FOR IMMEDIATE RELEASE
April 15, 2002

GE Industrial Systems Launches New Pharmaceutical Solutions Initiative

CHARLOTTESVILLE, Va.-GE Industrial Systems has launched a new initiative, GE Pharmaceutical Solutions, which brings the quality, manufacturing expertise and support of GE and its partners to pharmaceutical companies and their vendors. GE Pharmaceutical Solutions addresses the business and manufacturing challenges associated with FDA 21 CFR, Part 11, to ensure compliance, increase productivity and lower costs.

The initiative – which includes GE Fanuc Automation as the leading division, GE Cisco Industrial Networks, GE Automation Services, and a number of third-party alliances – offers a comprehensive set of products and services that address needs ranging from system assessment and remediation to complete system validation.

"The FDA compliance process is complex, and a simple cookie cutter approach will not work,” said Kevin Roach, vice president of the global solutions business at GE Fanuc Automation. “GE has developed an innovative set of tools and services that will provide the pharmaceutical industry with complete turnkey solutions to specifically solve 21 CFR Part 11 issues in the manufacturing environment.”

To help companies achieve compliance, GE Pharmaceutical Solutions provides: project planning, quality control and service, quality data collection, real-time information exchange, electronic record keeping, remote monitoring and diagnostics, network security and management, assessment, remediation, and validation.

Furthermore, GE integrates manufacturing experience and Six Sigma tools at the machine and plant-wide levels to improve and control processes in real-time. Proven statistical process control (SPC) software tools take traditional manual inspection, data entry, analysis and reporting and turn them into automated gauging and secured data collection applications.

Other software solutions include change management software for documentation and automation control – which provides audit trails that automatically track significant events as well as logon/logoff, check in/check out, program edits, scheduler results and password changes, and facilitates disaster recovery. The complete GE suite offers turnkey automation from the plant floor to the manufacturing execution system, including the supply chain.

FDA 21 CFR Part 11 provides criteria for acceptance by FDA, under certain circumstances, of electronic records and electronic signatures as equivalent to traditional paper records. These regulations, which apply to all FDA program areas, are intended to permit the widest possible use of electronic technology, compatible with FDA’s responsibility to promote and protect public health.

About GE Fanuc Automation

GE Fanuc Automation North America, Inc., is a leading global supplier of automation solutions and is a joint venture between GE and FANUC, Ltd. of Japan. GE Fanuc products and services include CIMPLICITY® collaborative production management software, nano to high-end PLCs, a wide range of CNCs, motion control, operator interfaces, industrial computers, lasers, and a wide range of integration and customer support services. Headquartered in Charlottesville, Va., GE Fanuc is part of GE Industrial Systems. For more information, visit www.gefanuc.com.

About GE Industrial Systems

GE Industrial Systems spans the globe as an industry leader in integrated industrial equipment, systems and services. The business brings to customers the latest technological products used to distribute, protect and control electrical power and equipment, and provides innovative product and service solutions for commercial, industrial, residential and utility applications.  Headquartered in Plainville, Connecticut, USA, GE Industrial Systems is one of the major businesses of the General Electric Company.

CIMPLICITY is a registered trademark of GE Fanuc Automation North America, Inc. All other trademarks are the property of their respective owners.