Maps to
FDA QMSR (Part 820): §820.75
ISO 13485: ISO 13485 §7.5.6
Requirement text
Processes where the output cannot be fully verified by subsequent monitoring or measurement shall be validated.
Atomic constraints
- •Validation protocols must be documented (IQ/OQ/PQ)
- •Process capability must be demonstrated
- •Revalidation criteria must be defined
- •Validation results must be recorded
Evidence signals
- •
FILE_EXISTS
(Process.*Validation|IQ.*OQ.*PQ|Installation.*Qualification|Operational.*Qualification)
- •
CONTENT_MATCH
Does this document describe process validation, installation qualification, operational qualification, or performance qualification?
Audit defense
Process validation for [your product] is documented in [your document ID]. All special processes have been validated through IQ/OQ/PQ protocols demonstrating process capability, with defined revalidation criteria per QMSR 820.75.