"Validation" Or "Qualification" - What's The Difference?

By Praveen Bezawada-Joseph, Thermo Fisher Scientific

What is the difference between qualification and validation? This question comes up frequently with both internal and external clients. 

For those studying, manufacturing, or experimenting with delicate pharmaceuticals and biological samples, the importance of sample storage and accurate temperature monitoring is well known. From a qualification and validation perspective, the equipment and processes used for shipping, storing (whether refrigerated storage or ultra-cold storage), and other services must comply with the products’ requirements throughout the chain of custody.  The terms validation and qualification are used interchangeably and loosely at times. In this article, we’ll look at the true difference between the two, and why they are both important components in managing your valuable biological material.