Computer System Validation is the technical discipline that companies use to ensure that each Information Technology application fulfills its intended purpose. Stringent quality requirements in FDA regulated industries impose the need for specific controls and procedures throughout the Software Development Life Cycle (SDLC). Evidence that these controls and procedures have been followed and that they have resulted in quality software (software that satisfies its requirements) must be documented correctly and completely. These documents must be capable of standing up to close scrutiny by trained inspectors since the financial penalty for failing an audit can be extremely high.
