PALATINE, Ill. – April 7, 2003 – Electrical industry leader Square D / Schneider Electric has introduced a secure, controller-based system that provides embedded functionality addressing FDA requirements on security, audit trail and version control. The open platform solution combines hardware and software around a flexible architecture that provides pharmaceutical manufacturers with a cost-effective method of securing their automation systems and meeting GxP validation requirements.Pharmaceutical manufacturers have invested heavily in making their factory systems compliant with the FDA’s requirements. The new Schneider Electric solution was developed with assistance from Stelex-TVG., one of the pharmaceutical industry’s leading experts on FDA regulatory compliance. It involves low cost, off-the-shelf hardware and software components for programmable logic controllers (PLCs) and programming software. This integrated solution is configurable for a broad range of pharmaceutical applications, including packaging, process and utilities.The Schneider Electric solution incorporates its MODICON® TSX QUANTUM® PLCs, widely used in the industry, and the latest versions of the company’s award-winning TELEMECANIQUE ® CONCEPT® and ONESTEP GENERATOR™ programming software for PLCs. It provides secure program access, secure network access, document management and audit trail, all key elements in achieving compliance on plant automation systems.“Unlike traditional approaches that handle security and data management at the server level, the Schneider Electric solution manages these functions at the controller level, which is the only way to guarantee access control,” said Mark Liston, Global Sales Director. The company’s solution limits access to authorized individuals, requires authority checks to alter or change a record and uses device checks to determine the validity of a data source. The secure PLC solution is the latest addition to Schneider Electric’s new Validatable SolutionsSM offering, a comprehensive package of enhanced services developed for the pharmaceutical market. These services include GAMP quality documentation, network design and certification, factory acceptance testing for engineering equipment packages, global OEM integration and key partnerships, all supported by dedicated global customer teams.“These teams coordinate our support of the pharmaceutical industry worldwide, enabling us to put Schneider Electric’s considerable muscle to work helping customers maximize the productivity of their assets and people,” said Liston. “Our value to pharmaceutical companies is Schneider Electric’s ability to consistently provide a compliant solution, no matter where their facilities are located in the world.”For more information about Schneider Electric Validatable Solutions for the pharmaceutical industry, call 1-888-SQUARED or visit www.SquareD.com/pharma. Stelex-TVG is a consulting firm providing enterprise-wide compliance solutions to regulated industries in the pharmaceutical, medical device, diagnostic and biotechnology sectors for over 17 years. The firm delivers a comprehensive suite of validation, technology, regulatory and business solutions. Services include program management, quality auditing and assurance, software development, computer system, process, equipment, automation and controls, infrastructure and laboratory validation, as well as system integration, implementation, security and PKI. In addition to technical training and professional education provided through its IACET accredited Stelex University, Stelex-TVG offers ComplianceBuilderTM, the compliance infrastructure solution. Learn more about Stelex -TVG at www.stelex-tvg.com.Schneider Electric, with such leading international brands as MERLIN GERIN®, MODICON®, SQUARE D®, and TELEMECANIQUE®, provides electrical, industrial control and automation solutions for customers in the energy, buildings, industrial and infrastructure markets. Schneider Electric's 65,000 employees worldwide generated sales of approximately $8.3 billion in 2002 through 9,000 sales outlets in 130 countries.
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