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| Design (Product) Validation |
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Establishing by objective evidence (documented)
that device specifications conform with users needs
and intended use. |
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| Verification |
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Confirmation by examination and provision of objective evidence that
specified requirements have been fulfilled. |
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| Retrospective Validation |
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A validation that establishes evidence that a product or process performs
to its specifications based on a review and analysis
of historical performance data. |
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| Prospective Validation |
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A validation that establishes documented evidence that a product or
process conforms to its specifications prior to
final release of the product or process. |
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