Medtech Manufacturer Software helps drive GMP-compliance.
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Press Release Summary:
Utilizing SOA methodology, Brooks MEDIC(TM) solution suite provides complete regulatory process management and compliance system for medical device manufacturers. Risk management and mitigation system lets users control all critical data across operational and business systems. Real-time applications, services, and solutions allow manufacturers to link each pillar of operational and business systems into House of Compliance(TM) for complete regulatory process management across enterprise.
Original Press Release:
Brooks Software Releases MEDIC(TM) Solution Suite for Medtech Manufacturers
Suite of Applications to Drive GMP-Compliance into Manufacturing to Improve Quality and Lower the Cost of Compliance
CHELMSFORD, Mass., Jan. 31 / -- At MDM West today, Brooks Software, a division of Brooks Automation, Inc. (NASDAQ:BRKS), and a leading provider of real-time applications for discrete manufacturing environments, announced a comprehensive suite of solutions that offer a complete regulatory process management and compliance system for medical device manufacturers. The Brooks MEDIC solution suite provides a risk management and mitigation system allowing device manufacturers to control all critical data across operational and business systems. The Brooks MEDIC solution suite goes beyond electronic device history record systems (eDHR) to help manufacturers make better informed decisions to improve manufacturing quality and lower the cost of compliance.
"The critical challenges facing medical device manufacturers today are lowering the cost of regulatory compliance, improving quality, and automating operations to drive GMP-compliance into manufacturing," said Joe Bellini, president and chief operating officer for Brooks Software. "The Brooks MEDIC suite provides a complete solution addressing design, manufacturing, quality, traceability and regulatory requirements. Based on a manufacturing compliance framework, the MEDIC suite provides companies with the capability to mitigate risk and comply with the growing number of mandated regulations."
The Brooks MEDIC suite provides real-time applications, services and solutions allowing medical device manufacturers to link each "pillar" of their operational and business systems into a House of Compliance(TM) for complete regulatory process management across the enterprise. The MEDIC suite allows device manufacturers to drive GMP-compliance into their manufacturing operations by integrating specific solution-based pillars as their business needs grow over time. The MEDIC suite consists of eight key pillars:
o Manufacturing Compliance Framework -- utilizes a service-oriented architecture methodology that represents the "plumbing" required to create composite applications and seamlessly connect the various MEDIC pillars and other legacy applications and address compliance across global manufacturing operations.
o Design to Manufacturing -- helps companies design better product and manufacturing processes, validate designs, and transition the design to volume production by ensuring that production quality planning and process optimization can be integrated into the design process.
o Manufacturing Execution Systems -- enables medical device manufactures to manage key production processes, capture full product genealogy, and gain full visibility to all key areas of the production process.
o Enterprise Quality Management -- provides a closed loop, end-to-end solution that helps companies control documents, manage complaints and product recalls, exceptions, CAPAs, Root Cause Analysis process, audits, suppliers, and training records.
o Equipment Asset Management -- manages and automates many key equipment centric functions such as preventative management, tool status, spare management, and work instructions/orders.
o Manufacturing Process Optimization -- integrates deep statistical methodologies with process execution, which can be used to drive unprecedented manufacturing performance.
o RFID -- includes all of the hardware and software necessary to fully track and trace product through the production process and beyond.
o Reporting and Portals -- provides manufacturers with a leading edge reporting, alerting, and analysis engine that is integrated with the entire Brooks MEDIC suite.
Medical device organizations are tasked with growing their businesses in a continuously evolving regulatory environment. Brooks is working with leading solution providers, such as Microsoft, to address business goals and compliance requirements. "The House of Compliance concept helps device manufacturers to build composite applications based on regulatory goals as well as a company's bottom line," said Joseph Vinhais, vice president of regulatory affairs for Brooks Software. "We are excited about the value and innovation that the Microsoft platform brings to our life sciences solution. Together we will enable our life sciences customers to innovate and reduce costs while meeting compliance goals."
"The combination of Brooks Software's expertise in complex manufacturing environments and the depth of their life sciences team will benefit our mutual customers," said Pradeep Rathinam, general manager, US ISV, Microsoft Corporation. "We are delighted to see their commitment to the Microsoft platform we will continue to work in close partnership with them to achieve their vision of improving the productivity and compliance of medical device manufacturers."
The Brooks MEDIC solution suite is based on a manufacturing compliance framework that utilizes a service oriented architecture (SOA) methodology and leverages composite applications. The resulting risk avoidance framework provides the "intelligence" and analytics required to make faster, more accurate decisions to derive greater strategic value from a manufacturer's investment.
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 about Brooks Software's MEDIC suite of solutions visit http://lifesciences.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/.
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Contact:
Jeff Nestel-Patt
Director of Marketing
Brooks Software
(978) 262-4497
jeff.nestel-patt@brooks.com
