Quality, Efficiency, Traceability

Medical devices must comply with stringent regulations like those from the FDA and EMA. ERP systems help ensure compliance, track changes, and support audits and recalls. Regulatory demands on software validation often hinder tech updates, but Epicor provides cloud solutions with regular upgrades on a deferred cadence to maintain compliance without foregoing necessary updates.

• Life Science Cloud infrastructure for software validation
• Consistent upgrade cadence to always stay current
• Expert guidance with our software validation partner
• Enterprise level Epicor QMS for closed loop quality process, complaints handling and more
• Comprehensive end-to-end Product Lifecycle Management (PLM) from concept development and regulatory approval to market release and post-market surveillance

It's crucial for medical device manufacturers to trace each product back to its source materials. A capable ERP system allows for end-to-end traceability, from raw materials to the finished product delivered to the end customer.

Sophisticated Enterprise Content Management for document control and process automation

• Lot & Serial Tracked Parts, WIP PCIDs
• Serial Genealogy of components and products
• Reference Designator and manufacturers’ part cross-reference requirements
• Allocate parts for customers based on lot and serial designations

Regulatory requirements around software validation can make it difficult for manufacturers to access current technology and maintain up-to-date systems. Epicor offers flexible cloud solutions with upgrade cadences, supporting compliance with software validation without having to sacrifice regular updates.

• Azure Cloud Infrastructure for security, performance and reliability
• Embedded customer centric CRM functionality for proactive customer engagement and visibility
• Global multi-company/multi-site capabilities
• Flexible deployment options include cloud, on-premises and hybrid

Medical device manufacturers often need to interface with other systems, like CRM (Customer Relationship Management) tools or specialized quality management systems. Epicor’s robust API, Data Fabric & integrations solutions deliver seamless integrations between systems.

• End-to-end integrated framework establishing a digital thread to help optimize visibility and productivity from design to delivery, service and finance
• Accelerate your path to digital transformation with comprehensive product lifecycle & document management
• Collaborate together on product design and product issues through documents on a secure cloud location
• Drive product innovation and manage cost with complete visibility

Ensuring that devices meet consistent quality standards is paramount. ERPs can integrate quality checks, monitor quality metrics, and trigger actions if anomalies are detected. Complaints handling by advanced quality management adds another level of service and accountability.

• Adaptable QMS Solutions to mitigate quality and compliance risks
• Advanced Quality Analytics
• Best practice quality workflows to standardize quality processes and documentation
• Complaints Handling for Life
• Sciences Supplier Corrective Action, Planned Deviations, eMDR, and more