Global Unique Identification Database (GUDID)
Regulations issued by the Food and Drug Administration (FDA) in 2013 established the UDI (Unique Device Identification) rule, based on the different types of medical devices. In essence, this system set rules in place for structured product labeling and data submission to the Global Unique Identification Database (GUDID). Depending on the classification of the medical device (class III, as well as implantable, life sustaining, and life supporting), the codes required differ. Yet, the labels must be in plain text with automatic identification and capture technology. In short, the GUDID serves as a reference catalog for every device with a UDI. Characteristics about each device are included and referenced by the item code given by the labeler.
HAL Systems, Inc., is fully compliant with the format and requirements for UDI (unique device identification) as ruled by the FDA. The application of the HAL Traxx Software awards small to mid-sized businesses the complex capabilities to define and control items by code, as well as trace item production and history.
Privately owned, HAL Systems, Inc. works in your world, creating sophisticated software solutions that are cost-effective, allowing for seamless tracking and end-to-end product traceability.
HAL Traxx Software
The advanced technology of HAL Traxx Solutions equips businesses for supreme inventory management capability, minus the hefty cost. To meet requirements as specified by the Food and Drug Administration (FDA) in relation to the UDI (Unique Device Identification) rule, HAL Traxx Software generates a .zpl code for printing and barcode labels and RDIF (Radio Frequency Identification) tags with readable text to label medical devices based on classification. Each device is identified by a DI (Device Identifier) and established with an item code. To track production, production identifiers (PI) are assigned a master unit number along with a lot/batch number, date code, serial number, and identification code. The master unit number and RDIF tags are used to track items. Shipping is also tracked by way of the UDI. User, date, and time create a permanent record of every transaction. Finally, information required is submitted to GUDID as an .xml file and communicated through interface systems.
Do you need to ensure compliance for your small to mid-sized business? You don’t have to be a big company with a big budget to receive advanced technology for your company’s unique needs. The HAL Traxx Software at HAL Systems, Inc. makes it easy and affordable to manage inventory-receiving, movement, manufacturing and shipping, while ensuring quality control and compliance. Contact us today for more information about how we can help.