Definition
FAT (Factory Acceptance Test)
A FAT is the acceptance test at the integrator's workshop, executed before shipping an automated equipment to the client site. It validates that the machine, its controller, its HMI and its sequences function in accordance with the contractual FDS and HDS. We run it following a signed protocol covering I/O testing, production sequences, recipes, alarms, safety interlocks, communications with upstream systems (DCS, MES) and documentary deliverables. In a pharma context, FAT also clears non-conformities before transport, where correction cost is lowest. A well-prepared FAT avoids weeks of drift on site. Since 2020, remote FAT (eFAT) has been accepted by Swissmedic and FDA under conditions of streaming and electronically signed execution.
Related
- SAT
- IQ
- FDS
- HDS
- GAMP5
- mise en service
Further reading
Pharma automation commissioning: 2026 guide
Full commissioning cycle for an automated pharma line in 2026: URS, FAT, SAT, IQ, OQ, PQ with GMP/GAMP5 and Swissmedic.
FAT/SAT pharma: hitting GMP milestones in Switzerland
Delivering successful pharma FAT/SAT in Swiss GMP sites: classic pitfalls, checklists and GAMP5-compliant validation files.
MES, ISA-95 and ERP/PLC integration in pharma: a pragmatic architecture for Swiss sites
Pharma MES architecture: the ISA-95 grid, where Werum PAS-X, Siemens Opcenter and Rockwell PharmaSuite fit, and a concrete Swiss case of perimeter re-scoping.