Want to get your product CE marked or FDA Approved?
Outsource Verification & Validation of your Immunoassay or Molecular Test to Future Diagnostics
Verification and Validation (V&V) are critical components 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 in the entire process of product registration. 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.
Verification of your Assay
Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. (…) Verification is a key quality assurance technique.*
Validation of your Assay
Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. (…) Validation follows successful verification.*
Verification: design output = design input?
The nature of verification activities varies according to the type of design output (quantitative, qualitative, multiplex, etc.). We will design the required procedures for your product. Typical verification procedures involve tests devised specifically to ensure that your product meets the initial design requirements, specifications, and regulations. The results of these tests are used to evaluate whether your product is in accordance with these criteria.
We will produce and release R&D verification lots of the assay for you. This is done in close collaboration with our manufacturing staff. After success production of the verification lots, the verification and stability studies are started. In the meantime, the production process is transferred from R&D to the manufacturing site. Finally, the Verification report and (interim) Stability report are produced.
In case Future Diagnostics will be the final manufacturing site, we will write a Technical Transfer Plan with input from R&D, QC and MFG. This plan will be reviewed and approved by both you and us. In all other cases, the Transfer and Process Validation Plan are the responsibility of the final MFG site. We can then give input for this document.
Validation: production at the final manufacturing site = according to specifications and consistent?
Step 1: Technical Validation
The final MFG site produces the required validation lots according to the regulatory- and safety requirements. Assay-specific protocols are written to test the various assay specifications (for example: Sample type, Accuracy, Total Precision, Cross-Reactivity, Interference, Sensitivity, Specificity, Correlation, Recovery, Linearity, Lot-to-Lot Variation). These protocols are fit to the intended markets (CE [Europe], FDA [USA], Health Canada, CFDA [China], PMDA [Japan]). Our dedicated team verifies that the validation lots comply with the design requirements mentioned in the product specification form. The experimental data are interpreted, the validation report is written and formally reviewed. The outcome of the validation studies can/will be used to support the label claims. Furthermore, these results are used as performance characteristics in the Instruction For Use (IFU).
Step 2: Stability Studies
We set-up the stability studies for your product with multiple validation lots as described in a Stability Plan. The topics include, but are not limited to: real-time, accelerated, MFG in process, shipping and in use (on-board) stability. The designed stability studies will meet the stability requirements stated in the design input and are compliant with NEN-EN-ISO 23640. As real-time stability studies run for prolonged periods, we will produce an interim stability report with results to date. This report will be updated upon availability of new stability time points.
Step 3: Clinical Validation
During the clinical validation, evidence is generated that your assay yields satisfactory results when performed in an end-user environment. To this end, routine clinical samples are used, including samples with extreme values. Your preferred external clinical trial sites will be used or we can help you find the right sites for the clinical validation. In general, management of the clinical validation is done by the customer or an external party. The owner of the clinical validation writes a report with the clinical validation study results.
Why involve us in your V&V work:
- Get your IVD product CE/FDA ready in time
- Minimal involvement required from your R&D and QA teams
- Work with our dedicated, highly experienced teams
- Confidentiality is guaranteed
- Compliant with NEN-EN 13612 and CLSI guidelines
- If desired transferable to our manufacturing
- Free up your own R&D team to initiate new developments
How we can assist you:
- Write and approve all validation protocols, according to regulatory (CLSI) guidelines
- Perform testing and analyze obtained data
- Write up validation reports
- Completion of the design history file
- Collecting necessary validation samples