Validation demonstrates that a method is suitable for its intended purpose. Transfer demonstrates that a second laboratory can execute that validated method and obtain equivalent results. They answer different questions, and one does not substitute for the other.
What validation establishes
- Specificity, accuracy and precision appropriate to the method's purpose
- Linearity and range across the levels the method will actually be used
- Detection and quantitation limits where relevant
- Robustness against the small variations the method will encounter
What transfer establishes
That the receiving laboratory, with its own analysts, instruments and reagents, produces results equivalent to the sending laboratory against pre-defined acceptance criteria. Comparative testing is the usual approach; waivers require a documented justification, not a convenience argument.
Where transfers fail
Acceptance criteria set after the data are in hand; sample sets that do not span the range of routine use; and undocumented differences in equipment or reagent grade between the two sites. A transfer protocol approved before execution prevents nearly all of it.
Reviewed by the named consultant. Last updated July 14, 2026. General information only — not regulatory or legal advice for a specific situation.