ERP Implementation Leadership for Regulated Manufacturing

When your ERP system struggles to support business growth, regulatory compliance, or the integration of acquisitions, you require experienced program leadership. Felaris excels in ERP strategy and implementation specifically for medical device manufacturing environments across the US, Caribbean, and Europe. We expertly manage vendor selection, facilitate organizational change, and oversee multi-site deployments, guiding projects from planning through to successful go-live.

The ERP strategy you choose significantly impacts your business for the next decade, especially in the context of medical device manufacturing and multi-site deployments. Felaris conducts requirements workshops with business stakeholders to gather insights, builds comprehensive vendor evaluation frameworks for effective vendor selection, develops total cost of ownership (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 for effective vendor selection

- Total cost of ownership (TCO) analysis

- Regulatory compliance assessment

- Technology roadmap alignment

- Executive decision support

Successful ERP strategy implementations in medical device manufacturing require strong business leadership, a clear project scope, and effective change management. Felaris offers comprehensive program governance from planning through post-go-live stabilization, covering aspects such as project planning, resource allocation, business process redesign, testing strategy, go-live planning, and cutover management. 

In regulated environments, ERP implementations also necessitate regulatory compliance through Computer System Validation (CSV). Explore our expertise in FDA/MDR Compliance & CSV services, including guidance on vendor selection and support for multi-site deployments.

ERP strategy in regulated environments necessitates robust features like audit trails, change control, regulatory reporting, and traceability. Felaris assesses ERP platforms for their alignment with FDA 21 CFR Part 11, ISO 13485, and EU MDR compliance, ensuring effective configuration of change control and audit trail capabilities, while validating data integrity. Furthermore, ERP implementations in medical device manufacturing and multi-site deployments require Computer System Validation (CSV) to meet stringent regulatory compliance requirements. Discover more about our FDA/MDR Compliance & CSV services to enhance your vendor selection process.

Implementing an efficient ERP strategy across multiple manufacturing sites, including operations in the Caribbean, introduces complexities in project management, change control, and maintaining operational consistency. Felaris excels in managing multi-site deployments by ensuring regional customization, enforcing global process standardization, and facilitating multi-currency and multi-language configurations. Additionally, we prioritize regulatory compliance and effective vendor selection, combined with robust 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) 

With a strong focus on ERP strategy, we possess platform-specific knowledge necessary for vendor selection, planning, and implementation in regulated environments like medical device manufacturing. Our experience encompasses compliance with FDA 21 CFR Part 11, ISO 13485, EU MDR, and Computer System Validation (CSV). 

Ensuring ERP data quality, master data management, and process documentation are vital for regulatory compliance and are essential disciplines for AI readiness. Organizations completing an ERP program with Felaris are equipped with a governed data foundation suitable for multi-site deployments. Explore our AI Business Foundation Services for further insights.

In the realm of medical device manufacturing, companies often focus on developing an effective ERP strategy to enhance their operational efficiency. This is particularly relevant for growth-stage companies engaged in regulated life sciences and pharmaceutical sectors. These firms face unique challenges, such as ensuring regulatory compliance and managing multi-site deployments effectively. Additionally, thorough vendor selection is crucial to support these complex processes.

Existing ERP strategies often fall short in supporting post-acquisition integration for multi-site deployments, particularly those operating on disparate or legacy systems. When facing ERP vendor selection for a new facility, product line, or entry into a regulated market, it’s crucial to address any regulatory compliance issues, especially those stemming from audit failures tied to ERP system gaps. Additionally, a digital transformation initiative necessitates experienced program leadership to guide these changes, particularly as legacy systems approach end-of-life and require a cohesive cloud migration strategy.