SPADA Docs

( kk ) Test Portion .—A quantity of subsample or member of a sample set that is taken for

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analysis by the method.

( ll ) Test and evaluation (T&E) .—A process by which a system or components are tested and 1033 results analyzed to provide performance related information. The results provide information to 1034 identify risks, empirical data for validation, and assessment of technical performance, 1035 specifications, system maturity, and suitability for intended use. 1036 ( mm ) Validation .—The establishment of the performance characteristics of a method and 1037 provision of objective evidence that the performance requirements for a specified intended use 1038 are fulfilled [ISO 16140-1:2016 (49)]. 1041 This work was cofounded by Defense Biological Product Assurance Office, JPEO, JPL Enabling 1042 Biotechnologies and DoD DUSA T & E. We would like to thank Tom Slezak (KPATH 1043 Scientific, LLC) for many valuable comments on the manuscript, Teresa Ponio for help with 1044 graphics and Sharon Brunelle for editorial help. 1039 1040 10.0 Acknowledgements

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11.0 References

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(1) Deputy Secretary of Defense (2015) Memorandum: Implementation of the

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Recommendations in the Comprehensive Review Report: Inadvertent Shipment of Live

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Bacillus anthracis (Anthrax) Spores by Department of Defense. Available from:

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https://dod.defense.gov/Portals/1/features/2015/0615_lab-stats/docs/DSD-Memo-

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Implementation-of-Recommendations-in-Comprehensive-Review-Report.pdf

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