Validation is more ambitious than commissioning. In a validation study the goal is to identify the limits within which a certain system operates correctly. For a certain process it could be to define the temperature range within which the system will perform correctly or the yield of a production step to be optimized. Validation is often the approach we will see in the GMP industry, while smaller labs might find that a final commissioning step is all it takes to move from contraction into operation. Validation is often a very resource heavy exercise, however there are statistical methods published that can reduce the number of tests and still give a firm validation foundation.


Commissioning is a documented process that ensures facilities, systems and equipment are designed and installed as specified and function as expected.


Qualification is a more product-focused process and can be divided into three separate streams: Installation Qualification (IQ: did we get what we asked for?), operational Qualification (OQ: does it work as promised?), and performance Qualification (PQ: does it give the product we expect in our facility?). Qualification ensures equipment and systems function to produce products consistently and correctly.

The best way to decide what needs to be commissioned, qualified and validated is to perform an impact assessment and document the rationales for where the extra effort is focused and why.


If it is plugged in – does the light come on? Are the drawings reflecting the reality of the instrument?


Can the system do what the supplier promised?


Can the system perform in my environment, with my process parameters and deliver the wanted output?

These verification protocols can either be developed from scratch or developed from a subset of the data from the URS requirement database … if right URS strategy has been chosen from the start.


Factory Acceptance Test (FAT) is a quality assurance step that takes place when a piece of equipment or a system is finished and ready for shipment from the supplier. The user might travel to the facility, inspect and test certain aspects before the system is shipped. This happens before commissioning, IQ, OP, PQ and eventual additional validation tests. It is worthwhile to budget for these FAT tests during the building project, especially for more complex pieces of equipment or systems, as many delays and errors can be caught before the system is shipped.


Site Acceptance Testing (SAT) is a repeat of the FAT test, except the system has been packed, shipped, and is not at the costumers site. It is important to document that the system did not get damaged during the journey. Another important aspect is that even if the system worked with the suppliers steam supply, pressurized air and similar utility systems, there might be aspects on the costumer site that will challenge the functionality of the system performance, such as different water quality, hardness of the water, different steam pressure, lesser vacuum or similar. It is helpful to have a representative present from the supplier when the SAT test is performed at the costumer site.