SAN JUAN, Puerto Rico, June 3 /PRNewswire/ -- Complying with stringent
federal requirements for electronic record-keeping in pharmaceutical plants
extends beyond the factory floor to include environmental and utility systems,
according to experts at the PharmRx 2002 Regulatory Compliance Forum.
Sponsored by Schneider Electric and Intellution, two of the world's
largest suppliers of industrial equipment and software for industry, and FDA-
compliance expert Stelex, Inc., the forum was attended by more than 100
manufacturing professionals from Puerto Rico's more than 50 pharmaceutical
plants. The island is a major manufacturing center for pharmaceutical
companies from around the world and attendees included representatives from
Merck and Company, Pharmacia, GlaxoSmithKline, Fluor, Lilly, Pfizer, Wyeth,
Bristol-Myers Squibb, Abbott, Searle, and AstraZeneca.
Experts discussed the impact of the FDA's 21CFR part 11 regulations
governing electronic records and signatures on the pharmaceutical
manufacturing floor, how the regulations are being interpreted and how
agencies are enforcing the regulations. As plant systems become more
automated the impact of this regulation continues to grow. The regulations
are part of the FDA's efforts to assure consistent manufacturing quality in
production of pharmaceutical products.
"How regulations are interpreted is a moving target in any regulated
industry," explains Stephen Larson, Schneider Electric Global Marketing
Manager. "This rule dates back to 1997 and yet many of our customers are just
now feeling a big impact on their business. The industry has a tremendous
need to keep up to date on how regulations are being interpreted, and how
those interpretations impact the manufacturing process."
"To hear from many different sources of information at one event is very
valuable in understanding the complexities of the new electronic record-
keeping guidelines and what it means to our plants," said Grant McDonald,
Senior Electrical Engineer, Pfizer, Inc. "Not only is this a critical issue
for our industry, but it also presents a new opportunity to further improve
An international management team with deep pharmaceutical industry
experience was formed in 2001 by Schneider Electric to oversee the company's
global pharmaceutical initiatives, which include solutions to simplify
regulatory compliance, equipment validation and asset management.
Schneider Electric is a world leader in electrical distribution,
industrial control and automation products and services, integrating a
powerful family of brand names -- MERLIN GERIN(R), MODICON(R), SQUARE D(R) and
TELEMECANIQUE(R) -- into a global offering. The company had 2001 sales
revenues of nearly $9 billion (U.S.) and employs 61,000 people in
130 countries. Learn more about Schneider Electric at
www.schneider-electric.com or www.SquareD.com.
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SOURCE Schneider Electric