I don't have any industry experience, but I can see how verification and validation can be mistaken for each other. Validation ensures that a certain criterion is reached. That includes compiling any testing that is done into a report that shows that the design has passed or failed. Verification goes through a similar process except that it checks that the inputs equate to the outputs within the DSD. put it simpler terms, verification determines whether the product was built right, while validation determines whether the right product was built.
In my experience with working in research development, verification is a tasks carried out to ensure the developed products efficacy is true to what it registered with the EPA. We would perform test such as shelf life verification which would ensure the products active ingredient is stable and the overall products efficacy over a span of time. Validation of a product in the lab was the process of ensuring the protocol used to generate the product was adequate to reproduce the product by any manufacturing company.
Verification is the process of checking that a software achieves its goal without any bugs. It is the process to ensure whether the product that is developed is right or not. It verifies whether the developed product fulfills the requirements that they have. Validation is the process of checking whether the software product is up to mark or in other words product has high level requirements. It is the process of checking the validation of product.
As stated at the start of the discussion, the main difference between the two is the needs that must be met. Verification focuses on confirming if the design output meets the design inputs and validating that the design has its intended functions and meets consumer needs. Design verification is centered on a layered experimenting process by identifying set requirements that are associated with functionality and safety. With design validation, specific performance testing should be conducted to show the intended use of the device. Tests should include but aren't limited to biocompatibility evaluation, packaging validation, and electrical safety.
In my understanding, validation and verification are distinct processes within product development. Validation entails ensuring that a product effectively meets the requirements and expectations of its customers and users. This crucial step involves external parties, like customers, beta testers, and market researchers, who assess the product's performance. Methods for validation may encompass surveys, interviews, usability testing, and field trials.
On the other hand, verification is about confirming that a product aligns with its design specifications, and it's conducted internally by the product development team. For example, if we liken this to building a house, verification would be akin to checking whether the actual construction matches the original blueprint. This internal process involves tasks like code reviews, unit testing, integration testing, and system testing to ensure that the product adheres to the intended design and functionality. It's important to recognize these two processes as distinct but equally vital aspects of product development to ensure a successful end result.
Why seemingly similar and first-glance, validation and verification are quite different terms. Validation is the process of ensuring that a device meets the predetermined customer needs while verification is the process of ensuring that the physical aspects of the device meet the design specifications. That is, validating when prototypes of devices are presented to the customer, who provides feedback about whether or not the customer's needs are satisfied. If the customer is not satisfied, changes are made and the device is presented to the customer again. This process of validation continues until all or most of the customer needs are met. Verification is ensuring that the physical properties of the device meet design specs, whether that is the dimensions of the device, material properties of the device, etc.
In product development, verification and validation serve as critical, distinct checkpoints to ensure quality and efficacy. Verification addresses the question, "Are we building the product right?" by confirming that the product adheres to specific design requirements through tests, inspections, and reviews. Validation, asking "Are we building the right product?" ensures the product fulfills its intended use and meets customer needs, often involving real-world application and user feedback. While verification is an internal process focused on conformity to design, validation is externally oriented, assessing real-world performance and user satisfaction. Together, these processes form a comprehensive approach to product assurance, with verification confirming proper construction per design specifications, and validation ensuring the end product delivers on its promise to users.
Hello,
While I don't have personal industry experience, I can provide insight into the conceptual difference between validation and verification. These terms are distinct and represent different aspects of the quality assurance process. Verification involves confirming that a product meets specified requirements and adheres to the design specifications. It is a process of evaluating the physical properties, dimensions, and other tangible characteristics of the product to ensure they align with the original design.
On the other hand, validation is the process of assessing whether the product satisfies the customer's needs and intended use. It goes beyond the technical aspects examined in verification and focuses on whether the product fulfills its intended purpose in the real-world context. This involves understanding and confirming that the product meets customer expectations, addresses their requirements, and provides the intended value.
In practice, both verification and validation are integral parts of quality assurance. Verification typically occurs during the early stages of product development, ensuring that the design and manufacturing processes align with the intended specifications. Validation takes place later in the process, closer to or during the product's release, when the emphasis shifts to confirming that the product meets customer expectations and functions as intended in its intended environment. A robust quality assurance process encompasses both verification and validation to ensure a product not only meets design criteria but also satisfies customer needs in the real-world context.
In my industry experience, validation involves ensuring that a product meets the customer's intended use and expectations through testing and feedback. On the other hand, verification focuses on confirming that the product conforms to its design specifications and standards during the manufacturing process. These distinctions are crucial in maintaining product quality and customer satisfaction.
In my experience in the industry, I have seen the the importance and effects of both verification and validation. The first step in the journey of the product is that it is verified to match safety and functionality according to its design. I work with a product that has multiple parts and electrical components. This verification is just as effective as the components that are verified. What I mean is this: even if the component is designed wrong, yet it is the design of the company, it will be verified as functional because it matches its design. Now, validation occurs when the customer receives the product. This is where field service and complaints are very helpful. If a component consistently fails, then a root cause analysis needs to be conducted as to the cause of the failure. Validation occurs by customer feedback, and is a necessary part as to the constant research and development. This drives the updates of the product, which changes the verification protocol, and therefore validation changes.
In industry, I had experience with method validation and verification as part of the work I did on our machines. The main differences between the two is mainly how validation involves ensuring that the product meets our customers' or laboratory's needs which was set before in previous meetings. Verification on the other hand can be a bit more of a tedious process requiring thorough checks as a way to confirm the functionality and reliability of the design and free from critical errors. This is not all done in one round of testing alone but takes multiple evaluations and many documents outlining each test. It tends to be the final step before release for a reason.
Though I don't have industry work experience, from my understanding- verification ensures that a product is constructed accurately and accordingly with its design requirements. To verify compliance with the standards, laws, and physical characteristics specified in the design documents, testing, inspection, and measurement are required. This entails verifying that the device satisfies the required performance criteria, tolerances, material composition, and dimensions in the medical device sector.
On the other hand, the end user's needs and intended use are fulfilled by validating the final product. This requires conducting usability testing, clinical trials, and real-world evaluations to verify the product's efficacy, safety, and usability. Validation is a crucial process in the medical device industry that confirms the gadget satisfies the demands of patients and medical professionals, functions as expected, and serves as the promised health benefits.
@jt63njit-edu I absolutely agree with you. Verification focuses on making sure that the software meets the specified requirements through activities like inspections or even reviews. It is often referred to as static testing in my workplace because it does not involve executing the code but rather checking the documents and design itself. On the other hand, to answer the main question, validation ensures that the end product meets the customer's needs ad requires dynamic testing. Dynamic testing would be running the software in real time or simulated environments. Validation includes actual code execution to confirm software. This is an important difference to note especially in regulation where they are both required to ensure compliance!
Verification vs validation can be tricky to understand sometimes. Sometimes its helpful to view it as a 'what makes sense' in that moment when it comes up to verifying or validating a device. One example I can think of that I've seen at my job is verification the position of bore holes on the 'clevis' component of a medical device, and the validation being for the pull force of the welded assembly.
For the verification, 100% verification was chosen; meaning for each lot, in each sequence-how ever many parts are there, an operator would visually inspect every part using a specific microscope at specific magnification and lighting level. The verification was for verifying that the counterbore hole and the countersunk hole are located on the correct positions of the component. Due to there being a 100% inspection requirement this attribute inspection (attribute being basically does this pass or fail-no numbers are collected) is enough to verify that this feature is being kept to spec. Meanwhile, the pull force wouldn't be able to be validated simply by operators inspecting the weld. Thus a fixture needs to be set up and Pull force tester programmed and methodology developed for pull force testing. All this needs to be validated meaning that it is repeatable for every part that goes through, and does it yield accurate results?
Its a case by case method, but usually the more involved it is, the more likely the process needs to be validated.
In the development phase of product development, the process of verification occurs. This process verifies that the product aligns sufficiently with the requirements in place. The process includes a variety of inspecitions and testing that serve to answer the question of whether the product was created correctly in accordance with the design.
Validation occurs within the later phases of the product development process. The purpose of Validation is to ensure that the final product fulfills the needs of the patients. The process can include activities such as clinical trials to validate that the product can achieve its purpose. This is an essential role in the product development process, as it is the final assessment that determines the success of the product.
