Validation (IQ/OQ/PQ)
Validation is the documented process of proving that a monitoring system consistently performs as intended, following IQ/OQ/PQ protocols.
What is Validation (IQ/OQ/PQ)?
Validation is the documented process of demonstrating that a system, process, or method consistently produces results meeting predetermined specifications. For monitoring systems, validation follows three stages:
IQ (Installation Qualification): Verifies the system is installed correctly per manufacturer specifications.
OQ (Operational Qualification): Tests that the system operates within specified parameters under all expected conditions.
PQ (Performance Qualification): Confirms the system performs reliably in the actual production environment over an extended period.
Why It Matters
Regulatory standards (FDA, EU GMP, WHO) require validated monitoring systems. An unvalidated system — no matter how technologically advanced — cannot be used for compliance purposes. Validation provides documented proof that your monitoring system is fit for its intended purpose.
Frequently Asked Questions
What is the difference between calibration and validation?
Calibration verifies that a single instrument reads accurately by comparing it against a known standard. Validation verifies that the entire system (sensors, software, cloud platform, alerts) works together correctly in your specific environment. Both are required for compliance.
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