PT  - JOURNAL ARTICLE
AU  - Robert W., Stotz
AU  - Kenneth G., Chapman
TI  - Validation of Automated Systems—System Definition
DP  - 1992 Sep 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 156--160
VI  - 46
IP  - 5
4099  - http://journal.pda.org/content/46/5/156.short
4100  - http://journal.pda.org/content/46/5/156.full
SO  - PDA J Pharm Sci Technol1992 Sep 01; 46
AB  - 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.