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
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.
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SOURCE Schneider Electric