The verification is when the tests are created for each specification in the DSD to confirm that the design input equals the design output. For instance, if the device is design to be coated black and it was incorrectly coated, it is already failing one of the verification tests. Design validation is when the design output or the device completed meets the user needs, intended uses and applicable standards. This is crucial to check that the product placed in the market is meeting the customer’s standards or can cause product recalls.

In terms of the Design and Process V&V, they are both similar due to still working to create the same product and must at the end of both still work to meet the user needs. So in terms of the validation of the product at the end of production, the outcome must be the same. However, in terms of the verification process, there would be some differences due to the scale of the process. For instance, within the manufacturing after the design transfer, other items that must be taken into consideration such as equipment to create device, materials and availability. It is important to make sure each output from each equipment meets the input based on the specification requirements.

http://www.mastercontrol.com/newsletter/medical_device/medical-device-design-history-file-0710.html

Hi All,

Verification and validation of a process includes making sure that process and all aspects of it are meeting the correct specifications. As was stated above this would involve ensuring that equipment used during testing is giving accurate results. This equipment, after being verified, would then be used to run the verification test for the device as a whole. Thus there is a large amount of overlap between verification and validation of processes and designs.

-Andrew Nashed

By process, I am assuming you mean any standard operating procedures and policies created by the Quality department. These processes are considered higher level documents, which explain how to perform a Design Validation Process, Product Risk Management Plan, Design Verification Procedure, etc. Specifically for a design verification procedure, it details the steps on creating a protocol, routing the document to a technical authority to review and then to a QA for pre-approval. Next, the protocol is executed, and a report & discussion is conducted to analyze the results, which then gets post approved. This process for a verification, needs its own "V&V" in a way because the process must make sense and be correct for engineers to follow. Each SOP, is essentially dry ran to make sure each step is detailed enough to make sense, so when a new hire enters the company they can refer to the company's SOPs and understand the different processes.

Verification is making sure that the product/ device is functional and performs as it should. It entails testing, inspections, and analysis. Validation is making sure that the product/device is useful and meets the needs of a consumer. It ensures that the product or device has a market and a purpose for existing.

V&V overlap for both the device and the process in that they both have a similar end goal: to make a functional product that will meet the needs of a consumer while following governmental and company guidelines.
From my understanding, verification for a device means that the device must meet the requirements as stated by the FDA or other governing council. Verification for a process ensures that SOP’s and other company guidelines are followed.
Validation for a device ensures that the product addresses a consumer or stakeholder’s need. Validation for a process ensures that a device’s manufacture methods are practical and efficient (both in time and money) for the device being made.

-Michelle F

Luisa gave a very good answer to the question. I will add the while both process focus our the same outcome they are also very different. The design V&V focuses on the design while the process V&V focuses more on the road to the design. it ensures that the SOP is in order and any device of material used that is included in the device is working and functional as well. Making sure your equipment is working is vital to a design process and that reagents have been ordered in a large lot that has been verified to prevent nay future mishaps.

By definition, verification evaulates whether or not product or system complies with a requirement, specification, or regulation, while validation assures that the product meets the needs of the customer or in other words meets the operational needs of the user. I know within my experience, if a new process is replacing a standard one, a verification would be implemented in order to ensure that the new process will have the same outcome as the standard one. With respect to validation, the users establish a set criteria that the new instrument/equipment must meet, such as testing the extremes and nominal conditions of functionality. It is quite common where these two get confused.

Chris

When talking about verification is like asking our self are we building the system right? We always have to consider this question when we are talking bout verification. It is important that the process of the evaluating products of a development phase to find out whether they meet the specified requirements. Now when we are talking about validation we have to ask our self are we building the fight system? This is another question that validation people have to ask themselves since the process of evaluating product at the end of the development process to determine whether product meets the customer expectation and requirements. What make them apart it pretty much that the design validation shall prove the medical device meets the user needs and intended uses. And the design validation is a design controls activity that happens pretty late in the product development process but yet validation is a measure of one of the first activities- defining user needs.

Design verification tests whether each design output meets design input requirements. Therefore, individual design verification test aims to prove that each design output complies with each specification created from the DID. Design validation tests if the design conforms to user needs and intended use under specific operating conditions and risk analysis.
Process validation establishes by objective evidence that a process consistently produces a result or product meeting its predetermined specifications, therefore at the end the outcome should be the same. This involves a series of activities taking place over the lifecycle of the product and process. Process verification must demonstrate that the end product conforms to the requirements and the result are fully verified. If the result of a process cannot be fully verified, the process must be validated.

Although it is easy to mix up the concepts behind design verification and design validation, both of them consist of different aspects that ultimately combine to form part of the Design Control. Design Verification confirms that the design output meets the design input requirements. Thus, it confirms that the design meets the product specifications and it performs as it should. It involves tests, inspections, and analysis of the product. Design Validation ensures that the device meets customer needs and intended uses.
Design and Process V&V go hand-in-hand and are also set apart in different ways. At the end of the entire process of producing a medical device, the validation of both the design and the process overlap and must be the same. The end goal is to create a product that is completely functional and meets customer needs. On the other hand, design and process verification is separate because it makes sure that the SOP is followed. The material to create the product and the equipment used to test the product must be taken into account. It is all part of a dry run of the verification process.

Design verifications confirms design output meets the design input requirement. Design validation establishing by objective evidences that design specification meets the user need and intended use. Design V&V demonstrates at product was design correctly. Process validation means establishing by objective evidence that a process produces a result or product that meets it pre determined specification. Process V&V demonstrates process delivers the final product. The output of process V&V includes reports ,final production documents and completetd designs transfer. Design and process V&V are different but each contributes important element to insure product’s success.

Verification = Inputs = Outputs
Verification is completed after DAD and RA, this document shows the tests that were created for each specification or requirement in the DSD to verify that the design input meets the needs of the design outputs. This document will have a protocol on how the the test plan for each requirement is setup and the report for the actual statistical analysis, outcome and pass or fail status of the test. Validation is when the output of the design meets the user needs and it's intended uses. This document will also make references to the DSD but also to the DID and IFU along with regulations and also materials. This is important to ensure that the outcome of the product does not stray away from the needs of the customer.

In terms of the V&V having overlapping sections, yes that would be when referencing testing for safety and efficacy but also the performance of the device, however they differ in terms of the approach and processes.

Regarding verification and validation themselves, the difference lies in what is being confirmed. Verification is the confirmation that the design output meets the design input requirements. Verification is showing that what the project defined as their requirements of the design came out successful. Validation is the assurance that the device meets the user needs and how it is intended to be used. The importance of validation is simulated use.

Within the V&V process for Design versus Process, there is an overlap but there also exists divides. Both are ensuring a safe and effective device, but at different points of the manufacturing. For Design V&V, it is ensuring that the outputs of the design are consistent with what was specified as an input, as well as ensuring simulated use. For Process V&V, it is confirming that the process is consistent and produces the same results every time it is carried out so that the device will be produced consistently, with the overarching goal for a safe and effective device.

I agree with @julienneniuya and @asimbana that Verification is to confirm that design outputs equals the inputs. That the design numbers/specs set out are accomplished whereas with validation is the confirmation on the end user that the device meets the user needs. When researching industry validation processes, I came across a New York Times article from a couple weeks ago, where a company called Box, Inc. (NYSE:BOX) announced Box GxP Validation, which is an innovative new approach for maintaining GxP compliance in the cloud. Box GxP Validation enables Pharmaceuticals, Biotechnology and Medical Device businesses to develop, validate and operate their GxP compliance standards within Box. As Riju Khetarpal, Managing Director, Box for Life Sciences says "With GxP Validation, companies in regulated industries can eliminate inefficient silos between regulated and unregulated information, and speed up collaboration and innovation". Some capabilities include:

-Exchange clinical content between sponsors, Clinical Research Organizations (CROs), contract manufacturing organizations, and investigator sites;
-Collaborate and exchange regulated content during joint development or M&A activities;
Secure archival of Standard Operating Procedures (SOP) and clinical study documentation;
-Remain compliant with 21 CFR Part 11 requirements by integrating Box with an eSignature provider of choice, like Adobe Sign and DocuSign;
-Leverage Box as a compliant content layer with life sciences ISV and SI partners.

Box customers include: Eli Lily, AstraZeneca, Jazz Pharmaceuticals and Boston Scientific. Overall, I thought it was interesting to think about validation processes and thinking about how these larger life science companies are purchasing products like this. It'll be interesting to see if the larger medical device companies follow suit.

markets.on.nytimesresearch/stocks/news/press_release.asp?docTag=201801181200BIZWIRE_USPRX____BW5496&feedID=600&press_symbol=82956982

I currently work in manufacturing and I see a lot of instances when a design and process needs some form of verification or validation. We use verification activities to test and confirm that product meets the specific requirements of the defined instructions. Typically we have in process checks to verify that specifications have been met during production. We validate to testing and confirm that the product meets the specific requirements of the defined instructions. Processes require validation when the results cannot be measured, or the cost of verifying is too high to justify the need for verification. For example, my company validates the environmental tests for our IVD device.

I found this article that details a process should be validated or verified and describes what it means to be “Fully Verified” or “Fully Validated.”

Labcompare . com /2719-Blog/170873-Manufacturing-Process-Verification-Versus-Validation-Which-Do-You-Need/