Verification and Validation

Verification and Validation (V&V) are critical steps in the assay design to prove that your product meets its requirements and specifications and that it fulfills its intended purpose. Both V&V are critical phases of your Design History File. This Design History File is part of the technical file of your product and above all essential to be FDA registered or CE marked. We can avoid delay in your product launches, because of our ample knowledge on and expertise.

Product validation - Future Diagnostics

The Food and Drug Administration (FDA) and EU Directive 98/79/EC have set the regulations for all steps in the manufacturing procedures and the criteria for compliancy testing. They also have the authority and responsibility to perform inspections and audits to verify that the manufacturer complies with the relevant regulations. As an accredited company, and together with our Quality Control and Quality Assurance, we follow strict procedures based on the ISO13485 and FDA standards.

Erlenmeyer lab flask measuring cilinder

Verification

Aim is to verify the assay designs, confirm by examination and provision of objective evidence that specified requirements have been fulfilled. Produced verification lots using R&D documentation are benchmarked against the design requirements. In addition, we will initiate accelerated stability studies for indicative shelf life data.

Future Diagnostics has a strong sense of responsibility. Future Diagnostics' members have much flexibility and are quick learners. - IVD instruments manufacturer

Validation

We will perform a technical validation and (accelerated) stability studies of the assay. At the manufacturing location, lots will be produced and QC released. They will be labelled for Investigational Use Only (IUO) – to be used for technical and clinical validation. At Future Diagnostics, we will perform a technical validation according to CLSI guidelines, which will be documented in appropriate reports complying with ISO 13485.

The terms verification and validation are often mixed up

Two different stages in the IVD product development process. To clarify this we explain the differences in a blog for you to read and understand.

Here's the link