October 2007, Sunnyvale, CA—Dionex Corporation has released a new edition of Technical Note 54 (TN 54), Using Chromeleon Chromatography Management Software to Comply with 21 CFR Part 11 . With screencaptures from the current version of Chromeleon, TN 54 lists each relevant section of 21 CFR Part 11, and describes in detail how Dionex’s software facilitates compliance. The document is available as a PDF at www.Dionex.com. The U.S. Food and Drug Administration established 21 CFR Part 11 and published the rules in the Federal Register on March 20, 1997 to define requirements for electronic documents in lieu of paper records. In addition to specifying the system elements and controls necessary in the software to ensure validity of electronically stored records, the law also specifies the use of certain user-implemented procedures. Chromeleon fulfills the software requirements and simplifies the implementation of these procedures, reducing the regulatory burden on the laboratory. To help laboratory managers and administrators determine how the rule applies to any given laboratory, the FDA has issued a number of guidance documents available at www.FDA.gov. Dionex (NASDAQ:DNEX) is a global leader in the manufacturing and marketing of liquid chromatography and extraction systems, consumables, and software for chemical analysis. The company's systems are used worldwide in environmental analysis and by the life sciences, chemical, petrochemical, food and beverage, power generation, and electronics industries. Our expertise in applications and instrumentation helps analytical scientists to evaluate and develop pharmaceuticals, establish environmental regulations, and produce better industrial products.
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