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