IQ / OQ Documentation
Installation qualification (IQ)
The installation qualification (IQ) is the documented proof that the equipment meets the requirements placed on it in terms of identity, conformity to guidelines, and documentation.
In this qualification phase, special focus is placed on the technical documentation, whose scope within the design qualification (DQ) must be described precisely and prepared by the supplier.
Functional and performance qualification (OQ)
The functional qualification (OQ) ensures that the machines work as planned and their proper function is guaranteed throughout the range of process-critical parameters.Functional qualification occurs after installation qualification is successfully completed.
To check the pre-specified functionality of all of the equipment’s components, test processes are worked out and corresponding acceptance criteria defined ahead of time.
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