ABSTRACT
The woodpecker analogy sums up the major reason why the U.S. Food and Drug Administration (FDA) has developed requirements for the validation of comput erized systems. Even the best computer software may have errors, hardware may have design flaws, communications may be garbled, and components even tually fail. The FDA is aware of these facts and has taken steps to encourage
pharmaceutical and biologies companies and medical device manufacturers to take steps to ensure that their systems perform properly.
