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12 August 2016

Integrated UDI support with KUMAVISION industry software: Optimal illustration of FDA regulations

The unique identification of medical devices (UDI) is mandatory from September 2016 for MPG Class II products for export to the FDA area (including US). KUMAVISION's ERP software helps companies placing medical devices on the market in compliance with UDI guidelines. Finishers and distributors benefit from master data maintenance of FDA-relevant product information. At the same time, the industry software controls the printing of labels and prepares the message to the so-called GUDID database. In addition, the introduction of UDI opens up great potential for companies to optimize and process their logistics processes.

UDI (Unique Device Identification) is a worldwide system for uniform product labeling of medical devices that was developed in the USA. The marking must be machine-readable - for example as a barcode - and in plain text on the product and / or the packaging. UDI consists of three building blocks: product data (UDI), data carriers (UDI Carrier) and the global database GUDID (Global Unique Device Identification Database). Using the UDI code, products in the database can be uniquely researched.
"We consistently adopt an integrated approach to our ERP software, which means we interconnect all process steps throughout the company, so our customers can access the UDI-required information that is already in the system and other required data (static data such as product information) KUMAVISION, which means that there is no media break, "explains Jürgen Baier, Head of Healthcare Solutions at KUMAVISION. The industry software thus already provides the standard for FDA and MPG-compliant product labeling. Variable data such as batch and serial numbers as well as the expiration date can be automatically generated by the software and used in all process steps (production, logistics, QA).

 

Simple GUDID upload

The FDA's UDI directive requires companies to enter certain product characteristics in the publicly accessible GUDID database. KUMAVISION simplifies the GUDID upload: The system generates an XML file that can be uploaded to the portal without further conversion. In addition, KUMAVISION plans to offer the direct upload from the industry software as a service in the future, so that even a high number of articles can be reported easily.

Automatic label printing

Another component of the UDI system is product labeling. In doing so, certain information must be applied to the product or packaging. KUMAVISION also supports companies in label printing with integrated processes. The industry software prepares the necessary data for compliant product identification and transmits it via an interface to a label printing program that handles the layout of the labels and the control of various printers. GS1 and HIBC are supported. The printing or the transmission can be done directly from the processes, sometimes even automated. Especially practical: individual labels (design, size, material) can be managed for different products.

Optimized logistics chain

The barcodes required for UDI offer great potential for optimizing warehouse and logistics processes. Already in the goods receipt and goods issue can be with scanners z. For example, enter serial and batch numbers and the expiration date and transfer them directly to the ERP system. This saves companies time and reduces the error rate by eliminating the need to manually collect information. As UDI is soon to be implemented in the EU under the definition "system of the unique product number", the product labeling and optimization potential will adjust promptly.

Well prepared, well networked

With KUMAVISION, companies that market medical devices are perfectly prepared for the introduction of UDI. The integrated ERP system and the company's many years of experience in the regulated environment provide the basis for seamless, company-wide mapping of FDA regulations. In addition to processes, KUMAVISION also networks similarly established customers, thus creating a practice-relevant exchange with UDI - especially in light of the fact that the European Union will adopt a corresponding regulation.

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