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Microsoft Dynamics 365 ERP for Medical Device Manufacturing

Why Us

an-erp-for-life-sciences-ctaTackle government regulations, achieve faster innovation and take control of your supply chain with Microsoft Dynamics 365 for Finance and Operations (formerly Dynamics AX).

Dynamics 365 offers a scalable solution to help medical device manufacturers accommodate rapid growth—be it through organic or M&A activity—leverage existing infrastructure and manage complex supply chains, as well as vendor, distributor and client relationships.

As a Dynamics 365 partner to top medical device manufacturers, Armanino brings industry best practices to help you address operational and financial hurdles, consolidate business processes and institute a system to help you reduce costs and quickly adapt to changing market needs.

Product Traceability in a Regulated Environment

Armanino’s Dynamics 365 medical device ERP and CRM solution includes enhanced inventory control to track inventory by lot number or serial number.

  • Items that are tracked by serial number cannot be received, sold or moved without specifying serial numbers for each item
  • Ensures inventory policies regarding serial numbers are enforced from cradle to grave
  • Integrated warranty management and field service
  • Device history record
  • Revision and item attribute control, from engineering through manufacturing to service management
  • Material master record (MMR) and electronic batch record (EBR) support
Managing Product Defects
  • Return material authorizations (RMA)
  • Replacement parts
  • Warranty management and tracking
  • Field service and install base support
  • Corrective and preventative action (CAPA) / defect analysis tools
  • Advanced quality management
  • Identifying non-conformance
  • Product recall
Supply Chain Management

Gain control of your supply chain with:

  • Improved customer/vendor visibility and collaboration through data sharing and integration options
  • Support for intercompany transactions
  • Increased visibility into WIP tracking
  • Eliminate data redundancy
  • Tools for multichannel management
  • Robust demand forecasting capabilities
  • Reduced inventory cost through improved planning
Regulation & FDA Validation Compliant
  • Food and Drug Administration (FDA) computer system validation
  • 21 CFR Part 11 electronic records and signature
  • Current Good Manufacturing Processes (cGMPs) 3, 4, and 5
  • Health Insurance Portability and Accountability Act (HIPAA)
  • Sarbanes-Oxley Act (US 2002)
  • Data Protection Directive (EU 1989)
  • Hazard Analysis and Critical Control Point (HACCP)
  • Payment Card Industry Data Security Standards (PCI DSS)
  • ISO 9001:2008 & ISO 13485:2003 quality management systems
  • Sunshine Act
Product Lifecycle Management
  • Rapid new product introductions
  • Export compliance
  • Engineering change control revision control management
  • Managing end-of-life
  • License key management for software
  • Expiration and shelf life dates
Robust Tools & Integration Capabilities
  • Streamline data handoff between in-house and vendor systems
  • Reduce redundancy
  • Automate operations
  • Eliminate/consolidate costly systems

Resources

Infographic: Solve these Top 12 Life Sciences Challenges with Dynamics AX

See how we deliver the robust ERP capabilities of Microsoft AX, plus extended functionality to help life sciences companies overcome critical regulatory, quality and business challenges.

Life Sciences Industries for Microsoft Dynamics AX

Quality, reporting, compliance and complex financials – we’ve got you covered. Get the most comprehensive Microsoft Dynamics ERP solution available for Life Sciences manufacturers within the Medical Device ...

Microsoft Dynamics Support Services

When your organization faces technical problems, our team of Microsoft Dynamics Certified consultants is here to help.

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As manufacturers add connectivity to their products, they are generating data that can provide new revenue streams and business models.

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As the FDA rolls out its UDI system, medical device makers must generate large volumes of data to meet their heavy compliance requirements.

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Medical Device Industry Suite

Armanino has deep expertise on relevant enterprise resource planning modules and system integrations for the Medical Device industry. We are one of the largest Microsoft Dynamics ERP in the nation.

Return Material Authorization (RMA) Solution

Armanino’s managed solution for Microsoft CRM provides a comprehensive Return Material Authorization (RMA) process that supports manufacturers and distributors in RMA tracking, process automation, ...

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Integrating Best Practice Revenue Management Intelligence into Your ERP

In recent years, the FASB has provided a number of updates to the GAAP around the revenue recognition rules for companies that sell multi-element arrangements, where some of those elements have their own delivery sche ...

Armanino’s Revenue Management for Dynamics AX Solution

Companies that sell bundled products including hardware, software, services, prepaid support tickets, warranties and maintenance agreements need to be able to break out these multi-element orders to comply with US GAA ...

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This white paper provides a detailed framework to help you and your organization plan and execute a successful new ERP solution selection process – step-by-step.

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Supply Chain Integration

Supply Chain Integration for Dynamics AX increases supply chain visibility by integrating with your subcontractors, vendors and trading partners. Traditional trading partner integration is difficult and ...