Validation of automated systems--system definition.

A Parenteral Drug Association (PDA) Committee on Software Validation was formed about three years ago to address some of the issues associated with validating automated systems, particularly where all, or part, of the automated system is supplied by outside vendors. A Technical Report that describes a process which emphasizes system definition, a comprehensive system specification, system qualification and ongoing evaluation will issue later this year. The concepts described in this document will be consistent with the PMA's System Development Life Cycle approach which is commonly used for computer system validation. The following article has been developed from the System Definition section of this PDA Technical Report.