ABSTRACT
As seen in Chapter 14, one theme common to all good manufacturing practice (GMP) computer directives from regulatory authorities is that company management has the responsibility to be in control of computerized systems that are critical to the safety, efficacy, and quality of medicinal product. The GMP directives suggest that the mechanism for management to exert this control is through the development and implementation of policies and standard procedures. Writing policy is not enough, however, and inspectors look for evidence of how personnel are trained on policy and procedures for computerized systems and how compliance is monitored.
