Computer System Validation (CSV)

Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements. Validation of computer systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records is a critical requirement of electronic record compliance, as described in the FDA 21 CFR 11.10(a) and EMA Annex 11, Section 4.

System validation projects are always carried out by applying a GAMP methodology (Good Automated Manufacturing Practice); internationally recognized as a point of reference to be followed.

Here are some of the types of systems validated following our methodology:

  • ERP: Enterprise Resource Planning covering materials and resources.
  • EDMS: Electronic documentation management systems.
  • EBR: Electronic Batch Record.
  • SCADA, DCS, etc.
  • LIMS.
  • Pharmacovigilance.
  • Clinical trials.
  • Laboratory instrumentation.
  • CAPA systems.
  • Computer systems qualification.

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