"Since it is impossible to be all inclusive and cover every aspect of the design/validation process@ this document can be used as a basis for preparation of a more comprehensive and detailed plan that reflects the accumulated ""lessons learned"" at a particular company. The following areas are addressed in this document: 1. Contemporary perspective including common validation issues and flaws. 2. A Robustness Validation (RV) process based on SAE J1211 handbook and SAE J2628. 3. Design checklists to aid in such a RV process."