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
Scoping language
The following definitions apply only to this part: