The difference between verification and validation
Verification and validation may seem similar, but they serve distinct purposes in product development.
Present in our action plan
At Biocult we operate according to a set step-by-step development plan. Both ‘verification’ and ‘validation’ are present in our action plan, but in completely different stages of the process. This makes perfect sense considering that it concerns 2 different sub-processes. Verification handles the confirmation of the design of an IVD test and mitigates the risk to proceed with the relatively expensive manufacturing of validation batches to perform the validation studies. Validation, on the other hand, confirms that the developed and manufactured product meets the stated requirements.
Read more about our verification and validation services.
The definition of validate versus verify
First of all, the definitions of the words verification and validation. To verify is: “to establish the truth, accuracy, or reality” whereas to validate is “to recognize, establish, or illustrate the worthiness”. Verification is part of our Phase 2: testing the design of an IVD test to ensure that a test is optimal for production. After the verification phase the design is under change control (locked). In the event that for whatever reason an alteration should take place in the design, the product needs to be re-verified to a certain extent, depending on the change. By skipping the verification phase one would risk producing an entire batch of inferior IVD tests, not to mention the financial consequences.
Validation is done in Phase 3. In this phase of the production process the correct performance of the IVD test is checked and subsequently validated; a final check on the different technical and clinical aspects. In Europe analytical performance testing is part of the validation phase. Analytical performance studies indicate that the end product meets the regulations of the new IVDR standard. Our complete process can be found in our dedicated blog : “The process from A to Z”.
Development phases
The definition of verification versus validation
Verification and validation can be confusing because both involve systematic testing and the generation of objective evidence. To make things worse, terminology can also vary between industries, standards, and regulatory frameworks.
From our perspective, verification and validation are complementary activities within the IVD design and development process, but they address different questions.
Frequently asked questions
Verification provides objective evidence that design outputs meet specified design inputs, requirements and predefined acceptance criteria. Depending on the device and its development stage, verification may include analytical, instrument, stability, usability or other studies, where these are needed to demonstrate conformity with predefined requirements.
Following design release, subsequent design changes are managed through the applicable change-control process. Where a design change could affect previously verified requirements, the relevant verification activities may need to be repeated, supplemented or otherwise reassessed.
Validation evaluates the final product in relation to its intended purpose and intended users, under defined conditions of use.
For IVDs, verification and validation are closely linked to the evidence needed to demonstrate that the device is suitable for its intended purpose. Under the IVDR, performance evaluation plan provides the regulatory framework for establishing the evidence supporting the safety, performance and intended purpose of the device.
The IVDR performance evaluation considers three key elements:
- Scientific validity
- Analytical performance
- Clinical performance
Together, these elements contribute to the overall body of evidence supporting the intended purpose of the IVD.
Verification services
- Verification of design outputs against predefined requirements and acceptance criteria
- Analytical performance verification, where applicable
- Assay lot verification against design specifications
- Stability studies supporting shelf-life claims
- Traceable evidence linking outputs to design inputs
- Documentation supporting Design history file and regulatory submissions
Performance evaluation & validation services
- Analytical performance verification of the final assay according CLSI guidelines
- Clinical performance studies, where required
- Scientific validity studies, where applicable
- Stability studies supporting shelf-life claims
- Manufacture and release of validation lots
- Support for performance evaluation and clinical evidence generation
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