Computer validation regulations have increased worldwide by 300 percent since 1991. The FDA, EMEA (European Medicines Evaluation Agency), and other drug regulatory agencies train their field inspectors in the principles of computer validation. This book clearly explains the influences placed upon computer validation by these worldwide GLP and GMP regulations and then helps to integrate good validation techniques into the laboratory or manufacturing environment. Teri Stokes approaches computer validation from three perspectives: the work process manager, the system team, and the system owner