Validation

Validation means confirmation by examination and provision of objective evidence that particular requirements can consistently be fulfilled. Validation of a process, or process validation, means establishing by objective evidence that a process consistently produces a result or HCT/P meeting its predetermined specifications.
means confirmation by examination and provision of objective evidence that particular requirements can consistently be fulfilled. Validation of a process, orprocess validation, means establishing by objective evidence that a process consistently produces a result or HCT/P meeting its predetermined specifications.

Source

21 CFR § 1271.3

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Scoping language

The following definitions apply only to this part:

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