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UDI & DATA REMEDIATION

UDI & DATA REMEDIATION. Kristopher Williams Director, Global Product Presentation & Quality Planning 06 November 2014. UDI & data remediation. UDI compliance has resulted in three major projects Development of a system to load and maintain UDI attributes to the GUDID

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UDI & DATA REMEDIATION

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  1. UDI & DATA REMEDIATION Kristopher Williams Director, Global Product Presentation & Quality Planning 06 November 2014

  2. UDI & data remediation • UDI compliance has resulted in three major projects • Development of a system to load and maintain UDI attributes to the GUDID • Label configuration to meet the UDI barcoding requirements • Data collection and remediation of the data attributes

  3. UDI & data remediation • GUDID Data Attributes • All data attributes can be edited by the company within the 7 day grace period once the record is published to the GUDID • A few data attributes may be edited by the company at any time after the data is loaded • Most data attributes (Core Attributes) can not be changed by the company after the 7 day grace period, and will require the issuance of a new UDI to update

  4. UDI & data remediation • One of the biggest issues we as an industry have faced in compliance with the UDI rule has been data remediation • UDI attributes that are not currently tracked within our existing systems • UDI attributes that we do currently track, but are not 100% confident in the data • UDI attributes that we currently track, but are in obscure systems that are inadequate going forward

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