Brooks Software Delivers First Real-Time Electronic Device History Record Solution for Medical Device Manufacturers
Brooks Software, a division of Brooks Automation, Inc. and a leading provider of real-time applications for enterprises with collaborative, complex manufacturing operations, today announced the first real-time electronic Device History Record (eDHR) solution for the Medical Device industry.
The Real-Time eDHR(TM) solution incorporates components of Brooks Software’s industry-leading FACTORYworks3(R) Manufacturing Execution System (MES) and AssurX Inc.’s CATSWeb(R) Non-Conformance and Corrective/Preventive Action (NC/CAPA) system. The eDHR solution allows medical device manufacturers to easily convert their paper-based device history records into an electronic, paperless solution that is based on the industry-proven performance and functionality of Brooks’ MES and AssurX’s NC/CAPA products. The Real-Time eDHR software enables medical device manufacturers to quicklyand easily achieve:
- Cost-effective paperless manufacturing operations
- Shorter time to new product introductions and part substitutions
- Online capture 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 andprocess traceability,” said Joe Bellini, senior vice president of Brooks Software. “FACTORYworks3 is a proven MES that provides increased visibility and control over the manufacturing process. By combining FACTORYworks3 with AssurX’s non-conformance 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.”
The real-time eDHR solution provides serialized component-level tracking and traceability and ives complete visibility to the As-Built Configurations (ABC) as well as the current status of all WIP on the shop floor. Using an intuitive user interface and XML standards-based integration, he eDHR configuration tools shorten implementation time and allow for easy adoption hroughout the enterprise, resulting in significant cost savings for the manufacturer — all of this with a solution that fully meets the FDA’s requirements of 21 CFR Part 820 and Part 11.
The real-time eDHR solution provides a growth path for medical device manufacturers to expand beyond regulatory compliance and provide greater control over plant-floor operations as their needs change over time. Using Brooks’ FACTORYworks3 for MES, AssurX’s CATSWeb and other Brooks Sense Decide Respond(TM) real-time enterprise applications, medical device manufacturers can easily add additional functionality allowing them to “sense” critical activity at the equipment, factory and enterprise levels; “decide” how to optimize production resources throughout the value chain; and “respond” by implementing informed, revised directives based on changing business conditions — all in real-time.
“The discrete FDA-regulated manufacturing industry is looking for a low risk solution to meet the FDA’s requirements for providing a complete electronic device history record,” said Tamar June, vice president, Strategic Marketing of AssurX, Inc. “Up until now, the industry has been served by small boutique companies with limited resources. Brooks brings the resources and depth of experience of a world-class software company with proven experience in running mission-critical manufacturing operations. AssurX is recognized as the leader in non-conformance, corrective action and quality management systems in the medical device industry. Together we deliver a world-class integrated solution that addresses the needs of the entire manufacturing enterprise.”
About AssurX, Inc.
AssurX, Inc. provides FDA-regulated manufacturers with enterprise-wide solutions for their quality system and compliance needs. CATSWeb is the proven leader as the industry’s enterprise quality software of choice used at FDA-regulated and ISO/QS 9000 certified companies around the world. CATSWeb is a zero client application that can be accessed from any computer, running any operating system, with any Web browser, anywhere and anytime that an Internet or intranet connection is available. CATSWeb is used at FDA-regulated companies around the world including Guidant Corp, Alcon Labs, Fischer Imaging, 3M Pharmaceuticals, and Bausch & Lomb. AssurX is headquartered in Morgan Hill, CA, with satellite offices throughout North America. For more information, please visit http://www.assurx.com or call 408-778-1376.
About Brooks Software
Brooks Software, a division of Brooks Automation, provides real-time applications that support enterprise-wide initiatives for greater efficiency and productivity in collaborative, complex manufacturing. Brooks’ Sense Decide Respond(TM) manufacturing software solutions are the foundation for enterprise initiatives in supply chain execution, closed loop automation, lean manufacturing and enterprise performance management. Installed in the majority of Fortune 500 manufacturers, Brooks Software delivers competitive advantage to aerospace & defense, automotive, high tech, life sciences and semiconductor manufacturers worldwide. For more information, visit http://www.brookssoftware.com
About Brooks Automation, Inc.
Brooks Automation delivers automation solutions to the global semiconductor and related industries. The company provides hardware, software, and professional services to help manage every wafer, reticle, and data movement in the fab, improving throughput and yield while reducing cost and time to market. Brooks’ products and capabilities are used in virtually every semiconductor fab in the world. For information, visit the company’s web site at http://www.brooks.com
