit traceability
- Quality management
- Extensive device history
- Post sale service and support
- Extensive device history
- Advanced order fulfillment and inventory allocation functions
Comply with Government Regulations
Maintaining compliance with FDA regulations, Title 21 CFR Part 11 and changing health care legislation places an administrative burden on medical device manufacturers. An enterprise resource planning (ERP) solution designed with the medical device industry in mind, like Sage ERP X3, helps companies comply by efficiently and conveniently gathering and monitoring relevant process information and reducing the need for manual and redundant processes.
To mitigate the risk of a recall event and to speed response time when faced with such a situation, Sage ERP X3 provides full forward and backward lot and serial number traceability. The software maintains a full audit trail and archive of transactions for multiple years. In addition, a configurable quality control process ensures products conform to required characteristics, operational tolerances and expected results.
Lean & Efficient Manufacturing
At its core, Sage ERP X3 is a robust manufacturing solution, delivering features like multisite planning, finite capacity scheduling, configurable workflow, real-time business intelligence and integrated automated data collection.
Want to learn more about how Sage ERP X3 can solve the challenges medical device manufacturers face? You can read about one company’s success with Sage ERP X3 here. As always, BKD’s consulting team is ready to help.
Ricardo de Rojas
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