We develop automation engineering solutions and Computer System Validation (CSV).

Commissioning assistance (FAT&SAT)

  • Issue and execution of Installations qualification (IQ) and Operational Qualification (OQ) protocols according to GAMP guidelines
  • Issue and updating of Software design specifications, for SCADA interface and PLC
  • Issue of Risk Analysis document
  • Compliance check of systems to 21CFR Part 11 and Annex 11
  • Issue of Validation Plan and Qualification strategy

Verona – Via della Valverde 3 
CAP 37122 – Pec:
P.IVA 04904590231