NEC BIRMINGHAM
13-14 OCTOBER 2024

Computer System Validation Process (CSV)

Robosol Software UK Limited Stand: H70
  • Computer System Validation Process (CSV)
  • Computer System Validation Process (CSV)
Computer System Validation Process (CSV) Computer System Validation Process (CSV)

It also ensures data integrity, traceability and compliance with regulatory agencies such as the U.S. Food and Drug Administration (FDA-CFR21 Part 11) and the European Union’s Good Manufacturing Practice (GMP – Annexure 11).

In the pharmaceutical industry, any computers (software and hardware) involved in the following processes should be validated; R & D, laboratory lab notebook manual, batch record manufacturing process, analytical testing, stability process and material storage & packaging. Therefore, CSV is a stringent requirement as per national and international guidelines for the pharma industry at large. 

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