Validation plugs regulatory holes

摘要

The pharmaceuticals regulatory-approval process can be a headache, especially the often-times tortuous, complicated, and strict, but changeable, computer and automated-system qualification and validation process. A new analgesic gets automated batch controls approved and meets the U.S. Food and Drug Administration's (FDA) mandate to demonstrate "through documented evidence, that the system or process functions [are] designed with a high degree of assurance."