I'm just trying to find out what this exactly means??? Are the three documents (Installation, Operational and Performance) that are mentioned just checklists or tests that are run?
If they are compliance documents its probably meant to be a set of tests to run to assure that the procedures are being followed or are accurate. Not having run tests under pharmaceuticals I don't know...perhaps someone who has run into this can give you more detail.
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The reason why I ask is not related to compliance. Taking out IQ, you are left with OQ and PQ which says:
Operational Qualification: Is when you verify the system functions as it is intended.
Performance Qualification: Is where you verify the system works as the users want it (acceptance testing). In other words, the OQ tests the functional requirements and the PQ tests the user requirements.
Now, after the system is installed, do you write up an OQ document of the actual operational boundaries, or what is expected? If so, is this the same as the PQ documentation?