installation qualification: The performance of tests to ensure that the installations (such as machines, measuring devices, utilities and manufacturing areas) used in a manufacturing process are appropriately selected and correctly installed.
Utilities and equipment should be correctly installed, in an appropriate location.
There should be documented evidence of the installation. This should be in accordance with the IQ protocol, which contains all the relevant details.
IQ should include identification and installation verification of relevant components identified (e.g. services, controls and gauges).
Identified measuring, control and indicating devices, should be calibrated on site, unless otherwise appropriately justified. The calibration should be traceable to national or international standards. Traceable certificates should be available.
Deviations and non-conformances, including those from URS, DQ and acceptance criteria specified and observed during installation, should be recorded, investigated and corrected or justified.
The outcome of the IQ should be recorded in the conclusion of the report, before OQ is started.
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