SMB Validation

Government regulations and guidelines often use the words "validate" and "verify," but what's the difference?

Answer; In practical terms not very much.

FDA's definition:
FDA regulations state validation is, "Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes." For control systems, that means the system owner must establish and follow a written methodology that proves its control systems do what they are purported to do. If changes in production requirements require control system changes, the owner must preserve proof of system validation before the changes and preserve new proof of system validation after the changes are implemented.
Legal implications of control system validation come into play when an unsafe condition is brought to the attention of government regulators and investigation reveals the control system isn't doing what it's supposed to do. Depending on the severity of the violation(s), warning letters, monetary fines, production shut downs, product recalls, and/or legal prosecution are all regulatory agency options.

Verification defined:
Among dictionary definitions of verification are, "A confirmation of the truth of a theory or fact," and "A determination or testing of the truth or accuracy of, as by comparison, investigation, or reference." The point is, semantics don't represent a legal argument. Whether it's validation or verification, it's important control systems do what they are supposed to...every time.