Integrate, validate & implement. Human Identification Professional Services

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1 Integrate, validate & implement Human Identification Professional Services

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3 As a world leader in human identification, we continue to develop and deliver technologies, services, and solutions to meet the evolving needs of the global forensics community. Our comprehensive offerings include instruments, software, kits, reagents, and consumables, as well as teams of dedicated field service, field application, and global training professionals to support them. At the core of our offerings are services designed to help labs integrate, validate, and implement new methodologies and technologies. 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. 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 if you re looking for a regional or countrywide complete turnkey solution, our expert HPS team can work with you in achieving your goals. 1

4 Rely on our team of experts Our HPS team is comprised of experts in forensics, DNA analysis and interpretation, robotics and laboratory information management systems (LIMS) integration, project management, and a variety of other disciplines required to address the current and future needs of forensic laboratories globally. Whether you re in a casework or reference/database laboratory, the HPS team is here to help you with the adoption of new technologies, as well as the integration of existing technologies in an increasingly complex laboratory environment. 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 Contact your local sales representative for more information. 2

5 Validation and performance checks are critical and time-consuming processes that are part of adopting new methodologies and technologies. Our globally deployed validation team has experience in these areas. The final reports that are delivered are in compliance with all recommended international guidelines including ISO17025, SWGDAM, NATA, UKAS, KOLAS, NABL, ASCLD/LAB, and ISO/IEC. Validation It s up to the lab to accumulate test data and demonstrate that the methods and procedures perform as expected. This validation, which is sometimes referred to as internal validation or method development, is needed whether the methodology being adopted is an instrument, software, human identification kit (DNA extraction, quantification, or STR analysis), robot, or another piece of equipment that s part of a workflow. The validation establishes the scientific parameters for optimal performance and sets the framework for the lab to develop its SOPs, staff competency testing, and interpretation thresholds. 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. 3

6 Choose from flexible solutions The HPS team offers an array of services to meet your needs, including: Robotic systems and LIMS integration/validation Lab relocation Lab renovation Project management Accreditation support SOP development Operational efficiency programs Advanced HID training 4

7 Service* STR casework STR database Quantification Extraction Validation Performance check Validation Validation Performance check Validation Consultation with client to determine needs 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 nonprobative sample study Stutter assessment Thorough data analysis Validation report binder(s) and CD(s) Teachback lecture/laboratory practical Support with development of optimal interpretation guidelines, SOPs, and audits *The actual studies performed are subject to change as global regulations or customer requirements change. **Dependent upon NIST standard availability. 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. 5

8 Prepare for the future I was extremely pleased with how the validation, training, and teachback were conducted. The process was well organized and pertinent to our needs. This validation has saved us considerable analysis time, yet we still have as much understanding of the data as if we had done the work ourselves. Technical leader, county crime lab, US Robotics selection and implementation Labs worldwide are increasing the throughput of samples through their casework and database workflows, which is increasing the desire for robotic implementations. However, many labs, especially new ones, often find it difficult to identify the right robotic system(s) to use and to effectively validate, integrate, and implement the system(s). Our HPS team has extensive expertise in designing and implementing robotic systems from a variety of vendors. 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. Reporting At the conclusion of a project, you will receive a comprehensive validation report (in both print and electronic formats) that has been technically reviewed by forensic experts. This report will serve as the scientific foundation on which your laboratory will begin implementing the technology. Training and support With the adoption and/or integration of any new technology, it is critical that all users in the lab are thoroughly trained on the instruments, kits, software, and workflows. To address this need, we offer an array of specialized training programs, and our forensically trained specialists and field service engineers are available to assist you. 6

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11 Get support wherever you are Our HPS team has developed and executed more than 300 validation and/or integration projects in 16 countries worldwide. The team is available to work with customers nearly everywhere around the world. Global project sites: United States Canada England Scotland Germany Poland South Africa Namibia Singapore Malaysia Thailand Australia UAE Libya India Japan Contact your local sales representative for more information. 9

12 Hear it from your peers We routinely survey customers following the completion of projects to help us continually improve our offerings and to identify additional capabilities needed to address unmet needs. 98% More than 98% of surveyed customers said they would recommend the HPS team to a colleague. Over 35% of customers have used the services of the HPS team more than once. The validation was well worth the cost. I would have it no other way. The presentation you receive after your validation is unbelievable. Great! It s already in the format for auditing. Technical leader, state crime lab, US For Research, Forensic, or Paternity Use Only. Not for use in diagnostic procedures Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. 10 CO