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
Leo Pharma
Nektar Natura
Pharmathen
Novartis
Pharmstandard
Sotex
Alvogen
Heineken pivovarna Union
Bionorica
Pomurske mlekarne
Galderma
Mlekarna Škofja Loka
Coca-Cola HBC
Sarajevksa pivara
GlaxoSmithKline
Sandoz
Lonza
Aerie Pharmaceuticals
Krka
Zott
Dottikon
Takeda
Heineken pivovarna Laško
Alcon
Meggle
Grupacija Imlek
CSL Behring
Frutarom Etol
Teva
Capsugel
Merck
Fresenius Kabi
Lactalis
Žito
Lek
Pfizer
Mlekarna Planika
Zoetis
Alkermes
PepsiCo
Lactosan
Johnson & Johnson
Mlekarna Celeia
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