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Using PIM to Facilitate UDI Compliance

By Kelle O'Neal

On February 24, 2014

Following our webinar on UDI Compliance, I wrote an article on “Mastering Product Data To Facilitate UDI Compliance”, now featured in this month’s issue of Information Management. To summarize the article:

Fictitious UDI - Using PIM to Facilitate UDI Compliance
Fictitious example of what a unique device identifier (UDI) would look like on a medical device label. The label contains information about the product name, its expiration date, reference and lot numbers, manufacturer information, bar code, and details about the item.

The FDA’s ruling last year requires that medical devices distributed in the United States must carry a Unique Device Identifier or UDI, a result of the passage of The FDA Amendments Act of 2007.

Master data management for product data, also referred to as a product data hub or a product information management (PIM) solution, has since become a valuable component of an overall solution for medical device companies to address Unique Device Identifier (UDI) compliance — especially when teamed with similarly focused data governance and data quality management programs.

A PIM solution enables centralization of all product information from various systems, creating a single view of product data that can be leveraged across all lines of business and distribution channels. More than being just a repository for product data and UDI records however, a PIM solution helps to automate the business processes necessary to create, track and manage the coded numbers and labeling information required for compliance. By leveraging the workflow capabilities of PIM solutions, organizations can ensure proper approval processes are followed and an audit trail exists to demonstrate traceability and transparency to regulators. Employing a PIM solution also reduces the manual burden of data management and human intervention which then increases efficiency and productivity associated with UDI compliance.

Organizations that do not yet have a standard approach to mastering medical device data can otherwise begin to establish a product data hub to address UDI compliance, which will allow them  to subsequently extend those capabilities to master, optimize, and govern other organizational product data. This will, ultimately, enable these organizations to be better prepared for future regulatory requirements.

Read the full article in this month’s issue of Information Management here.

To replay our webinar on How Enterprise Data Management Enables UDI, click here.