Software validation is a comprehensive and methodical approach that ensures that a software program does what it’s intended to do and works in your environment as intended. Some software vendors verify that the requirements of the software are fulfilled but do not validate the entire system (network, hardware, software, processing, and so on).

Computer System Validation (CSV) is a systematic approach to verify that computerised systems acting singly or in combination, are fit for intended use, have been properly installed, and are operating correctly. This is an umbrella term that encompasses all types of approaches to assuring systems are fit for use such as qualification, commissioning and qualification, verification, system validation, or other.

Regulations often drive the need to validate software including those required by:

  • The United States Food and Drug Administration (FDA)
  • The Sarbanes-Oxley (SOX) act
  • The European Medicines Agency (EMEA)

Computer System Validation requires that all aspects of the validation are documented formally to ensure that there is proof that the system(s) works as intended in it’s actual environment

A typical CSV lifecycle involves the following phases:

Currently the approach taken to carry out these activities relies heavily on paper based systems such as MS Word and MS Excel where documents are manually walked around for pre and post approval.