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.