Press Release Summary:
To aid in achieving 21 CFR Part 11, GmP compliance, Change Management Solution tracks changes and controls automation software, devices, and equipment used on factory floor. Solution provides electronic record keeping, electronic signature, complete audit trails, and record security. Equipped with user-configurable interface and disaster recovery capability, it has open architecture and can connect to installed base of disparate plant floor systems.
Original Press Release:
GE Fanuc Automation Announces Proven Change Management Solution
Software Manages Production Changes to Help Achieve 21 CFR Part 11, GmP Compliance
NEW YORK - March 16, 2004 - GE Fanuc Automation Americas, Inc., a unit of GE Infrastructure, has announced a new Change Management Solution - which helps life sciences companies track changes and control versions of automation software, devices and equipment used on the factory floor, providing a framework to achieve 21 CFR Part 11 and GmP compliance. GE Fanuc launched the proven Change Management Solution at INTERPHEX 2004, March 16-18, Jacob K. Javits Convention Center, New York.
"One of the most challenging issues for manufacturers in the life sciences is the FDA's requirements for electronic records as defined in regulation 21 CFR Part 11 and its impact on controllers and other production device programs," said Bob Honor, manager of life sciences for GE Fanuc Automation. "In addition to helping companies achieve compliance, this proven solution also can help users protect against plant downtime due to device failures and operator errors."
Based on CIMPLICITYÂ® Manager software, the new Change Management Solution provides electronic record keeping, electronic signature, complete audit trails, and record security. The solution is designed for 21 CFR Part 11 and cGMP regulations and, with an open architecture, can connect to an installed base of disparate plant floor systems.
Now available, the new Change Management Solution has been installed and proven at pharmaceutical companies that have been audited and validated by the FDA. "Based on existing pharmaceutical applications, GE Fanuc can provide a measurable, near-term ROI," Honor explained, "from increased plant uptime, improved engineering processes, reduced engineering and maintenance costs, and lower capital expenses."
With a user-configurable interface that reflects specific facilities and equipment, the integrated and scalable Change Management Solution organizes and automatically tracks every element of a plant's automation/software systems. It can greatly enhance plant production system usability, reliability, and accountability so that efficiency, responsiveness, and regulatory compliance are all assured. The GE Fanuc Change Management Solution includes:
Â· Multi-Tier Security - Control and monitor access to systems at all levels. Offering a second layer of security above the operating system security is necessary for Part-11 compliance. This solution ensures that system changes are introduced only by authorized people, and automatically records the identity of those making changes.
Â· Electronic Signature - Traceability of changes is a primary requirement for FDA-regulated companies. In addition to tracing changes, assuring changes are authorized is important. The Change Management Solution allows configuration of electronic signatures at key points in the change operation. Before users can create a new version, they must be authorized to make those changes. Furthermore, an authorized reviewer must authorize changes to make them a reality.
Â· Automated Audit Trails - Track changes to applications and documentation. Another part-11 requirement, all system changes are managed and tracked automatically to ensure full maintenance of electronic records and to help prevent costly errors. With automatic checking in and out of files, only one authorized person can make changes at a time. Detailed reporting capabilities allow companies to view historical data in whatever format they require, and users can validate automatically that only approved versions of applications are running on devices.
Â· Disaster Recovery - The solution's Disaster Recovery capability lets companies restore their Critical Manufacturing PCs quickly. With single boot disk recovery, fast access to correct released versions, and data backed up automatically at a single source, companies can recover in as quickly as 15 minutes from a failure, not a full day.
Â· HTML interface and plant layout. The graphical plant layout lets a user customize the interface to match individual plant needs: point-and-click ease of use makes accessing projects and devices simple and provides a framework for remote troubleshooting. It also allows companies to give users access to only what they need, thus reducing errors and training.
About GE Infrastructure
GE Infrastructure is a high-technology platform comprised of some of the fastest-growing businesses within GE (NYSE: GE). With 2004 revenues expected to approach $3.5 billion, they represent a set of advanced protection and productivity solutions to some of the most pressing issues that industries face - pure water, safe facilities, plant automation and detecting changes in the operating environment. GE Infrastructure is headquartered in Wilton, CT.
About GE Fanuc Automation
GE Fanuc Automation, a joint venture between GE and FANUC LTD of Japan, delivers automation hardware and software designed to help users reduce costs, increase efficiency and enhance profitability. With solutions and services catering to virtually every industrial segment, GE Fanuc Automation provides a diverse array of capabilities and products, including controllers, embedded systems, advanced software, motion control, CNCs, operator interfaces, industrial computers, and lasers. Headquartered in Charlottesville, VA, GE Fanuc Automation is a part of GE Infrastructure and combines the diverse global strengths of the GE family with the local presence customers need to design, develop and maintain their automation investments.
For more information, visit www.gefanuc.com or contact: GE Fanuc Information Center, P.O. Box 8106, Charlottesville, VA 22906, Phone: (800) GE FANUC, Fax: 434-978-5205, e-mail: firstname.lastname@example.org.
CIMPLICITY is a registered trademark of GE Fanuc Automation Americas, Inc. All other trademarks are the property of their respective owners.