Description
Validation of new equipment or methods is an important part of any forensic quality assurance system. When a new technique is introduced, an internal validation study must always be conducted to demonstrate that the procedure is robust, reliable and reproducible, that it ensures personnel safety, and adheres to all local and national regulatory standards. QIAGEN offers a consultative Validation Service to human identity (HID) and forensic laboratories supporting the validation process of new technology and application implementation. Our comprehensive service offers complete internal validation of your purification systems, assays and automated workflows in forensic or HID testing. Want to discuss your laboratory validation requirements with one of our specialists? Please select Inquire to learn more about Customized Validation Planning.
All our validation studies meet or exceed the requirements of these standards: ISO/IEC 17025:2005 ENFSI Recommended Minimum Criteria for the Validation of Various Aspects of the DNA Profiling Process (2010) FBI Quality Assurance Standards for Forensic DNA Testing Laboratories (2020)
Customized Validation Planning QIAGEN offers an individualized approach to every validation ensuring complete customer satisfaction. Working with each laboratory, a defined scope of work will be agreed choosing from these options: Validation planning Execute validation Data analysis and report writing Validation report Validation teach-back
Inclusive services Validation service* Extraction Quantification STR amplification: Casework STR amplification: Database Consultative validation planning Yes Yes Yes Yes Scope of work agreement Yes Yes Yes Yes Comprehensive validation plan Yes Yes Yes Yes Onsite support to execute validation Yes Yes Yes Yes Comprehensive data analysis Yes Yes Yes Yes Validation report Yes Yes Yes Yes Validation teach-back Yes Yes Yes Yes * Actual studies subject to local regulations and customer requirements. Configurable services Validation service Extraction Quantification STR amplification: Casework STR amplification: Database Sensitivity study Yes Yes Yes Yes Reproducibility study Yes Yes Yes Yes Precision study Yes Yes Yes Contamination evaluation Yes Yes Yes Yes Mixture study Yes Yes Yes Stutter assessment Yes Yes Concordance study (NIST**) Yes Yes Yes Known and non-probative sample study Yes Yes Yes Yes Analytical threshold Yes Yes Stochastic evaluation Yes Yes ** Dependent on availability.
