ABSTRACT
I. INTRODUCTION As process control systems become increasingly sophisticated, the ability to meet regulatory validation requirements becomes more complex. The objective of this chapter is to provide the reader with an introduction to validation concepts for manufacturing systems and an understanding of the following:
• GMP compliance issues • Validation concepts and principles • Computer-related systems validation concepts • Typical elements necessary for a computer-related system validation proj-
ect plan
It is ultimately the responsibility of each end user to plan and implement a validation that meets the intent of the good manufacturing practices (GMP). The exact method to accomplish validation is not prescribed by regulation. It is important to note that the Food and Drug Administration (FDA) will be interested more in the content and exact implementation of systems validation as opposed to the methodology of that validation. The problems found by investigators tend to be more in the nature of incomplete implementation of a chosen methodology.
