ABSTRACT
As discussed in chapter 46, the FDA has considered
computer systems as equipment that needs to be formally
qualified. The general approach to qualifying a piece of
equipment can be found in chapter 46. All types of
equipment used in or for the purpose of producing or
releasing a pharmaceutical or device product must be
qualified; computers and computer systems are no excep-
tion. The use of computerized control for manufacturing
and quality control has grown substantially over the last
decade. In fact, the FDA guideline on PAT discusses this
technology as it is gaining acceptance in the
pharmaceutical industry.
