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machines, process, packaging, storage, distribution and supply chain management.

"Subject Matter Experts are defined as those individuals with specific expertise and responsibility in a particular area or field (for example, quality unit, engineering, automation, development, operations). Subject Matter Experts should take the lead role in the verification of manufacturing systems as appropriate within their area of expertise and responsibility." --ASTM E2500 §6.7.1 and §6.7.2.

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