• process control using PLC S7-1500 and SCADA GE iFix,
  • compliance with 21CFR part 11,
  • SCADA in English or the local language,
  • Audit Trail and electronic signatures,
  • PDBM recipes / reports.

Documents:

  • qualification documents (Master plan, IQ, OQ, FAT, SAT),
  • user documentation.
  • Material and welding documentation
References
Roche
Lonza
Takeda
Krka
Alvogen
Bayer
PepsiCo
Novartis
Heel
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