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