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What Is Re-validation? When Is Re-validation Required? |
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Answer» Re-validation is needed when a previously-validated method undergoes changes sufficient to merit further validation ACTIVITIES and documentation. It usually involves performing a subset of the original validation experiments. Re-validation can be full or PARTIAL, as driven by the extent of the method changes. Examples of such changes would be USE of different sample matrix, addition of new analytes, or CERTAIN alterations of method PARAMETERS. Re-validation is needed when a previously-validated method undergoes changes sufficient to merit further validation activities and documentation. It usually involves performing a subset of the original validation experiments. Re-validation can be full or partial, as driven by the extent of the method changes. Examples of such changes would be use of different sample matrix, addition of new analytes, or certain alterations of method parameters. |
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