Services

Industrial standards and guidelines

We follow these industrial standards and guidelines:

  • validation of the GAMP5 computer system,
  • FDA 21CFR11 requirements for e-signatures and e-records,
  • process modelling based on ISA S88.01.
Tools

We use established universal tools:

  • PLC level: Siemens, others upon request,
  • SCADA: GE iFix, Siemens WinCC, others upon request,
  • production informatics level: MS SQL and Reporting server, MS .NET, GE Historian,
  • with the open concept we are able to integrate the solution into the customer’s environment.
The automation system ensures
  • The advanced SCADA visualisation allows to control all elements of a process (valves/motors, sensors).
  • The use of the ISA S88.01 recipe system ensures a high level of automation and at the same time makes the process highly adaptable and allows good use of the process equipment.
  • The modular hierarchic leadership system concept ensures the execution of the process in various procedure levels (stages, operations, unit procedures, procedures) and consequently the process optimisation and a faster introduction of new products.
  • The user independently creates recipes based on the provided templates which protects their know-how and product.
  • The recipe approval work process is based on e-signatures.
  • The unit procedures run entirely on the PLC-level which ensures reliable operation and fast changeovers between individual steps.
  • The recipe and process execution data, historic data and the Audit Trail provide an extensive database for electronic reporting.
  • The FDA 21CFR11 support is based on Windows protection.
  • The implementation of interfaces to other systems at the PLC level (supply of clean media, safety systems, etc.) and at the information level (MES, KPI).
     
References
Fresenius Kabi
Nektar Natura
CSL Behring
Lek
Sandoz
Merck
Alcon
Heineken pivovarna Union
Teva
Zoetis
Pomurske mlekarne
PepsiCo
Pharmstandard
Lactalis
Meggle
Mlekarna Planika
Galderma
Frutarom Etol
Sarajevksa pivara
Heineken pivovarna Laško
Zott
Leo Pharma
Takeda
Žito
Novartis
Lactosan
Pfizer
Aerie Pharmaceuticals
Alvogen
Sotex
Dottikon
Lonza
Mlekarna Celeia
Pharmathen
Coca-Cola HBC
Krka
GlaxoSmithKline
Grupacija Imlek
Johnson & Johnson
Capsugel
Mlekarna Škofja Loka
Bionorica
Alkermes
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