Schneider Electric and Stelex Release Compliance Strategy For FDA's Electronic Record-Keeping, Signature Rules

Aug 22, 2002, 01:00 ET from Schneider Electric

    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
     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
     "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 or
     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,
 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 or
     This release is submitted for consideration in both print and Web
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SOURCE Schneider Electric