EVS-EN 62381:2012

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.