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Integrate, validate, and implement

Since 2007, our Human Identification Professional Services (HPS) team has been helping customers like you successfully navigate the validation process required to bring new technologies into operation. At the core of our offerings are services designed to help forensic DNA labs integrate, validate, and implement new methodologies and technologies.

We are ready to help you validate next-generation Life Technologies™ solutions such as Quantifiler® HP and Trio*, GlobalFiler®**, and YFiler® Plus** kits on supported instruments and robotics systems.

Frequently asked questions Contact us


Choose from flexible solutions

The HPS team offers an array of services to meet your needs, including:

  • Validation and performance checks
  • Accreditation support
  • SOP development
  • Consultancy and operational efficiency programs
  • Advanced HID training
  • Project management
  • Lab relocation/renovation
  • Robotic script verification/validation
  • LIMS integration/validation
  • Turnkey solutions and bespoke packages

“The rapid deployment of this new, state-of-the-art forensic science services center is allowing us to achieve our goals faster to provide forensic DNA testing in our community. The assistance of Life Technologies application experts was instrumental in speeding up the process and enhancing the quality assurance of validation, so we can start processing DNA evidence.”  Technical Leader
crime lab, US


HPS project scope, definition and execution for a typical STR kit validation
1 Experimental
Design
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2 Perform
Study
Pipette

3 Data Analysis, Report Writing and Scientific Review
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4 Delivery of Validation Report
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5 Teachback Training
Lectern


The right set of solutions for your needs

Through a consultative approach to all services offered, the HPS team can work with you to design and implement the right set of solutions for your needs. Whether the need is for a smaller validation project or consulting engagement, or you’re looking for a regional or nationwide complete turnkey solution, our experienced HPS team can work with you to achieve your goals.

  STR casework STR database Quantification Extraction
Service* Validation Performance check Validation Validation Performance check Validation
Consultation with client to determine needs
Project charter to define scope of project
Detailed experimental plan
Applicable reagents and instrument consumables
Precision study  
Reproducibility study
Minimum threshold      
Contamination
Sensitivity study
Stochastic study        
Mixture study ✓** ✓** ✓**  
Concordance study—NIST  
Known and non-probative sample study    
Stutter assessment    
Thorough data analysis
Validation report binders and cd's
Teachback—lecture/laboratory practical    
Support with development of optimal interpretation guidelines, SOPs, and audits    

The above table reflects the scope of studies to be conducted and may vary depending on customer requirements. For robotic validations and performance checks, the actual studies to be conducted will be discussed and confirmed with the customer prior to starting the project.


Frequently Asked Questions
Why is validation important?
  • Validation demonstrates laboratory procedures to be reliable, reproducible, and robust in the laboratory’s own environment.
    • Reliable—Results obtained by using this method are accurate and correctly reflect the sample being tested.
    • Reproducible—Same or very similar results are obtained each time a sample is tested.
    • Robust—Successful results are obtained a high percentage of the time with few samples that need to be repeated.
  • It is part of the quality regimen of the laboratory or laboratory system.
  • In specific jurisdictions, validation of methods is a regulatory requirement.
  • It defines the limitations of the procedure.
  • The validation of methods is "good science”.
How does the HPS validation service work?

Our HPS team will collaborate with you to customize an experimental design to suit your specific validation needs. We will send experienced Validation Applications Specialists to perform the validation laboratory work in your laboratory, followed by data analysis and report writing performed by our experienced forensic scientists.

Upon completion of the work, we'll deliver the report to your lab and provide full hands-on training, to help ensure your laboratory is equipped with the necessary knowledge and expertise to perform the validated protocol.

The HPS team works with you to minimize your validation efforts and maximize your success in the laboratory.

What is the difference between validation and a performance check?

Validation and performance checks are processes that are part of adopting new methodologies and technologies.

Validation

Validation is confirmation by examination and provision of objective evidence that the particular requirements for a specified intended use are fulfilled.

Validation experiments define procedural limitations, identify critical components of the procedure that require quality control and monitoring, and establish standard operating procedures and interpretation guidelines for laboratories to follow while processing samples.

Performance checks

A performance check is a quality assurance measure to assess the functionality of laboratory instruments, equipment, or software that affect the accuracy and/or validity of forensic sample analysis.

A performance check is a set of experiments conducted on an identical instrument when an existing instrument has been moved or when a material change has been made to an existing instrument. The results of these experiments will provide an assessment of the new, moved, or modified instrument, and correlate it to a validated instrument.

Which international standard is applicable to me?

Our HPS offering aims to enable laboratories to comply with ISO/IEC 17025-2005 standards. The final reports that we deliver are in compliance with all recommended international guidelines, including SWGDAM, NATA, UKAS, KOLAS, and NABL. However, it is your responsibility to perform your own analysis and appropriate internal validation studies to ensure that the products and services you obtain from us satisfy or will satisfy the SWGDAM guidelines or other applicable guidelines used by the forensic community and are fit for its human identification applications.

We also cater to specific quality assurance requirements that may be unique to your region. Please email us through your regional representative listed below to discuss these further.

What will my lab receive as part of the validation package?

Your validation package is fully customizable, depending on your needs and budget.

Experimental design

The HID Professional Services team will adapt to specific requirements and standards of our customers, providing flexibility in designing validation programs.

Reagents, kits, and consumables

Life Technologies™ kits and reagents (even software) that are required for the validation work are included in the package, along with a set of Standard Reference Materials and DNA controls that work to standardize your validation project with others performed elsewhere.

Laboratory work, data analysis, and report writing

HPS will provide the expertise to perform the lab work in your laboratory.

Reports

HPS provides audit-ready documents in multiple media forms (hard copy, disc, electronic).

At the conclusion of a project, you'll receive a comprehensive validation report (in both print and electronic formats) that has been technically reviewed by forensic experts. This report can serve as the scientific foundation on which your laboratory can begin implementing the technology. For an example, please email us through your regional representative listed below to discuss these further.

Extensive hands-on training

Our training program helps ensure laboratory proficiency and troubleshooting capability. It encourages thorough “teachback” and transfer of knowledge to lab personnel, during which knowledge and techniques are tested.

Do you offer training and support?

With the adoption of any new technology, it is critical that all users in the lab be thoroughly trained on the instruments, kits, software, and workflows. To address this need, we offer an array of specialized training programs, and our trained forensic applications specialists and field service engineers are available to assist you. We can customize your validation package to include training as a total solution for your forensic needs.

Do you provide references I can call?

More than 98% of surveyed customers said they would recommend the HPS team to a colleague. We will gladly provide references.

Please email us through your regional representative listed below.

What size project is the HPS team able to help me with?

Whether the need is for a smaller validation project or consulting engagement, or you’re looking for a regional or nationwide complete turnkey solution, our experienced HPS team can work with you to achieve your goals.

Can you help me with my robotics and automation needs?

Yes. Our HPS team has extensive expertise in designing and implementing robotic systems from a variety of vendors. The HPS team has worked with every major robot brand and configuration, and includes dedicated personnel for script-writing and robotic verification projects.

From deck layout and workflow scripting to integrating with new or existing LIMS, the HPS team can partner with you in identifying and implementing the appropriate robotic system for you.

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