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AGA Medical Corporation wanted to increase and accelerate access to design, manufacturing, compliance, and other information to accelerate time to market for the company's products that require regulatory approval and replace unsustainable, paper-based processes that were put in place when the company was one-tenth of its current size. The challenge was to provide easy access to data to meet International Organization for Standardization, U.S. Food and Drug Administration, and Corrective Action/Preventive Action audit and compliance requirements. AGA Medical Corporation implemented Oracle's Agile product lifecycle management applications to unify device master information - including design drawings, bills of material, and manufacturing procedures - previously stored in different locations - into one master data source.

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Format:PDF
Date:Feb 2009

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