ERP Software for Healthcare / Medical Industry
From raw material to finished product, from production line to sterilization — manage your medical device and consumable manufacturing with end-to-end traceability. Guarantee patient safety and regulatory compliance with ISO 13485 compliant quality management, UDI-based tracking, and validated production processes.
Industry Challenges
Challenges You Face
ISO 13485 and Regulatory Compliance Requirements
Medical device manufacturing is subject to strict regulations including ISO 13485, CE/MDR (Medical Device Regulation), and FDA 21 CFR Part 820. Complete documentation, validation records, and audit trails are mandatory at every production step. Manual record-keeping increases non-compliance risk and turns audit preparations into weeks-long burdens.
UDI (Unique Device Identification) and Full Traceability
UDI regulations require every medical product to be tracked with a unique identification number. Serial/lot-based traceability from raw material to finished product, from sterilization to patient use, is critical for identifying affected products within minutes in recall scenarios.
Sterilization, Shelf Life and Special Storage Conditions
A significant portion of medical products require sterilization, while raw materials and finished products may need storage in temperature, humidity, and light-controlled environments. Failure to manage shelf life, FIFO/FEFO practices, and storage condition monitoring leads to product spoilage, increased waste, and regulatory sanctions.
Multi-Country Licensing and International Trade
Exporting medical devices to different markets involves varying licensing requirements, certification processes, and customs regulations per country. Managing parallel documentation for different authorities like CE, FDA, and ANVISA, along with multi-currency trade operations outside ERP, causes operational errors and market access delays.
Drug and Device Tracking System Compliance
Regulatory reporting of pharmaceutical and medical products to health authorities is a legal requirement. Unique QR code-based tracking of each product, real-time reporting of production-warehouse-sales-return movements, and correcting erroneous reports when managed manually leads to serious operational errors, penalties, and product launch delays.
Harmony ERP Solutions
Solutions for Your Industry
Validated Production and Process Control
Automatically generate production orders with MPS and MRP engines. Control validation-required processes such as cleanroom production, sterilization, and packaging on a work order basis. Meet validation requirements with operator competency checks, process parameter recording (temperature, pressure, duration), and electronic signatures at every production step. Collect real-time data from the production line via kiosk terminals.
Full Serial/Lot Traceability and UDI Management
Track every product from raw material to final package by serial and lot number. Automatically generate and label UDI codes during the production process. Query with a single click which raw material lot was used in which production order, which operator produced it on which line, and which customer it was shipped to. Report all affected products and customers within minutes in recall scenarios.
ISO 13485 Compliant Quality Management
Manage FMEA (Failure Mode and Effects Analysis), Risk Analysis, and CAPA (Corrective/Preventive Action) processes digitally. Verify raw material certificates, dimensional measurements, and biocompatibility test results with Incoming Quality Control. Collect real-time measurement data at critical production stages with in-process quality control. Guarantee measurement reliability with calibration tracking. Minimize audit preparation times by digitalizing inspection instructions and control plans.
Shelf Life and Storage Conditions Management
Prevent waste of shelf-life-sensitive raw materials and products with FIFO/FEFO (First Expired, First Out) management. Meet regulatory requirements with lot-based expiry date tracking, quarantine stock management, and storage condition (temperature, humidity) recording. Improve stock accuracy in multi-warehouse setups with barcode-based warehouse operations. Prevent critical material shortages with min-max stock levels and automatic purchase triggering.
Project-Based Cost Accounting
Calculate the actual cost of each product and production order by raw material, labor, sterilization, testing, and overhead. Perform variance analysis with standard cost comparison. Manage your pricing strategy data-driven with product family and customer-based profitability reports. Track licensing and certification costs on a project basis.
International Trade, Licensing and Regulatory Integration
Manage your foreign trade operations with integrated import/export cards, customs offices, multi-currency order and invoice management. Track country-based licensing statuses, certificate validity periods, and renewal schedules. Automate proforma invoice, packing list, and certificate of origin documentation. Automate health authority reporting with built-in regulatory tracking integration. Real-time QR code-based reporting, bulk notification support, and notification status tracking ensure seamless regulatory compliance.
Business Results
Benefits You Will Get
Guarantee ISO 13485 and CE/MDR compliance with validated production processes and electronic signatures
Identify affected products within minutes in recall scenarios with full serial/lot traceability and UDI management
Minimize audit preparation times and ensure quality assurance with FMEA, CAPA, and digital inspection instructions
Prevent product waste and meet regulatory requirements with FIFO/FEFO management and shelf life tracking
Manage product and customer-based profitability data-driven with project-based cost accounting
Eliminate penalty risk by automating health authority reporting with regulatory tracking integration
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