ABSTRACT
The development of business requirements, objective evidence, intended use, proper performance, and operating environment are maxims or general rules in an effective CSV program. To be able to develop a computer system, the reason to undertake the computer system implementation is needed. The business requirements provide this information. In addition, the business requirements make available the benefits that the developing organization or its customers expect to receive from the system. The US Food and Drug Administration (FDA) considers software validation as the "confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled." Computer systems used in the manufacturing of regulated products, either control the quality of a product during testing, manufacturing, and handling processes.
