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InterTech Development Co.

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FDA Compliance

Product News: New InterTech Development Component Tracker System

Published: Monday, April 19, 2010 - 15:03

(InterTech: Skokie, IL) -- Quality engineers seeking cost-effective ways to collect and archive test data for product life-cycle management systems and quality assurance, can now use the InterTech Development Component Tracker System, which integrates bar codes, scans, and software tracking of each part and batch, including all leak test, functional test, and life-cycle test data related to each component.

The InterTech Development Component System not only provides full traceability in the event of product recalls, but also provides data for process optimization to streamline production and storage of all test data at each production stage for statistical process control and ISO 9001 compliance.

For added traceability, a laser marking system can be integrated with the bar code label system.

“InterTech’s turnkey test solutions have always emphasized software integration to monitor all stages of testing and archival of all test data,” says Jacques Hoffmann, president of InterTech Development Co. “A growing number of InterTech customers in the medical device industry have been seeking ways to comply with a unique device identifier (UDI) system being called for by FDA regulators to facilitate product recalls. The InterTech Component Tracking System makes this same functionality to manufacturers of all types, such that the data archives for product life-cycle management systems and quality assurance are readily available.”

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About The Author

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InterTech Development Co.

InterTech Development Co. is a world leader in test-centric assembly and test specializing in automated leak and functional testing with seven patented mass flow and hydraulic technologies, as well as, helium mass spectrometry (ISO-17025 International Standards for Quality Management). InterTech Development Company-engineered solutions are used by hundreds of manufacturers worldwide. InterTech Development Company’s worldwide support organization maintains offices in North America, Asia, and Europe.