Pharma
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 control 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
Johnson & Johnson
Fresenius Kabi
Takeda
Pharmstandard
Krka
Leo Pharma
Zoetis
Pfizer
Merck
Teva
Dottikon
Lonza
Aerie Pharmaceuticals
Sandoz
Novartis
Bionorica
Sotex
GlaxoSmithKline
Pharmathen
Alkermes
Galderma
Alcon
Lek
Capsugel
CSL Behring
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