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Quality, Efficiency, Traceability
Unify your business with Kinetic, a complete cloud ERP for medical device manufacturers.
Delivering on Your Trajectory for Growth
Helping you scale to match the growth of your business requires operational controls that optimize productivity and efficiency, while maintaining high standards for traceability and compliance. Epicor Kinetic offers a complete solution designed to meet your needs.
- Regulatory Compliance: Specialized cloud infrastructure for life sciences
- Operational Efficiency: Reduce time, complexity, and costs
- Integrated Data Management: Centralize data for actionable insights
Epicor Kinetic ranked a top ERP solution for manufacturers by G2
Capture the Benefits of Unhindered Scalability
Overcome the obstacles of point solutions with integrated medical device ERP software that handles your business’s growth and digital transformation needs—in a single platform.
- Increase visibility and monitor operations in real-time
- Reduce time, complexity, and costs
- Operate more accurately and efficiently
Meet Rigorous Regulatory Requirements
Reduce your noncompliance risks with validation services, product traceability, and quality control expertise including FDA CFR 21 Part 11 and EU Annex 11. Leverage the Epicor Life Sciences Cloud infrastructure to support software validation and continued compliance.
- Improve your validation readiness with expert guidance
- Stay current in the cloud—and ready for changing requirements
- Expand into new markets with global expertise
Accelerate Innovation and Business Momentum
Unlock possibilities for your rapid growth and improve business momentum with streamlined capabilities for the complex needs of medical device manufacturers. Kinetic ERP solutions are based on ‘always current’ methodology that supports your operations with the latest technology through regular updates on a deferred cadence that supports compliance requirements.
- Gain more resilience and security with Microsoft Azure cloud
- Improve quality control with integrated quality management
- Better compete with integrated planning capabilities
IZIEL
Software Validation Partner Spotlight
Epicor understands the challenges with compliance faced by manufacturers in Life Sciences and has teamed up with industry experts to streamline software validation for the initial go-live as well as establish a comprehensive software validation process for ongoing management. Coordinating with Epicor's proven software validation partner, IZiel Healthcare offers a thorough program to quickly and effectively meet regulatory requirements, while helping to establish a sustainable path to support compliance with annual software upgrades.
Challenges Solved for Medical Device Manufacturers
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
Resources
Success Stories
- Kinematic Automation Inc
- SHL Group
- Axelgaard Manufacturing
- The Baker Company
Kontakt
Tausende Hersteller verlassen sich bei Unternehmenswachstum und Skalierung auf Epicor. Wir beantworten Ihre Fragen gern. Lassen Sie uns wissen, was gut läuft und wo es Verbesserungsbedarf gibt. Wir stellen gemeinsam mit Ihnen die passende Lösung für Ihr Unternehmen zusammen.