Validation

Verification is usually an internal quality management process that ensures compliance with rules, standards or specifications. A simple way to remember the difference between validation and verification is that validation confirms that “you created the right product”, and verification confirms that “you created the product the way you intended to make it” ^[2] . Another example of a typical verification: testing equipment. Having certain requirements on hand, we conduct a product test and record whether the requirements are met. The verification result is the answer to the question “Does the product meet the requirements?”.

But far from always a product that meets established requirements can be used in a specific situation. For example, the medicine passed all the required tests and went on sale. Does this mean that it can be used by any specific patient? No, since each organism has its own characteristics and specifically for it, this medicine can be fatal, that is, someone (the doctor) must confirm: yes, this patient can take this medicine. That is, the doctor must perform validation: give legal force to a specific application.

Another example: an enterprise produces pipes intended for laying in the ground, in accordance with some TU (Technical Specifications). The products comply with these technical specifications, but an order has been received involving the laying of pipes along the bottom of the sea. Can pipes corresponding to the available specifications be used in this case? It is validation that provides the answer to this question.

You can see that another difference is that verification is always done, but the need for validation may not be available. It appears only when there are requirements associated with a specific application of the product. If a pharmaceutical factory produces drugs, it will only check their compliance with the requirements, and it will not deal with the problems of using specific drugs with specific patients.

Thus, we can state the following:

• verification - it is carried out almost always, performed by the method of checking (comparing) the characteristics of the products with the given requirements, the result is a conclusion about the conformity (or non-conformity) of the product,
• validation - is carried out if necessary, performed by the method of analysis of the specified conditions of use and assessment of compliance of the product characteristics with these requirements, the result is the conclusion about the possibility of using the product for specific conditions ^[3] .

Based on the foregoing, validation should be defined as confirmation based on the presentation of objective evidence that the requirements intended for a particular use or application are precisely and fully predetermined, and the goal has been achieved.