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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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Jeremy Cook
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