What is the difference between Verification, Validation and Qualification?
[top] In an LCGC Magazine article by Drs. Ira Krull and Michael Swartz they reference the International Organization for Standardization (ISO) as follows: Validation is confirmation, through the provision of objective evidence that the requirements for a specific intended use or application have been fulfilled whereas Verification is confirmation, through the provision of objective evidence that specified requirements have been fulfilled. They go on to say that if you use a compendial method, you verify and if you a non compendial or original method, you validate. The term Qualification is now reserved for instruments whereas validation and verification are for methods and software. For more details and further explanations see LCGC North America, Volume 23 Number 10 October 2005, Page 1100.
