Key takeaways
Short answer: Validation proves a process can consistently produce in-spec output. Verification confirms a specific batch did. Auditors expect both, with separate documentation. See also Overall Process Effectiveness (OPE).
Validation answers: does this process, run as documented, consistently produce output that meets specifications?
Verification answers: is this specific batch or unit within spec?
DQ → IQ/OQ/PQ → continued process verification (CPV). Validation establishes; verification maintains.
1. Verification labeled as validation. Audit findings result.
2. Validation never revisited. Process drift unnoticed.
3. No documented validation rationale.
4. Verification without validated process. Out-of-spec finds without clear corrective path.
Process performance shows up in OEE Quality. Validated processes with verification monitoring keep Quality stable.
Fabrico's OEE module supports SPC for continuous verification and stores process parameters with audit trail for validation documentation.
See how Fabrico captures this automatically — explore OEE for manufacturing or book a demo.
No. SPC is continuous verification.
After major changes or per regulatory requirement.
Quality and engineering jointly.
Documented validation lifecycle: DQ, IQ, OQ, PQ, CPV.
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