Monitoring and maintaining quality in the laboratory: keys to scientific validity and regulatory compliance

By Doug Winters

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Confidence in the quality and consistency of analytical data are integral to regulatory compliance and success in the marketplace. Assuring the accuracy of the data is a result of several components including documented method validation processes, adherence to applicable regulatory mandates (e.g., GLP) and stringent laboratory quality control procedures. Although the basic components and processes that comprise an effective analytical program are well known, the more specific standards, guidelines, and quality practices are less understood. In addition to regulatory guidelines, the validity of the data is a result of adherence to sound scientific and organizational practices.

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