Validation Services to Support Collaborative Forensic DNA Analysis Worldwide

Jonelle Thompson, Promega Corp., Madison WI, USA

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Introduction

Forensic DNA laboratories face increasing challenges as new technologies emerge and regulatory requirements evolve. These developments have increased the demand for validations, with many laboratories turning to trusted partners for guidance in navigating this process. At Promega, our Global Validation Services team simplifies and streamlines validations by providing guidance and hands-on support for new chemistries and instruments. We work closely with laboratory staff to ensure understanding of the systems. This collaborative approach delivers tailored strategies aligned with each lab’s workflows, goals, and budget.

Expertise and Consistency Across Regions

Promega’s validation scientists have performed internal validations on a wide array of products at different laboratories, including:

  • Maxwell® RSC 48 Instrument
  • Casework Direct System
  • Bone DNA Extraction Kit
  • PowerQuant® System
  • PowerPlex® STR Systems
  • Both Spectrum and Spectrum Compact CE Systems
  • Maxprep® Liquid Handler

Additionally, the Validation Services team has been heavily involved in performing developmental validations for products such as PowerPlex® 35GY System, Maxwell® RSC Instrument, Spectrum Compact System, Spectrum CE System, and PowerQuant® on QuantStudio™ 5 Real-time PCR System for Human Identification. These validations ensure that laboratories adopting these technologies can do so with confidence in their reliability and performance.

One of the strengths of our Global Validation Services team lies in the depth and diversity of our expertise. Collectively, the team has more than a century of experience, with backgrounds as technical leaders, quality assurance managers, auditors, researchers, and validation managers in forensic laboratories. This extensive experience allows us to address the unique needs of each laboratory with precision and insight.

Benefits of Outsourcing Validation Services

Using vendor-based validation services can provide a wide range of benefits. Having a full-time person devoted to the process who is highly experienced with the product and validation process can significantly save time. Outsourcing validation projects saves significant staff hours, allowing in-house scientists to focus on critical tasks like casework, training, or improving internal processes. By leveraging outsourcing options, labs can streamline processes, maximize resources, and achieve reliable, high-quality outcomes, often in a shorter time period than if the laboratory took on the validation itself.

Outsourcing can take various forms, with the level of involvement tailored to the laboratory’s specific needs.

  • Full Validation: The Promega Validation Services team manages all aspects of the validation process, including laboratory work, data analysis, and report writing.
  • Remote Validation: The laboratory conducts the hands-on work, while the Promega team handles data analysis and report writing.
  • Custom Options: Flexible solutions designed to support specific aspects of the validation process based on the lab’s requirements.

Technical Details of Validation Process

Our validation process involves several key steps to ensure thorough and reliable results:

  • Initial Assessment: We begin with an initial assessment of the laboratory’s current systems and workflows. This helps us understand the specific needs of the laboratory.
  • Statement of Work Development: Based on the assessment, we develop a detailed validation plan tailored to the laboratory’s requirements. These plans outline the studies and calculations that will be performed for validating new chemistries and instruments.
  • Hands-On Support: Our team provides hands-on support during the validation process by performing the laboratory bench work and working closely with laboratory staff to ensure proper understanding of the workflow.
  • Data Analysis: We perform comprehensive data analysis to evaluate the performance of the validated systems.
  • Report Generation: Finally, we generate detailed validation reports that document the entire process, including the methods used, results obtained, and conclusions.

Building Confidence Through Validation

At the end of the day, validation is about more than meeting accreditation standards, it’s about cultivating trust. When forensic DNA evidence is presented in court, jurors, judges, and the broader public need to know that the data is accurate, reliable, and robust. Laboratories that invest in thorough validation efforts aren’t just “checking a box”; they are building the foundation for protocols.

Our Global Validation Services team’s role is to make this journey as straightforward as possible. Whether you’re a laboratory looking to implement a new technique, a manager seeking to optimize existing workflows, or simply curious about what goes into a validation, we’re here to help.

Leveraging Dedicated Resources

To further support forensic laboratories, Promega offers a wide range of free, accessible tools and information. These include validation guides, technical manuals, and webinars — many of which are featured on our Validation Resources page:

Validation Resources
Other Resources

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