ERP Strategy, Advisory, and Program Leadership

When your ERP system cannot support business growth, regulatory requirements, or acquisition integration, you need experienced program leadership. Felaris leads ERP strategy and implementation for regulated manufacturing environments across the US, Caribbean, and Europe, managing vendor selection, organizational change, and multi-site deployments from planning through go-live.

The ERP decision impacts your business for the next decade. Felaris conducts requirements workshops with business stakeholders, builds vendor evaluation frameworks, develops TCO analysis, assesses implementation complexity and regulatory compliance, and supports vendor negotiation and contract optimization.

What you get: 

• Requirements workshops with business stakeholders
• Vendor evaluation frameworks and scoring
• Total cost of ownership (TCO) analysis
• Regulatory compliance assessment
• Technology roadmap alignment
• Executive decision support

Successful ERP implementations require business leadership, clear project scope, and effective change management. Felaris provides program governance from planning through post-go-live stabilization: project planning, resource allocation, business process redesign, testing strategy, go-live planning, and cutover management.

ERP implementations in regulated environments also require Computer System Validation (CSV). Learn about our FDA/MDR Compliance & CSV services. 

ERP systems in regulated environments require audit trails, change control, regulatory reporting, and traceability. Felaris evaluates ERP platforms for FDA 21 CFR Part 11, ISO 13485, and EU MDR compliance, configures change control and audit trail capabilities, and validates data integrity.

ERP implementations in regulated environments also require Computer System Validation (CSV). Learn about our FDA/MDR Compliance & CSV services. 

Deploying ERP across multiple manufacturing sites (including Caribbean operations) creates complexity in project management, change control, and operational consistency. Felaris manages multi-site rollouts with regional customization, global process standardization, multi-currency and multi-language configuration, and organizational change management.

• Primary Expertise: Microsoft Dynamics 365 Business Central 
• Additional Platforms: SAP (including GAMP 5 validation for regulated manufacturers), Oracle, Workday, NetSuite, Oracle Cloud 
• Integration Experience: eQMS, MES (manufacturing execution systems), PLM (product lifecycle management), WMS (warehouse management systems) 

Platform-specific knowledge for selection, planning, and implementation in regulated environments: FDA 21 CFR Part 11, ISO 13485, EU MDR, Computer System Validation (CSV).

ERP data quality, master data management, and process documentation are the same disciplines AI readiness requires. Organizations that complete an ERP program with Felaris already have a governed data foundation in place. See AI Business Foundation Services.

Medical device manufacturing, regulated life sciences, pharmaceutical, industrial manufacturing, growth-stage companies

• Existing ERP cannot support post-acquisition integration
• Multi-site operations running on disparate or legacy systems
• ERP selection for a new facility, product line, or regulated market
• Regulatory audit failures or findings tied to ERP system gaps
• Digital transformation initiative requiring experienced program leadership
• Legacy system end-of-life requiring cloud migration strategy