To remain FDA compliant, all medical devices must have labels that contain a unique device identification (UDI) – a number that makes them recognizable and traceable across the entire medical field – by 2020. The UDI, readable by both humans and machines, offers the opportunity for global transparency in the medical field.
Businesses in the medical field, of course, will have to take steps to ensure their compliance with this evolving FDA standard.
In our previous blog, 5 Things to Consider When Defining Your UDI Implementation Strategy, we discussed several ways to start planning a UDI strategy unique to your business. In short, it said that you can’t outline a UDI strategy without first understanding your business’s current product data structure and identifying gaps in processes.
When delving into creating and implementing a UDI strategy with a more architectural approach, most businesses quickly realize several key issues during their initial analysis phase, including:
- Difficulties managing product data stored in multiple systems and/or locations (ERP, CRM, PLM, spreadsheets, etc.).
- Large product volumes requiring the need for electronic and/or semi-automated solutions (as product data cannot be managed or updated manually).
- The need to establish and implement more formalized product data processes and solutions across the organization.
Using an ERP
But there’s an enterprise resource planning (ERP) system that can help – Sage Enterprise Management (Sage X3). Southeast Computer Solutions helps their clients implement Sage Enterprise Management, allowing their clients to meet industry and organizational requirements by creating user roles and preferences to deliver simple, easy-to-use software on any web browser or mobile device. The UDI project management team at Southeast Computer Solutions have years of development and implementation experience and will deliver a solution tailored to your needs.
Why UDI with Southeast Computer Solutions? Hear from Abraham Farhan.
The Sage Enterprise Management platform also provides the following features to help facilitate industry compliance and standardizations while creating a UDI implementation:
- Powerful data quality management to cleanse and standardize product data imported from multiple sources.
- An open architecture to manage cross-platform processes from various data sources and destinations, such as the FDA’s Global Unique Device Identification Database (GUDID).
- Standards and regulatory compliance tools and functionality (21 CFR Part II Compliance, GS1 product identifiers [GTIN], HIBCC [SLS] product identifiers, and GS1 product data pools [GDSN]).
- Configurable product data approval workflows.
- Extensive data models that capture all requisite Device Identifiers (DI) and Product Identifiers (PI) attributes required by the FDA.
- Highly configurable, rules-based governance processes.
The medical device industry is one of the most competitive and highly regulated industries in the world, making it critical to have a data management system. Let the experts at Southeast Computer Solutions help you optimize your processes, maintain regulatory compliance, and sustain your competitive advantage.