Computer Systems Validation

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Contact:

Volker Westphal 

Senior Account Manager

Tel.:  49 (69) 797-84530

 westphal.volker@siemens.com

Computer Systems Validation (CSV)

 

The validation of computerized systems is a means to establish evidence that the system involved is suitable for use in a GMP environment. Amongst others, CSV covers the following fields of activity:

  • Manufacturing Execution Systems (MES)

  • Laboratory Information Management Systems (LIMS)

  • Distributed Control Systems (DCS)

  • Programmable Logic Controllers (PLC)

  • Automation System Security

Computerized systems must be validated in accordance with applicable government regulations if they process or store GMP-relevant data or control GMP-relevant processes and thus have a direct or indirect impact on the quality of pharmaceutical products, medical equipment, or clinical studies.