Which statement about general instrument validation practices is true?

• A. New instruments must be validated by the manufacturer before use.
• B. Instrument validation should be performed by the lab using in-house methods such as side-by-side comparisons.
• C. Validation is not required for new equipment.
• D. Validation can be skipped if the instrument appears to function.

Answer: (B)

Validating a new instrument in your own lab using in-house tests ensures the device actually performs reliably under your specific conditions. The best practice is to conduct validation with methods like side-by-side comparisons, where you run the same samples or controls on the new instrument and on a reference instrument or a validated method. This direct comparison shows whether the new device matches the established standards for accuracy, precision, and consistency within your workflow, reagents, and specimen types. It also helps confirm that the instrument integrates smoothly with your processes and produces results you can trust for routine use. In practice, this lab-based verification is often performed alongside vendor-installed qualifications to establish a complete performance picture in your setting.

Relying solely on the manufacturer’s validation isn’t enough because that validation reflects conditions and reagents from the manufacturer, not your specific lab environment. New equipment must be validated to confirm it works properly with your methods and samples. Saying validation isn’t required or that it can be skipped if the instrument seems to function is unsafe, because hidden issues like drift, carryover, or miscalibration can affect results even when the device appears to be operating.