8 Information Management Challenges for UDI Compliance
“My team spends far too much time pulling together medical device data that’s scattered across different systems and reconciling it in spreadsheets to create compliance reports.” This quotation from a regulatory affairs leader at a medical device manufacturer highlights the impact of poorly managed medical device data on compliance reporting, such as the reports needed for the FDA’s Universal Device Identification (UDI) regulation. In fact, an overreliance on manual, time-consuming processes brings an increased risk of human error in UDI compliance reports.
If you are an information management leader working for a medical device manufacturer, and your compliance team needs quick and easy access to medical device data for UDI compliance reporting, I have five questions for you:
1) How many Class III and Class II devices do you have?
2) How many systems or reporting data stores contain data about these medical devices?
3) How much time do employees spend manually fixing data errors before the data can be used for reporting?
4) How do you plan to manage medical device data so the compliance team can quickly and easily produce accurate reports for UDI Compliance?
5) How do you plan to help the compliance team manage the multi-step submission process?
For some helpful advice from data management experts, watch this on-demand webinar “3 Enterprise Information Management (EIM) Best Practices for UDI Compliance.”
The deadline to submit the first UDI compliance report to the FDA for Class III devices is September 24, 2014. But, the medical device data needed to produce the report is typically scattered among different internal systems, such as Enterprise Resource Planning (ERP) e.g. SAP and JD Edwards, Product Lifecycle Management (PLM), Manufacturing Execution Systems (MES) and external 3rd party device identifiers.
The traditional approach for dealing with poorly managed data is the compliance team burns the midnight oil to bring together and then manually reconcile all the medical device data in a spreadsheet. And, they have to do this each and every time a compliance report is due. The good news is your compliance team doesn’t have to.
Many medical device manufacturers are are leveraging their existing data governance programs, supported by a combination of data integration, data quality and master data management (MDM) technology to eliminate the need for manual data reconciliation. They are centralizing their medical device data management, so they have a single source of trusted medical device data for UDI compliance reporting as well as other compliance and revenue generating initiatives.
During this this on-demand webinar, Kelle O’Neal, Managing Partner at First San Francisco Partners, covers the eight information management challenges for UDI compliance as well as best practices for medical device data management.
Bryan Balding, MDM Solution Specialist at Informatica, shows you how to apply these best practices with the Informatica UDI Compliance Solution.
You’ll learn how to automate the process of capturing, managing and sharing medical device data to make it quicker and easier to create the reports needed for UDI compliance on ongoing basis.
Also, we just published a joint whitepaper with First San Francisco Partners, Information Management FAQ for UDI: 20 Questions & Answers about Complying with the FDA Requirement for Unique Device Identification (UDI). Get answers to questions such as:
What is needed to support an EIM strategy for UDI compliance?
What role does data governance play in UDI compliance?
What are the components of a successful data governance program?
Why should I centralize my business-critical medical device data?
What does the architecture of a UDI compliance solution look like?
I invite you to download the UDI compliance FAQ now and share your feedback in the comments section below.