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The in-dwelling qualification protocol shall contain depth measures to be carried out for set up, Procedure and performance qualification. By investing time in producing in depth software package requirements, you may prevent costly re-dones and omissions within the later on levels of the development cycle. A software package requirements specific
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The importance of extractables & leachables tests has grown with increased utilization of single-use programs. For this reason, E&L testing is usually a regulatory prerequisite to demonstrate that leachable impurities from plastic elements used in the processing of the medical solution don’t interfere Together with the Energetic pharmaceutical in
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