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(b) Reprocessing shall not be done without the evaluate and approval of the standard Manage device.These kinds of calculations shall both be done by a person man or woman and independently verified by a second particular person, or, In case the generate is calculated by automated devices underneath § 211.sixty eight, be independently confirmed by

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Reviewers/Approvers may perhaps delegate authority to a different suitably capable human being to critique/approve information, as relevant.can be a raw content, an intermediate, or an API that may be Utilized in the production of an API and that is integrated as an important structural fragment to the structure with the API.The requirement for cor