Overview
Computer validation regulations have increased worldwide by 300 percent since 1991. Drawing on her practical project experience in pharmaceutical, biotech, and software companies around the world, author Terri Stokes provides you with the tools they need to develop validation practices that fit into their organization's culture and can be integrated into the normal workflow of regulated activities. She clearly explains the influences placed upon computer validation by the worldwide GLP and GMP regulations and then helps to integrate good validation techniques into the laboratory or manufacturing environment.
Synopsis
Computer validation regulations have increased worldwide by 300 percent since 1991. Drawing on her practical project experience in pharmaceutical, biotech, and software companies around the world, author Terri Stokes provides you with the tools they need to develop validation practices that fit into their organization's culture and can be integrated into the normal workflow of regulated activities. She clearly explains the influences placed upon computer validation by the worldwide GLP and GMP regulations and then helps to integrate good validation techniques into the laboratory or manufacturing environment.