The Implications of 21 CFR Part II Guidance Document on Operators of Chromatography Data Systems

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The archival of analytical data, including spectra and chromatograms, has been the subject of a great deal of attention and debate recently as the full implications of the introduction of 21 CFR Part 11 have dawned on organizations regulated by the Food and Drug Administration (FDA). Compliance with the Rule remains somewhat of a moving target. In order to address this situation and assist industry to correctly interpret the demands of Part 11, the US Department of Health and Human Sciences of the FDA has issued a draft guidance document (docket number 00D-1539). The document is primarily intended for regulated science-based organizations. However, it also offers assistance on Part 11 compliance for FDA personnel, as well as computing software vendors serving pharmaceutical and other industries in the regulated environment (Good Manufacturing Practice, GMP; Good Laboratory Practice, GLP etc.). While the document focuses on the maintenance of electronic records and issues such as required retention period and record migration, it also has implications for the acquisition and processing of data, such as that generated through chromatography. In considering potential vendors, operators of chromatography data systems (CDS) should take into account how systems address the issues that this latest draft guidance raises. Likewise vendors need to become familiar with the document to ensure systems ultimately support the customer in achieving compliance.

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LC•GC Europe January 2003.

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