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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

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