Computer systems performing regulated operations shall be validated. Typical examples of such systems are
• Systems that control the quality of product during its development, manufacturing, testing and handling process.
• Systems that create, modify, maintain, archive, retrieve, or transmit data used to prove the safety, efficacy, and quality of product and formulations.
• Systems that provide information on which decisions are made affecting fitness for purpose of the product.
• Systems that create, modify, maintain, archive, retrieve, or transmit records that must be available for inspection by a regulatory agency.
• Systems that provide data or reports that are sent to regulatory agancies.
The dept and scope of the software depends on the category of the software, and the complexity and criticality of the application.