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Checklist: prepare your site for qualification

Documents, URS questions, season planning. One page, PDF.

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C3 service catalogue

All services, delivery models and deliverables. PDF.

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Glossary

The words, in one line.

URSUser requirement specification
What the room or unit must do, written before design.
DQDesign qualification
Checks the design meets the URS.
IQInstallation qualification
Checks it is installed as specified.
OQOperational qualification
Checks it works within limits across its range, usually empty.
PQPerformance qualification
Checks it performs under real conditions, usually loaded.
Temperature mapping
A study that finds the warmest and coldest points of a space under defined conditions.
Hot spot · cold spot
The warmest and coldest positions found by mapping. Monitoring probes go there.
Continuous mapping
Enough sensors stay in place to keep proving the whole space is in range.
Calibration
Comparing an instrument with a reference traceable to national standards.
MKTMean kinetic temperature
A single temperature that reflects the thermal stress of a fluctuating profile.
RPResponsible Person
Named person accountable for GDP at a wholesale distributor.
QPQualified Person
Named person who certifies batches under EU GMP.

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