Demo: Epicor Kinetic for Medical Device Manufacturers

Epicor ERP Solutions for the Medical Device Industry

In the medical device industry, compliance is continuous, not a one-time event. Manufacturers must maintain validated systems, closed-loop quality processes, and complete traceability across the product lifecycle. ERP plays a central role in ensuring data integrity, audit readiness, and operational consistency in an increasingly regulated environment.

A Unified ERP Platform Built for Compliance

In regulated environments, ERP is the operational backbone. Epicor Kinetic centralizes business data across departments, ensuring information is accurate, accessible, and auditable. Advanced security controls allow organizations to define access by role, group, field, or data set, while built-in audit trails capture who changed what, when, and why — supporting continuous audit readiness.

Epicor’s change logs, field-level security, and full transaction traceability ensure manufacturers can meet evolving regulatory requirements without slowing down operations.

Solutions Tailored to Industry-Specific Challenges

Medical Device Manufacturing

Medical device manufacturers often face strict software validation requirements that can limit ERP modernization. Epicor addresses this challenge with a robust cloud infrastructure, flexible upgrade paths, and partnerships that simplify compliance.

Through collaboration with IZiel Healthcare, Epicor helps manufacturers streamline ERP software validation, while Epicor QMS, powered by ETQ, delivers a cloud-native quality management system that supports closed-loop quality processes, document control, and regulatory compliance.

Core Challenges in Regulated Manufacturing

Manufacturers in regulated industries consistently face several critical challenges:

• Compliance management across regions, products, and evolving regulations
• Consistent quality control without excessive cost
• End-to-end traceability from raw materials to finished goods
• Document control for SOPs, training records, and certifications
• Change management that minimizes disruption while preserving compliance
• Environmental regulations related to emissions, waste, and sustainability
• Ecosystem coordination across suppliers, partners, and internal teams
• Continuous audit readiness for unplanned inspections

Epicor Kinetic is designed to address these challenges through integrated tools, automation, and real-time visibility.

Embedded Analytics and AI for Smarter Decisions

Grow Business Intelligence (BI)

Epicor Grow embeds analytics directly into the ERP experience, delivering role-based dashboards and KPIs tailored to quality, finance, supply chain, and operations. Users gain actionable insights into metrics such as scrap costs, non-conformances, RMAs, and production performance.

Grow also functions as a standalone BI platform, enabling manufacturers to combine Epicor data with external systems, legacy data, spreadsheets, and cloud applications. This unified analytics approach supports faster reporting, deeper analysis, and better decision-making across the organization.

Epicor Prism AI

Epicor Prism is embedded AI that transforms how users interact with ERP data. Prism acts as:

• A knowledge assistant, summarizing help content and guiding users through tasks
• A data assistant, retrieving and filtering ERP data using natural language
• A multimodal analyst, interpreting dashboards and images to provide insights and recommendations

By reducing manual effort and improving access to insights, Prism enhances productivity while lowering the risk of human error.

Traceability, Auditability, and Quality Control

Epicor Kinetic provides full cradle-to-grave traceability through lot and serial tracking. Manufacturers can track materials from receipt through production, shipment, and beyond — capturing expiration dates, heat numbers, serial histories, and compliance attributes along the way.

Built-in audit trails, change logs, and right-click access to underlying transactions ensure transparency and accountability across the entire lifecycle of a product.

Advanced Inventory Planning and Optimization

With Epicor Inventory Planning and Optimization (IP&O), manufacturers can balance service levels, inventory investment, and demand variability. IP&O enables real-time visibility into inventory performance, supports what if scenarios, and applies statistical forecasting to account for seasonality and changing demand patterns.

By optimizing planning parameters, manufacturers can reduce excess inventory, improve fill rates, and increase margins—without compromising compliance or customer service.

Financial Planning, Analysis, and Reporting (FP&A)

Epicor FP&A extends visibility from operations into finance, enabling detailed budgeting, forecasting, and financial reporting. Users can drill from high-level financial statements directly into underlying ERP transactions, ensuring accuracy, transparency, and faster insight.

Role-based workflows, comments, and approvals support collaborative budgeting while maintaining control and governance.

Enabling Better Outcomes for Regulated Manufacturers

Together, Epicor Kinetic, Grow, Prism AI, IP&O, QMS, and FP&A form a connected ecosystem that helps regulated manufacturers:

• Maintain compliance and audit readiness
• Improve traceability and quality
• Gain real-time operational and financial insights
• Increase efficiency and reduce costs
• Build resilient, compliant supply chains

With the right ERP foundation, medical device manufacturers can move beyond reactive compliance and toward proactive quality management. Epicor helps organizations streamline validation, strengthen traceability, and maintain continuous audit readiness — all while supporting scalability and innovation.

1. How does ERP software help medical device manufacturers meet FDA compliance requirements?
Epicor Kinetic helps medical device manufacturers meet FDA compliance requirements by maintaining data integrity, audit trails, and document control across the product lifecycle. These capabilities support regulatory expectations for traceability, validation, and quality management within a single ERP environment. 

2. Can Epicor ERP support ERP software validation for medical devices?
Yes. Epicor supports ERP software validation through controlled change management, documented system updates, and partnerships that simplify validation processes. This helps medical device manufacturers modernize ERP systems while maintaining validated states required by regulators. 

3. How does ERP improve traceability for medical device manufacturing?
Epicor ERP provides cradle to grave traceability by tracking lots, serial numbers, and production history from raw materials through finished devices. This enables medical device manufacturers to maintain complete device history records (DHRs) and respond quickly to audits or recalls. 

4. What role does ERP play in closed loop quality management?
ERP plays a central role in closed loop quality management by connecting non conformances, corrective actions, documentation, and production data. Epicor integrates ERP with quality management systems to help medical device manufacturers enforce consistent processes and continuous compliance.