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