Medical Device & Medical Supplies Traceability Solutions
Top 5 Essential Benefits for Medical Device and Medical Supply Operations
Medical Traceability and Compliance Software
Optimize FDA Compliance with Advanced Real-Time Tracking
KnarrTek’s BellHawk and MilramX platforms enable manufacturers and distributors of medical supplies and devices to achieve robust traceability while meeting stringent FDA regulations, including CFR 21 Part 11. These solutions eliminate manual paperwork, ensure compliance with Good Manufacturing Practices (GMP), and provide real-time visibility into inventory, production, and supply chain operations.
Utilizing barcode scanning, RFID, and wireless mobile devices, KnarrTek offers scalable, cost-effective tools that reduce labor, minimize errors, and enable precise, limited recalls to safeguard consumers and reduce costs.
BellHawk for Medical Supply and Device Traceability Solutions
BellHawk is a robust Manufacturing Execution System (MES) and Warehouse Management System (WMS) designed for pharmaceutical manufacturers and distributors. It replaces paper forms and manual data entry with barcode scanning and mobile devices, ensuring compliance with FDA’s CFR 21 Part 11, DSCSA, and GMP standards. BellHawk’s real-time tracking and traceability capabilities help organizations avoid costly recalls, protect brand reputation, and maintain consumer safety.
Materials Tracking
Monitor materials by lot and serial number, storage locations, expiration dates, quality control metrics, and hazardous material classifications.
Traceability Records
Capture data on ingredients used in products, enabling quick forward and backward traceability to pinpoint defect origins and reduce recall scope.
Quality Assurance
Document every production step, including quality assurance checks and test results, to comply with GMP and internal quality standards.
Label Automation
Generate GS1- or UCC/EAN-compliant barcode labels tailored to specific products and customers, ensuring accuracy and regulatory compliance.
Live Data Insights
Offer a real-time overview of inventory, production progress, equipment usage, labor, quality checks, and order fulfillment.
BellHawk Applications for Medical Traceability
BellHawk supports a wide range of operations for medical supplies and devices, offering a versatile solution for manufacturers, distributors, and laboratories seeking enhanced traceability and real-time visibility. From managing assets to coordinating multi-site operations or ensuring FDA compliance, BellHawk provides tools to track materials, monitor jobs, and integrate with existing ERP or accounting systems without costly replacements.
Manufacturing and packaging of medical devices and supplies, ensuring traceability and quality control.
RFID asset management for multi-site operations, with real-time product labeling and traceability.
Laboratory testing and reagent production, tracking specimens, chemicals, and equipment usage.
Multi-site operations, integrating tracking across geographically distributed plants and distribution centers.
Efficient Traceability Workflow
Streamlined Manufacturing, Distribution, and Laboratory Processes
BellHawk optimizes operations for medical supplies and devices with a traceability-focused workflow:
- Receive and track raw materials and components with barcode scanning to ensure accurate inventory and compliance.
- Monitor production processes (e.g., assembly, sterilization, packaging) in real-time for efficiency and quality.
- Maintain detailed traceability records for FDA compliance, accessible for regulatory audits.
- Automate quality control checks and label printing to ensure product safety and accuracy.
- Manage picking, packing, and shipping with real-time data integration for seamless distribution.
MilramX: Real-Time Decision Support for Traceability
MilramX is a real-time, rules-based decision support platform that enhances supply chain coordination and data exchange. Built on the Microsoft stack (Visual Studio, IIS, SQL Server), MilramX provides intelligent, automated solutions for materials management, integrating seamlessly with BellHawk and other systems like ERP, QuickBooks, or Oracle. It delivers actionable, real-time information to support traceability and decision-making, reducing delays and improving efficiency.
Smart Automation
Employs an intelligent-agent framework to manage parallel tasks like data transfers and notifications, optimizing supply chain processes.
Data Integration
Collects and processes data from multiple systems, converting it into High Level Data Objects (HLDOs) for streamlined operations.
Operations Dashboard
Monitors purchase orders, work orders, move orders, and shipments in real-time for enhanced oversight.
Error Management
Features automated error detection and correction for continuous operation, with alerts for IT support when needed.
Adaptable Integration
Connects with ERP, CRM, and other systems, supporting applications in pharmaceuticals and related industries like medical supply chains.
Benefits of KnarrTek Medical Traceability Software
The combination of BellHawk and MilramX delivers transformative results for medical supplies and devices operations:
- Rapid Traceability: Enables instant one-step-backward and one-step-forward tracking to comply with FDA regulations, minimizing recall scope.
- Cost Savings: Pays for itself in six months or less through labor savings, reduced errors, and minimized waste.
- Enhanced Safety: Tracks materials and personnel to mitigate risks, ensuring consumer safety and regulatory compliance.
- Operational Efficiency: Provides real-time visibility and automation, reducing manual processes and improving inventory and production management.
- Scalability: Tailored for small to mid-sized organizations and multi-site operations, with customizable solutions to fit unique business needs.
KnarrTek’s solutions address the challenges of modern medical supplies and medical devices operations, emphasizing traceability to meet FDA’s CFR 21 Part 11 and GMP standards. BellHawk eliminates manual paperwork while ensuring compliance, and MilramX enhances decision-making with real-time data integration. Together, they provide a cost-effective, scalable solution that improves efficiency, reduces recall costs, and ensures consumer trust.
Interested in learning more? Click the button below to access KnarrTek’s Whitepapers by Dr. Peter Green.
KnarrTek's Capabilities
Inventory & Asset Tracking
Learn how we help you accurately track inventory and assets across your facility
RFID Inventory System
See how RFID technology can streamline and automate your inventory tracking.
Real-Time WIP Tracking
Discover how KnarrTek enables real-time visibility into your work-in-process operations, across all sites.
Materials Flow & Job Tracking
Find out how our solutions monitor material flow and job progress throughout production.
Track & Trace Materials
Explore how KnarrTek’s software makes it easy to track and trace materials from receiving to shipping.
