Abstract
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.
- Received September 26, 1985.
- Accepted November 10, 1985.
- Copyright © Parenteral Drug Association. All rights reserved.
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