RT Journal Article
SR Electronic
T1 Validation of Computer Software in Process Control Applications
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 18
OP 24
VO 40
IS 1
A1 Miles Davis
YR 1986
UL http://journal.pda.org/content/40/1/18.abstract
AB With the influx of computer technology applications in the pharmaceutical industry, increasing attention has been given to validation of these systems. This paper describes the components of the validation package for a computerized process control system, discussing the role of each component in the package. Functional test procedures which focus on system performance are shown to effectively simplify testing while satisfying the requirements for validation.