RT Journal Article
SR Electronic
T1 Validation of Automated Systems—System Definition
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 156
OP 160
VO 46
IS 5
A1 Robert W., Stotz
A1 Kenneth G., Chapman
YR 1992
UL http://journal.pda.org/content/46/5/156.abstract
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.