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FDA Compliance

Brooks Software and AssurX Release Real-Time Electronic Device History Record Software

Published: Tuesday, January 25, 2005 - 22:00

Brooks Software and AssurX Inc. recently released the first real-time electronic device history record (eDHR) software for the medical device industry. The eDHR solution incorporates components of both companies’ software and allows medical device manufacturers to convert their paper-based device history records into easily accessible electronic files. It enables users to reduce costs, time-to-market and part substitutions, and perform online captures of compliance data and creation of manufacturing audit trails that meet FDA regulatory requirements.

“Our real-time eDHR solution gives medical device manufacturers a cost-effective way to meet the FDA’s requirements for quality, and product and process traceability,” says Joe Bellini, senior vice president of Brooks Software. “Combined with AssurX’s nonconformance and quality management capability, we now offer medical device manufacturers an electronic device history record solution with unmatched performance and functionality that can be easily integrated into their manufacturing environments.”

For more information, visit www.brooks.com or www.assurx.com.


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AssurX Inc. develops quality management and regulatory compliance software solutions to help companies in any industry exceed quality expectations, ensure compliance, manage risks, and better govern their enterprise. AssurX solutions securely handle manufacturing defects, complaints, change control, regulatory compliance, supplier quality, audits, risk, corrective and preventive actions, and more.