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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.

Specified Equipment

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 stainless steel.

Correct Installation

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.

FDA Requirements

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

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.

System Data

Qualification Documentation should be simple: record data from plates or dials or so on, as a basis for change control..

Pre-Existing Systems

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.