INSTALLATION QUALIFICATION (IQ) OVERVIEW
The following is the purpose of Installation Qualification:
- First, it verifies that the equipment or system delivered and installed is
the same as that specified.
- Second, it verifies that the system is correctly installed.
- Third, it verifies that specific FDA concerns have been addressed.
- Fourth, it verifies that critical documentation is available.
- Fifth, it documents the system for change control purposes.
There is a strong tendency for the IQ to be too long and too complicated. The IQ
of a domestic refrigerator, for example, should be only a single page. This
section will describe the means of fully satisfying minimum requirements.
The purchase order and the client's engineering specifications are the primary
source of information regarding what was ordered. Do not use the manufacturer's
catalog information or manual to prepare this section. we assume the
manufacturer can describe his own equipment, but if a refrigerator was ordered,
we don't want a freezer. Keep this section simple: model numbers and options are
good. A careful system description can deal with many things. If a model 51 is
stainless steel, it is pointless to verify that a unit is both a model 51 and
The manufacturer's manuals are a good source of information for the installation
instructions. Again, be simple, but things like utility requirements,
clearances, ASME codes and relief valves are important.
The FDA has a list of things they want to see (see below). some of these are
guidelines that can be altered, but with additional justification. These
preferences are covered in the individual specifications section.
Critical documentation is just that, critical. The PandID is included here, as
are spare parts lists and operating manuals. The FDA has mentioned a number of
documents they consider important.
Qualification Documentation should be simple: record data from plates or dials
or so on, as a basis for change control..
For a pre-existing system, it is the usual case that there are no current
specifications available. In this case, the IQ review will document the system's
existing condition, as a basis for establishing on-going change control.