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21 CFR Part 11 Implication in the Bioanalytical Laboratory
As with other laboratory work, bioanalysis produces significant quantities of paper-based data. Many of the areas where paperwork is required have been studied and included into existing software packages, such as laboratory information management systems (LIMS). These systems enable information related to study samples to be entered once and carried through the whole analytical process, to be incorporated into a final report with the results generated. The whole process is subject to electronic signatures, audit trails, etc, making the sample tracking and results generation/manipulation part of the analysis process 21 CFR Part 11 compliant.
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