Schneider Electric and Stelex Release Compliance Strategy For FDA's Electronic Record-Keeping, Signature Rules
PALATINE, Ill., Aug. 22 /PRNewswire/ -- Schneider Electric, the world's largest manufacturer of electrical distribution, industrial control and automation products and systems, and Stelex-TVG Inc., leading consultants to FDA-regulated industries, have released a joint white paper to assist their pharmaceutical, medical device and diagnostic customers in achieving compliance with 21 CFR 11, the FDA's rule on electronic records and signatures. The white paper covers Schneider Electric's existing automation hardware and software product lines, which are widely used in pharmaceutical plants. Products addressed in the paper include the MODICON TSX QUANTUM(TM) and MOMENTUM(R) processors and I/O modules, as well as CONCEPT(R), ONE STEP LINK(TM) and ONE STEP GENERATOR(TM) programming and SCADA software. Additionally, Stelex evaluated upgrade paths for COMPACT(R) 984, 984 (800 Series I/O) and MODSOFT(R) legacy products. "As the FDA's interpretation of 21 CFR 11 evolves, we believe that it must eventually get to the real source of plant automation data, the programmable logic controller," said Stephen Larson, Global Pharmaceutical Marketing Management for Schneider Electric. "This white paper will help our customers achieve compliance on their legacy systems, as well as drive our product development efforts to create new products that are compliant right out of the box." "Anyone involved with FDA compliance will find this white paper very useful. It provides the pharmaceutical industry with a tangible direction in meeting the regulatory requirements of 21 CFR 11," said Daniel Matlis, Director of Business Development, Stelex Inc. "We're pleased to be working with Schneider Electric in this important effort to translate federal standards to the actual equipment working in pharmaceutical plants," Matlis added. "We've been impressed by their depth of commitment to the pharmaceutical industry." According to Steven Pogrebivsky, a Stelex principal and one of the paper's authors, one of the biggest challenges facing pharmaceutical companies is "how to make the programmable logic controllers and software used to develop PLC programs compliant with the federal regulations for electronic record keeping and electronic signatures. "The goal of this white paper is to specifically address these regulations and provide detailed guidance for customers using Schneider Electric's automation hardware and software," he said. "These suggestions will assist customers with existing and future installations to bring their operations into compliance with 21 CFR Part 11 regulations." To download a copy of the compliance white paper, go to www.SquareD.com/pharma or www.stelex.com. Stelex, located in Bensalem, Penn., has been a provider of quality solutions to FDA-regulated companies for over 15 years. Stelex consultants command a thorough understanding of federal regulations and industry accepted software development standards. Stelex has the proven ability to assist corporations with Quality Auditing Services, System Development, e-Enterprise solutions, System Validation Services and Training. The company is focused on providing timely and comprehensive solutions within ever-changing technological and regulatory environments. Schneider Electric is the world leader in electrical distribution, industrial control and automation products, systems and services. The company has integrated a powerful family of brand names into a truly global offering, including MERLIN GERIN(R), MODICON(R), SQUARE D(R) and TELEMECANIQUE(R). With 2001 sales revenues of approximately $8.7 billion (U.S.) and employing 61,000 people in 130 countries, Schneider Electric serves about 98 percent of the world's population. Learn more about Schneider Electric at www.schneider-electric.com or www.SquareD.com. This release is submitted for consideration in both print and Web publications. MAKE YOUR OPINION COUNT - Click Here http://tbutton.prnewswire.com/prn/11690X52557077
SOURCE Schneider Electric
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