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Quality Digest

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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For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.