There are two primary objectives for computer system validation. The first is to obtain a high degree of confidence that a system will consistently perform according to critical functional requirements and system specifications. The second is to establish documented evidence of the first objective, in accordance with company policy and all other current applicable good practice regulations and guidelines.

The recognised approach to validating complex computerised systems is in accordance with GAMP 4 (Good Automated Manufacturing Practice), which categorises individual hardware and software components, assesses the general risk of component failure and recommends the appropriate level of validation, following a System Development Life Cycle.