Dedication of Commercial Grade Design and Analysis Software - White Paper

"Until recently, quality processes known as software verification and validation were typically used as qualification of commercial grade software in many software quality assurance programs. Many believed that commercial grade dedication was not an option for complex items such as computer programs. Although discussed in terms of plant structures, systems, and components in 10CFR21, the Nuclear Regulatory Commission (NRC) concluded that design and analysis software could meet the definition of a commercial grade item in the U.S. NRC Safety Evaluation Report (SER) of Topical Report.

In this report, the NRC noted that existing software quality assurance practices that rely on verification and validation alone may not be sufficient to accept commercial grade computer programs for use in safety-related applications. The NRC emphasized that commercially produced computer programs used for safety-related design and analysis are considered to be safety-related, and safety-related items must be either designed and manufactured in accordance with a quality assurance program that meets the requirements of Appendix B to 10CFR50, or dedicated for use in a safety-related"