Technical project management of your lab’s analytical validation project

Your lab is under constant pressure to stay compliant with standards while expanding the number of molecular tests offered. Validating a workflow is one of the most critical steps prior to launching your new test. Yet, many labs inadequately plan and execute their analytical validation (AV) process. Inefficient AV can potentially turn a 10-week validation into a 40-week process, resulting in substantial delays to the lab’s ability to process valuable samples.

Have a specialist contact me

Introducing the Analytical Validation Consulting service that provides technical project management of your lab’s AV, potentially reducing your overall time to launch by 75%

 

Save Time—Personalized consultation to help accelerate your launch up to 75% faster than the average AV

 

Cut Costs—Helps reduce costs and provides transparency of your end-to-end investment with up to 48% less financial impact than the average AV

 

Maintain Compliance—Proper documentation templates that facilitate your lab compliance, with more than 75 successful engagements



Reduce your assay validation timeline and overall investment

See an overview of the steps of the Analytical Validation process and how our Consulting Service can help reduce your timeline from 40 weeks to 10 weeks.

The AV Consulting Service can reduce your overall investment by up to 48% because of the time savings the service provides. Labs that perform AV themselves pay more in materials and labor, potentially incurring months of loss in revenue opportunity due to delays in sample processing.

Over 75 laboratories have already partnered with us to launch their validated molecular tests.

 

As part of the engagement, our team provides key services throughout the process including:
Project management by a compliance specialist

Dedicated on-site application specialist

Confirmatory sequencing or detection

Workflow optimization
Technical review
Workflow training

What do you get?

Validation plan

Protocol templates
Controls
Data analysis
Final report template

Ordering information

Panel name Cat. No.
Vaginal microbiota, OpenArray format A28966
CFTR (Cystic Fibrosis) gene mutation detection solution, OpenArray format A28279
Pharmacogenomics, OpenArray format AVQS12K
Pharmacogenomics, 384-well format A27145
Genotyping AV Assistance Package*  (tailored package for customers running multiple qualified solutions)

Vaginal microbiota AV Assistance Package* (tailored package for customers running multiple qualified solutions)
A34090
384-to-OpenArray Bridging Study A34089
Custom Genotyping Panel (inquire for custom genotyping requests) A34091
Workflow Training for Genotyping Panels A26745
Workflow Training for Microbial Panels A30162

Contact compliance.sales@thermofisher.com today to find out more about our consulting services.