Featured Product
This Week in Quality Digest Live

More Videos

FDA Compliance Features
Protect Against Food Recalls With the Right Conveyor System
Del Williams
Mitigate risk, prevent safety issues by utilizing closed conveyor systems designed with sanitation in mind
EU Regulation Is Driving Medical Device Manufacturers from EU Market
Dirk Dusharme @ Quality Digest
Companies say they plan to pull some or all of their devices
Migrating Your QMS From Paper to AI
Dirk Dusharme @ Quality Digest
First step, migrate your QMS to a cloud-based electronic quality management system
Food Expiration Dates Don’t Have Much Science Behind Them
Jill Roberts
Another way to know what’s too old to eat
How Pharma Quality Leaders Navigate Shifts and Instigate Change
Patricia Santos-Serrao
Four pharma quality trends

More Features

FDA Compliance News
Husky Technologies Travels to Dubai
Showcasing tech, solutions, and services at Gulfood Manufacturing 2022
Maintaining Quality Assurance in Pharmaceutical Packaging
Easy, reliable leak testing with methylene blue
Supply Shortages Could Lead to Greater Food Fraud Risk
Now is not the time to skip critical factory audits and supply chain assessments
ETQ Releases Reliance NXG QMS and New Quality Events Application
Google Docs collaboration, more efficient management of quality deviations
Qualio Focuses on Building a New, Collaborative Life Sciences Ecosystem
Delivers time, cost, and efficiency savings while streamlining compliance activity
Exemplar Global and QLBS Partner to Launch Audit Simulator
First trial module of learning tool focuses on ISO 9001 and is available now
Greenlight Guru Launches Greenlight Guru Academy
Free education source for global medical device community
Study Finds Quality Shifting From Operational Compliance to Strategic Business Driver
Good quality is adding an average of 11 percent to organizations’ revenue growth
Greenlight Guru Updates Risk Management to Align With ISO 14971:2019
Further enhances change management capabilities

More News

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.

Discuss

About The Author

Quality Digest’s picture

Quality Digest

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.