Monitoring system qualification checklist
IQ/OQ/PQ points for a continuous temperature monitoring system, including the failure modes that are usually missed.
18 items · Based on WHO Technical Supplement 16, EU GMP Annex 11, EU GDP chapter 3
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Installation (IQ)
Operation (OQ)
Performance (PQ) and handover
General technical guidance written against the cited sources. Adapt it to your procedures; it is not a substitute for the applicable standard or a qualified reviewer's judgement.
Background reading
Qualifying a temperature monitoring system
Installation checks, functional tests covering alarm and failure modes, and a performance period in routine use, plus the software validation underneath.
What a continuous temperature monitoring system must do
Capture at an appropriate interval, alarm reliably, store data securely with an audit trail, and keep working through power and network failures.
Computerised system validation for monitoring and mapping software
Software that produces GxP records must be validated for its intended use: requirements, risk assessment, testing, audit trails, access and change control.