Creation and Implementation of a Computer Validation Program *

Abstract

Computer validation programs should be developed and implemented to ensure that systems and programs perform their intended functions. The process of computer validation is broken down into ten components: administration, requirements, design, testing, operation, security, maintenance, change control, record retention and periodic review. Company guidelines and government regulations also must be considered. Implementation of a validation program involves creating awareness, providing training and education on an ongoing basis, and developing a method of auditing to determine level of compliance and enable appropriate adjustment. In addition, it is recognized that responsibility for a system ultimately rests with the end-users.