QCR's SMART System Receives FDA Certification At A Major Medical Device Company

Dallas, TX – February 15, 2007 – QCR's .Net Version of their SMART Quality Execution System has been FDA certified in a Major Medical Device manufacturing facility in Dallas, Texas.

The SMART system from QCR has received FDA certification at a major medical device company located in Dallas Texas. The software is 21 CFR Part 11 compliant and is being used to mistake proof processes in this maker of diagnostic equipment.  The final output of the software provides an electronic Device History Record (eDHR). As a regulated manufacturing facility, multiple requirements and detailed documentation are a part of our daily work lives. Many of these requirements rely on humans to perform all steps at or near perfection every day. In order to achieve expectations, the employees needed a tool to simplify many of their daily activities, specifically checking that " Training documentation is current " Tools and equipment are in current calibration " Manufacturing materials are within expiration date paramenters " Electrostatic Discharge (ESD) protection is verified " Appropriate NCRs are generated and closed " All manufacturing documentation is complete before releasing the product. SMARTprovides this tool by automatically verifying that these and other requirements have been met throughout the entire manufacturing process, thereby preventing mistakes and nonconformances from occurring.  

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