Medical Devices
AX for Pharma 365™ drives precise operations supporting the sales, design, manufacture, distribution, and usable life of Medical Devices

AX for Pharma 365™ drives precise operations supporting the sales, design, manufacture, distribution, and usable life of Medical Devices

The medical device industry is advancing with extraordinary speed, delivering life-enhancing innovations built on the power of automation and wireless technology. And while time-to-market is critical, safety can never be compromised. Quality and reliability must be tightly woven into every step throughout product design, manufacturing, distribution and maintenance.

When quality is a strategic priority, there is no room for human error. Your organization needs a digital foundation designed to connect and control the data, processes, and reporting that guarantees unremitting quality.

AX for Pharma 365™ is the cloud-based ERP platform—specifically designed to meet the exacting needs of the medical device industry—that will connect and control your entire operations. Natively integrated with Microsoft Dynamics 365 business management platform, AX for Pharma 365™ drives efficient operations supporting the sales, design, manufacture, distribution, and usable life of medical devices.

AX for Pharma 365™ provides a clear picture of financial and operational performance in real time and streamlines compliance to meet the strict regulatory controls on medical devices. Our AX for Pharma 365™ implementation and support team brings deep expertise in Microsoft technologies as well as real-life experience with the product design, manufacturing, and distribution challenges you face every day.

Advanced Quality Control
    • Through AX for Pharma 365™’s end-to-end ERP solution, the AXP 365 Advanced Quality Management™ module, LIMS (Laboratory Information Management System) monitors quality control and sampling for critical raw materials and components, and manufactured products. The ECM (Engineering Change Management) module assesses impacts, revises workflows, and documents changes across the entire product lifecycle to reduce production disruptions.
  • Ensure the quality system functionality that fully supports compliance with the FDA’s 21 CFR standards.
  • Enforce GMP (Good Manufacturing Practices) meeting the quality system requirements to design, produce, and distribute medical devices that are safe and effective.
  • Protect data from end to end ensuring full confidence in tight data security that will meet rigorous compliance requirements.
Enterprise Resource Optimization
    • AX for Pharma 365™, natively integrated with Microsoft Dynamics 365 Finance & Operations, provides a real-time overview of everything from purchasing and sales to accounting, project management, manufacturing, quality control, supply chain, warehouse management, delivery, and customer service management.
  • Streamline manufacturing with Manufacturing Execution System (MES) to automate production processes from end to end and deliver accurate real-time visibility into your supply chain.
  • Effectively manage purchasing, production, sales, distribution and maintenance of complex Medical Devices through AXP 365 Project Operations.
  • EAM (Enterprise Asset Management) to support proactive maintenance.
  • PDM (Product Data Management) and PLM (Product Lifecycle Management) to trace medical devices history.
Unified Process and Data Management
    • Providing a platform for the flow of information across your business, AX for Pharma 365™ connects and unifies every aspect of your operations. The native integration with Microsoft Dynamics 365 Finance & Operations ensures seamless workflows that collect and secure data.
  • Simplify financial operations from across the organization to plan, manage, and complete medical devices projects on time efficiently and within budget.
  • Automate DMR (Device Master Record) tracking and documentation, and record DHR (Device History Record) details and history for each medical device lot and unit from manufacturing through distribution to patient use.
  • Monitor performance and key indicators to optimize operations.