Verifying and Validating Software in a Regulated Environment - Presentation
Presented at NAFEMS 2016 by William Bryan. The ANSYS, Inc. Quality System is set up to meet the requirements of the International Organization for Standardization (ISO) ISO 9001:2008 as well as the applicable requirements of the U.S. Nuclear Regulatory Commission’s, Rules and Regulations in Title 10, Chapter 1, Code of Federal Regulations, Appendix B to 10 CFR Part 50, “Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants” and Title 10, Chapter 1, Code of Federal Regulations, Part 21, titled "Reporting of Defects and Noncompliances" for reporting and dedication of commercial grade items. For customers who perform analyses for nuclear application, a quality assurance service was developed in the 1970’s which affords customers the ability to purchase software that meets the requirements of the U.S. Nuclear Regulatory Commission (NRC). We use the American Society of Mechanical Engineers (ASME) NQA-1 Standard to accomplish this.