I've heard about verification and validation through lectures, but I'm still not sure about the difference between the verification and validation. What exactly is the difference between verification and validation?
Verification is more of an internal process where project qualities are checked in order to ensure adherence to certain specifications that are determined by project managers or directors. This can also mean that we are verifying if a certain aspect of the project meets regulation standards. Validation is where you are checking if desired qualities are acceptable or not - usually up to consumers but also can be an internal check. In one of my previous roles, we had to complete IQ/OQ/PQ validations for various equipment within our manufacturing facility - the verification is to ensure we are meeting certain plant specifications in the processes, and the validation is "is this doing what we want it to do?"
I had to do verification and validation testing for my Senior capstone in my undergrad. Verification is essentially where you test to see if specific requirements have been fulfilled. This is done with the specifications for the design in mind, not the device's purpose. Validation is done to test those same requirements can be fulfilled for the intended use. My professor differentiated this by verification tests are done to see if we built the device correctly. These tests can be usually done in a laboratory setting, since the requirements are all that matter. Validation tests are done to see if we built the correct device. These are usually done with the device's intended use in mind.
Essentially validation is to make sure the device you’re making is meeting al the customer needs and ensuring all requirements are being met for its intended us.
In Design verification, it is making sure that you are creating the device appropriately, such as if it meeting regulatory standards, safety features, basically that the device passes “tests/checkmarks” for meeting a requirement stated in the validation.
While verification and validation are both elements of the medical device testing process, they serve two very different but equally essential functions. In the simplest terms, verification determines whether the product was built right, while validation determines whether the right product was built.
Design verification is where the manufacturers develop procedures to verify the device design - meaning confirming that the design outputs (reference criteria and evaluate device for proper functioning) meet the design inputs (complete, clear, and non-conflicting requirements relating to the device that address the intended use as well as user and/or consumer needs). From my experience, design verification typically occurs during development. The intention here is to make sure no design requirements are missed. In this section of the design of history file (DHF), the manufacturers identify the design input requirement, methods for testing, the date, and who the test was conducted by.
Design validation is where the manufacturers develop procedures to validate the device design - meaning confirming that under defined operating conditions, batches/units/lots of the device all conform to the same user needs and intended uses. From my experience, design validation typically occurs after development. The intention here is to ensure the product functions to meet its design requirements. In this section of the DHF, the manufacturers identify the design, outline the methods, include the date, and report on who performed the validation.
Does anyone have experience that they could share as a verification/validation engineer?
I think one of my undergraduate professors put it best once when she had said "Validation is did you build the right device, verification is did you build the device right". This essentially boils down to what many others were saying. Validation is seeing if the device does what you intended and does it meet your customers needs while verification means does your device work properly and is it safe without considering working properly to be in the scope of the customer needs. Basically if your customer wanted a toaster validation sees if you can toast bread and verification makes sure you don't get shocked while doing it and it doesn't blow up.
That's a very good question I actually had before too and upon taking Dr. Simon's class from last semester I got the proper response.
So essentially Verification is making sure that all the specs were met from the DID which is compiled from the customer's demands and making sure the device functions under those guidelines. It's to make sure the device itself was designed correctly.
Whereas Validation is experimenting to make sure that the device can perform its intended uses under the conditions it may withstand it's the next step to "validate" that the device is functioning correctly for the real deal.
The way I look at verification and validation is by comparing it to in vitro and in vivo testing. Verification applies to all the research that is done before actual testing. This includes the theoretical information that is expected from the tests. Whereas validation is the actual tests to see if the theoretical information was correct or not. For example, say there is a button programmed into a video game. The verification part is the coding and programming that goes into the system to make the button work. The validation part comes when playing the actual video game to see if the button was programmed correctly to mesh with the game as a whole. Verification and validation is an extremely important process for the success in the medical industry.
Verification and validation are two independent procedures that are used together to ensure that a product, service, or system meets the requirements and specifications it's meant to in order to fulfill its intended purpose. In general terms, verification is the process of determining whether the products documents and designs have met the specified requirements, whereas validation is the process of testing the actual product. However, in order to truly explore the difference between verification and validation it is important to look at the process of both.
The main question to be asked during the verification process is if the product is being built correctly. As previous stated, the verification process will check to see if the software is able to achieve its goals without any sort of bugs or disruptions. This means that it will ensure that the product that has been developed is right or not. For example, if there was an application in which users could enter their details in to subscribe to a clients newsletter, verification testing would be used to verify that the correct data is being captured.
Validation on the other hand asks whether the correct product is being built. This process includes testing the actual and expected product. It checks whether the software product is up to the mark, or in other words has high level requirements. This means that validation will confirm whether the product is able to perform the job it is required to do. An example of a validation test would be testing the submit button from the example before. The application should perform an action whenever a user clicks on the button. Either the users data will be saved, or the correct error message will be displayed.
Verification and validation are two distinct processes crucial to quality assurance in various fields, including software development and engineering. Verification involves evaluating a system or component to ensure it aligns with the specified requirements during or after the development phase. This process focuses on confirming that the product is designed and implemented correctly according to predefined specifications, utilizing static methods such as inspections and reviews. On the other hand, validation entails evaluating a system or component to determine whether it satisfies its intended use or purpose. This process is geared towards assessing whether the final product meets customer needs, emphasizing dynamic testing methods like functional and system testing.
Verification and validation are both process included in the process of quality assurance in manufacturing and research. Verification is when a product is tested to make sure that it meets the design requirements of the project. Validation is testing the product in the aim of seeing if it performs to the project requirements. For example a toothbrush can undergo verification to see if it is designed according to the drawings of the team and uses the correct materials. Then the toothbrush will be undergo validation testing to see if it has the functionality as other toothbrushes on the market. In most cases, we see verification happen at the beginning of a product's development, while validation is something we see towards the end to make sure this product can be distributed to the public.