PT  - JOURNAL ARTICLE
AU  - Davis, Miles
TI  - Validation of Computer Software in Process Control Applications
DP  - 1986 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 18--24
VI  - 40
IP  - 1
4099  - http://journal.pda.org/content/40/1/18.short
4100  - http://journal.pda.org/content/40/1/18.full
SO  - PDA J Pharm Sci Technol1986 Jan 01; 40
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.