What does UDI mean for Agile PLM and Configuration Management?

I would like to thank Stephen Porter for this opportunity to share with you some of my thought regarding the recent FDA's ruling on Universal Device Identification (UDI) and where companies may fall short in their plans. There are several packaging and labeling requirements in this ruling and any organizations plans must include these new requirements. A small portion of this ruling, but a large impact long term is the managing of product data and its communication to the FDA. The FDA plans on making this data available for public and hospital information systems. Organizations already control information related to its product is a misconception. Not all the information is in clear and consolidated formats. As I sat through a planning secession over a year ago in a previous organization, the conversation was about how we would get the product information and who needed to be the owners or providers of this information. The problem was that we didn't know at that time, what information is needed. The question needed to be "what is the process for managing the information?" Not everyone can send or update data to the FDA's Global Unique Device Identification Database (GUDID). The solution was to identify a data steward. Consolidating the data to a single source and process is practical and helps limit the amount of errors. Is this a new department or new function that is added to a department? No. This is an extension of a process that already established in GMP organizations. It's called Document Control or Configuration Management. People in these roles have a particular ability to analyze a change and information impacted from the change. They take data from multiple functions and translate it into usable information in other systems. In its basic form, configuration management data is transformed from specifications, drawings and Bills of Materials into Enterprise Resource Planning (ERP) and manufacturing systems. In any Product Lifecycle Management (PLM) process this group must manage and interact with the data owners to update the GUDID for their organization. The cost of this process will be determined by how easy and quickly this group can manage the information. So, how does this system affect people that are using Oracle Agile PLM? Managing the UDI adds a layer of interchangeability to configuration management review of changes and new product development. Agile PLM is perfect place to manage the data that is part of the UDI. The UDI is a number or a part object that can easily be controlled as a part subclass along with the attributes that are required for the GUDID. If the FDA changes its mind on the data that is required Agile can easily add a field to accommodate that change. Permissions and data characteristics can be set for each type of required data. Bulk exports and updates can be made to the GUDID with a simple export on a regular basis. Using a part object, the configuration structure allows the UDI object to be the parent of a model number or manufacturing configuration. The GUDID is also now part of the Device Master Record (DMR). Even though for class III medical devices will require the UDI marked on the device, the parent/child structure sill makes the UDI as the highest level of information, not subordinate to the manufactured structure. Configuration Management must also think long term with this data. It is the FDA's intention to use the UDI in hospital systems and customer related information. Complaints and other issue management systems, i.e. lot numbers must be able to trace back to the specific UDI number. This will be difficult if the manufactured or inventory number doesn't maintain traceability and have interchangeability to the UDI. I guarantee that organizations will want to make revision changes to product and not change the UDI. As foreign of a concept that might seem, GS1/UPC and other UDI compliant structures allow for these types of changes. The key will be to develop interchangeability rules that are clean but allow flexibility and not over burden the organization. [clear] [clear]Now that the FDA's final rule organizations can execute a plan. Here is a summary of my recommendations regarding Configuration Management that a plan must include (not ranked or in a particular order).

• Add additional product labeling requirements to the labels
• Identify the data and process for updating the GUDID
• Identify information owners and data stewards
• Identify Interchangeability rules specifically with UDI

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About Tim Brown

Tim Brown, MBA is a Quality PLM Change Agent practicing with over 15 years in Configuration Management practices. His focuses have been in the areas of Quality, Configuration Management, class III medical devices, electronics, organizational development, management strategy, and training development. He is an ASQ certified Manager of Quality and Operational Excellence. His work in configuration management and master product data has created systems and structures that reduce risk to the patient and improved development lifecycle.[clear][clear-line]