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Validation is required by FDA QSRs and ISO 13485:2003, 2008
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21 CFR 820.75 – Where the results of a process cannot be
fully verified by subsequent inspection and test, the
process shall be validated with a high degree of assurance… |
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ISO 13485:2003 – The organization shall validate any
processes for production and service provision where the
resulting output cannot be verified by subsequent monitoring
and measurement. This includes any processes where
deficiencies become apparent only after the product is in
use or the service has been delivered. |
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So, Validation is confirmation by examination
and provision of objective evidence that the particular
requirement for a specific intended use can be consistently
fulfilled. |
