Statistical auditing of toxicology reports.
Statistical auditing is a new report review process used by the quality assurance unit at Eli Lilly and Co. Statistical auditing allows the auditor to review the process by which the report was generated, as opposed to the process by which the data was generated. We have the flexibility to use different sampling techniques and still obtain thorough coverage of the report data. By properly implementing our auditing process, we can work smarter rather than harder and continue to help our customers increase the quality of their products (reports). Statistical auditing is helping our quality assurance unit meet our customers' need, while maintaining or increasing the quality of our regulatory obligations.
Deaton
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Quality Assurance and Statistical Sciences, Eli Lilly and Company, Greenfield, Indiana 46140.
Obenchain
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D003627:Data Interpretation, Statistical; D006801:Humans; D007753:Laboratories / Q000592:standards*; D008330:Management Audit / Q000379:methods*; D012494:Sampling Studies; D014116:Toxicology