As mentioned above, the user specifications are usually general in nature. For example, they would say we need a V blender with temperature control. The engineers would take this information and prepare the functional specifications. These would include the material of construction (usually stainless steel), how it was to be turned (ie, wall mounted or on the floor), and all the other technical specifications needed for the production or purchase of the unit. The functional specifications would be transmitted to the equipment manufacturer who would determine the design specifications, that is, how it was to be built to meet the user and functional specifications. Once the equipment is built at the vendors shop the testing begins. FAT should be completed on all major equipment before they leave the vendors’ facility. For example, large items (eg, autoclaves) will have a FAT performed. The purpose of the FAT test is for the vendor to demonstrate that the unit will meet the functions and design requirements specified when the order was placed. Be sure to have the vendor include testing that is applicable to your product, not just the tests that the equipment manufacture knows will pass. Very often the vendor will prepare the FAT protocol. However, it is strongly recommended that the drug manufacturer prepare at least some of the testing so as to be assured that the equipment meets their requirement, not just the vendors. These tests should also include the automation or control systems and software. Examples of some of the tests for a V blender are:
Factory Acceptance Test and Site Acceptance Test
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