Validation Management
Qualify. Validate. Maintain.
Show me the validation status of this equipment. Hours later, you're still assembling the answer. Manage IQ/OQ/PQ with status visible everywhere—equipment records, batch records, deviations.
Validation is how you prove it works.
Regulators don't trust your word. They trust evidence. Validation proves that your equipment, processes, cleaning procedures, and computer systems consistently produce the results you claim.
The problem isn't doing validation. It's managing validation across hundreds of pieces of equipment and years of ongoing verification. When an auditor asks "show me the validation status of this equipment," you spend hours assembling the answer.
Why standalone validation tools fall short
Your validation system knows the equipment is qualified. Your CMMS knows when it was last calibrated. Your QMS knows about the deviation last week. Your MES knows which batches ran on it. None of these systems talk to each other.
In Seal, validation is part of the platform. When you qualify equipment, that status is visible everywhere—in the equipment record, in the batch record, in the deviation investigation. When calibration lapses, the equipment is blocked from use automatically.
The validation lifecycle
Qualification establishes the baseline: properly designed (DQ), installed (IQ), operates correctly (OQ), performs as expected (PQ).
Ongoing verification confirms the validated state continues. Calibration, preventive maintenance, periodic review.
Revalidation occurs when changes require re-establishing the baseline.
Process validation
Stage 1: Process design—document the scientific understanding that justifies your parameters.
Stage 2: Process qualification—execute validation batches with enhanced sampling.
Stage 3: Continued process verification—ongoing monitoring of process performance. This is where most organizations fail. CPV requires tracking parameters and quality attributes over time. Seal connects batch data, quality results, and statistical analysis into continuous monitoring dashboards.
Computer system validation
Every computerized system that affects product quality needs validation. System inventory, validation planning, testing, periodic review. GAMP 5 provides the framework; Seal provides execution.
The audit question
"Show me the validation status of this equipment" → One click to complete qualification history.
"How do you ensure ongoing validated state?" → Calibration, maintenance, and periodic review records linked to the qualification.
The answer is never "let me find the binder."
Capabilities