Are you seeking a comprehensive solution to ensure compliance with global regulations while simplifying your processes? Look no further, our premium solution KOA designed to streamline your regulatory compliance efforts, offering an array of essential features:

  • Diverses Regulatory Data Formats: KOA covers various regulatory data formats crucial for compliance across different regions.
  • Secure Data Publication: Benefit from a qualified interface ensuring the secure publication of your data.
  • Workflow Validation: Control data quality, integrity, and timeliness through a validated workflow.

Tailored for the healthcare product industry, KOA is meticulously crafted to meet all your requirements efficiently. Allow us to assist you in constructing your Product Master Data.

Empowering Your Data Integrity, KOA the pathway to compliance 

User-Friendly Interface

KOA’s ergonomic design simplifies data entry. Guided by attribute labels, drop-down lists, and intuitive buttons, creating product sheets becomes quick and straightforward. Our adaptable form content adjusts according to integrity rules, easing the process for users without specialized data modeling expertise.

Effortless UDI Implementation

With KOA, product coding aligns seamlessly with industry standards such as GS1, IFA, HIBCC, and ICCBBA. These coding standards are seamlessly integrated into our software, ensuring compliance without complexity.

Data Integrity Assurance

Integrating global regulatory data models into KOA facilitates comprehensive Product Master Data generation. You can supplement these models with organization-specific data, enabling seamless catalog sharing with commercial partners (GDSN) and distributors.

Quality Assurance and Compliance

Control the integrity of your data with KOA. Our solution intertwines Master Data administration with quality processes. Users undergo identification on the platform, and data updates follow a meticulous validation workflow.

Certified Master Data

Ensure your business information system receives verified data. Comply effortlessly with regulations such as EUDAMED, GUDID, SWISSDAMED, and more. Seamlessly share product data with diverse partners via GDSN.

Security and Performance

Rest assured with KOA hosted on the Microsoft Azure platform. Certified interfaces facilitate direct data publication to multiple databases, ensuring synchronization without manual intervention. Monitor the publication status of all your products effortlessly.

Diverse Data Model Integration

Expand your business by linking to regulatory databases worldwide, including EUDAMED, GUDID, SWISSDAMED, AUSTRALIA, SAUDI ARABIA, and beyond.

Comprehensive Traceability Management

KOA generates essential traceability data (batch numbers, dates, serial numbers) within one platform. Track your product throughout its lifecycle, from identification and production to storage and delivery.

Empower your compliance journey with KOA – the ultimate solution for mastering regulatory compliance while simplifying data management.

Please contact us to learn more about all KOA’s features and how it can be adapted to your core business.

Performance

  • Registration and storage of Basic UDI & UDI-DI data
  • Synchronising data to Eudamed and tracking
  • Tracking and traceability from the production line to the distribution centre
  • Tracking and traceability by product batch and/or serial number
  • Analysis of production data

Was this content helpful?