Computerized System Validation - System Requirements

System Requirements

Documented system requirements are required for CSV as they clearly stipulate the intended use of a computer system application. System requirements are gathered and documented in the system definition phase. System definition artifacts that reflect these requirements can include, but are not limited to, the following:

• User Requirements Specification: Details each feature of the system.
• Hardware Requirements Specification: Minimum hardware required to support the system.

The formal definition of validation from the US Food and Drug Administration (FDA) is:

“Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.” (Source: FDA Guidelines on General Principles of Process Validation, 1987) you fool