This International Standard defines procedures and specifications for the Factory Acceptance
Test (FAT), the Site Acceptance Test (SAT), and the Site Integration Test (SIT). These tests
are carried out to prove that the automation system is in accordance with the specification.
Engineering and manufacturing activities prior to these tests are not covered by this standard.
For application in the pharmaceutical or other highly specialized industries, additional
guidelines (for example, Good Automated Manufacturing Practice (GAMP)), definitions and
stipulations should apply in accordance with existing standards, for example, for GMP
Compliance 21 CFR (FDA) and the Standard Operating Procedure of the European Medicines
Agency (SOP/INSP/2003).
The description of activities given in this standard can be taken as a guideline and adapted to
the specific requirements of the process, plant or equipment. A typical sequence of activities
and events is shown in Figure 1, and their relationship are shown in Figures 2 and Figure 3.