--- title: 5 Things to Consider When Defining Your UDI Strategy description: If you're in the medical field, new regulations are coming, and you'll need new software. Consider these 5 things when defining your UDI strategy. image: https://blog.southeastcomputers.com/hs-fs/file-2211152169-jpg/Images/medical-devices.jpg --- **[Sage X3](https://www.southeastcomputers.com/sage-enterprise-management-infomation) | **[Sage 100cloud](https://www.southeastcomputers.com/sage-100cloud-information) | [Acumatica](https://www.southeastcomputers.com/acumatica-information) | [LATAM Fiscal Requirements](https://www.southeastcomputers.com/latam-fiscal-requirements-localize-sagex3-sage-500) | [Contact Us |](https://interact.southeastcomputers.com/contact-us) [ 888-773-2161](tel:888-773-2161)**** [![logo-naw-southeast-website](https://blog.southeastcomputers.com/hs-fs/hubfs/logo-naw-southeast-website.png?width=578&height=160&name=logo-naw-southeast-website.png "logo-naw-southeast-website")](https://www.southeastcomputers.com) This is a search field with an auto-suggest feature attached. - There are no suggestions because the search field is empty. ![Florida Miami Image](https://blog.southeastcomputers.com/hs-fs/hubfs/Banners/Florida-Miami.jpg?width=2880&name=Florida-Miami.jpg "Florida Miami Image") # Blog Want our new blog posts delivered right to your inbox?  March 8, 2016 # 5 Things to Consider When Defining Your UDI Strategy - [Tweet](https://twitter.com/share) ![authorIcon](http://www.sparkreaction.com/hubfs/Oceania%20Theme%202016/Images/authorIcon.png) By [Abe Farhan](https://blog.southeastcomputers.com/author/abe-farhan) ![topicIcon](http://www.sparkreaction.com/hubfs/Oceania%20Theme%202016/Images/topicIcon.png) [UDI](https://blog.southeastcomputers.com/topic/udi), [All](https://blog.southeastcomputers.com/topic/all) [![5 Things to Consider When Defining Your UDI Strategy](https://blog.southeastcomputers.com/hs-fs/file-2211152169-jpg/Images/medical-devices.jpg) ](https://blog.southeastcomputers.com/5-things-to-consider-when-defining-your-udi-strategy) The FDA has passed legislation requiring all medical devices to have a unique device identification (UDI) number to make them recognizable and traceable across the entire medical field. By 2020, all medical devices must have labels containing the UDI, which is readable by both humans and machines. The information about each device then has to be submitted to the FDA’s Global Unique Device Identification Database (GUDID).   **If you are in the medical field, therefore, you are going to need to make some adjustments to be compliant with these new regulations.**   ### Why UDI with Southeast Computer Solutions? Hear from Abraham Farhan.** ** ** ** ## Defining a UDI Strategy Before you can [outline a UDI strategy](https://blog.southeastcomputers.com/what-you-need-to-know-about-a-udi-implementation-strategy), though, you must understand your business's current product data structure and identify gaps in your current processes; you should also focus on the cleanliness, totality, and standardization of your product's master data. Only after you’ve accomplished these tasks can you map a new environment specific to the UDI requirements.   [The first step is choosing a system](https://blog.southeastcomputers.com/medical-device-erp-system-requirements-you-should-consider) to record your product's UDI data. The system serves as a hub for all product data and will share master UDI data with external systems, including the FDA GUDID and the GS1/GDSN data pools. ## What to Ask Yourself **Consider these questions as you analyze your current product data management system and consider your [UDI implementation strategy](https://blog.southeastcomputers.com/what-you-need-to-know-about-a-udi-implementation-strategy): **   - Are you planning to source data submissions to the GUDID from a single system or will you multi-source and aggregate the data from several existing systems? - Does your current system serve as your strategic “go-forward” solution for gathering, housing, and distributing product data? - Is your data set small enough to manage data cleansing/normalization manually or will you need an enterprise resource planning solution to produce quality output? - Is your planned solution built on open technology that can support data imports from and data exports to other systems? - Does your solution include tools and workflows to manage product approvals and integration processes? **The FDA offers 3 methods to update the GUDID, including: ** - Manual entry via the FDA web portal - Entry through the GS1 GDSN data pool - Bulk XML HL7 SPL web service submission Answering those questions and considering those methods will drive any strategic decisions you make regarding a data management system and your overall UDI implementation strategy, with the end goal being UDI compliance.   For more information about implementing a UDI system, [contact](https://www.southeastcomputers.com/contact-us.php) Southeast Computer Solutions today. 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[NEXT POST **](https://blog.southeastcomputers.com/improving-customer-service-via-the-cloud) ### Related posts [Read More](https://blog.southeastcomputers.com/erp-solutions-for-pharmaceutical-manufacturers) ### [5 Things to Consider When Defining Your UDI Strategy](https://blog.southeastcomputers.com/erp-solutions-for-pharmaceutical-manufacturers) By [**Abe Farhan**](https://blog.southeastcomputers.com/author/abe-farhan) August 3, 2016 There are several ERP systems on the market designed to address the specific challenges facing pharmaceutical manufacturers. When you're.. ![topicIcon](http://www.sparkreaction.com/hubfs/Oceania%20Theme%202016/Images/topicIcon.png) [UDI](https://blog.southeastcomputers.com/topic/udi) [Read More](https://blog.southeastcomputers.com/6-ways-sage-x3-can-help-your-udi-implementation) ### [5 Things to Consider When Defining Your UDI Strategy](https://blog.southeastcomputers.com/6-ways-sage-x3-can-help-your-udi-implementation) By [**Abe Farhan**](https://blog.southeastcomputers.com/author/abe-farhan) March 15, 2016 To remain FDA compliant, all medical devices must have labels that contain a [unique device identification (UDI)](https://interact.southeastcomputers.com/establishing-a-udi-system) – a number that makes.. ![topicIcon](http://www.sparkreaction.com/hubfs/Oceania%20Theme%202016/Images/topicIcon.png) [UDI](https://blog.southeastcomputers.com/topic/udi) ### Search  --- ### Recent Posts ### Posts by Topic - [All (267)](https://blog.southeastcomputers.com/topic/all) - [Sage Enterprise Management (94)](https://blog.southeastcomputers.com/topic/sage-enterprise-management) - [Sage X3 (85)](https://blog.southeastcomputers.com/topic/sage-x3) - [ERP (60)](https://blog.southeastcomputers.com/topic/erp) - [Productivity (31)](https://blog.southeastcomputers.com/topic/productivity) - [Inventory Control (30)](https://blog.southeastcomputers.com/topic/inventory-control) - [Acumatica (21)](https://blog.southeastcomputers.com/topic/acumatica) - [Food and Beverage (21)](https://blog.southeastcomputers.com/topic/food-and-beverage) - [Cloud Computing (14)](https://blog.southeastcomputers.com/topic/cloud-computing) - [Community (13)](https://blog.southeastcomputers.com/topic/community) - [Sage 100cloud (12)](https://blog.southeastcomputers.com/topic/sage-100cloud) - [Sage 100c (11)](https://blog.southeastcomputers.com/topic/sage-100c) - [Add-Ons (10)](https://blog.southeastcomputers.com/topic/add-ons) - [UDI (9)](https://blog.southeastcomputers.com/topic/udi) - [Manufacturing (8)](https://blog.southeastcomputers.com/topic/manufacturing) [![Sage100cloud_RGB](https://blog.southeastcomputers.com/hs-fs/hubfs/Sage100cloud_RGB.png?width=442&name=Sage100cloud_RGB.png "Sage100cloud_RGB")](https://blog.southeastcomputers.com/sage-100cloud-information) [![Sage500_logo](https://blog.southeastcomputers.com/hs-fs/hubfs/Sage500_logo.png?width=369&name=Sage500_logo.png "Sage500_logo")](https://blog.southeastcomputers.com/sage-500-information) [![sage x3 logo](https://blog.southeastcomputers.com/hs-fs/hubfs/sage%20x3%20logo.png?width=640&name=sage%20x3%20logo.png "sage x3 logo")](https://blog.southeastcomputers.com/sage-enterprise-management-infomation) [![Acumatica_Logo450](https://blog.southeastcomputers.com/hs-fs/hubfs/Acumatica_Logo450.png?width=450&name=Acumatica_Logo450.png "Acumatica_Logo450")](https://blog.southeastcomputers.com/acumatica-information) ### About Us Successful transformation of a company’s systems and business processes requires strong project leadership with a passion to create effective processes-processes that will work for today and assist in further growth. ![scs-logo-short.png](https://blog.southeastcomputers.com/hs-fs/hubfs/scs-logo-short.png?width=500&name=scs-logo-short.png "scs-logo-short.png") ### Useful Links #### Services - [Software Implementation](https://www.southeastcomputers.com/software-implementation) - [Project Management](https://www.southeastcomputers.com/project-management) - [Software Training](https://www.southeastcomputers.com/software-training) - [Software Support](https://www.southeastcomputers.com/software-support) - [Custom Programming](https://www.southeastcomputers.com/custom-programming) - [IT Consulting](https://www.southeastcomputers.com/it-consulting) - [International](https://www.southeastcomputers.com/international) --- #### Products - [Sage X3](https://www.southeastcomputers.com/sage-enterprise-management-infomation) - [Sage 100cloud](https://www.southeastcomputers.com/sage-100cloud-information) - [Acumatica](https://www.southeastcomputers.com/acumatica-information) - [Sage 500](https://www.southeastcomputers.com/sage-500-information) ## Recent Blogs ### Get in Touch #### Miami Location **15165 NW 77th Ave., Suite 2009 Miami, FL 33014 ** [888-773-2161](tel:888-773-2161) ** [Info@southeastcomputers.com](mailto:info@southeastcomputers.com) Within business hours, we'll reply in 24 hours or less --- #### Mexico Location ** Miraflores 221, Col. 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