Qiagen, 9245629, HID Validation Services

Comprehensive customized validation service for forensic or HID testing

Features

- Supports the validation process of new methods
- Supports the validation process of new instruments
- Aims to cut validation time by up to 50%
- Individualized approach ensures customer satisfaction

Product Details

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.

Performance

- 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)

All our validation studies meet or exceed the requirements of these standards:

Principle

- Validation planning
- Execute validation
- Data analysis and report writing
- Validation report
- Validation teach-back

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:

Procedure

Validation service*: Extraction
Consultative validation planning: Yes
Scope of work agreement: Yes
Comprehensive validation plan: Yes
Onsite support to execute validation: Yes
Comprehensive data analysis: Yes
Validation report: Yes
Validation teach-back: Yes

Validation service: Extraction
Sensitivity study: Yes
Reproducibility study: Yes
Precision study: Yes
Contamination evaluation: Yes
Mixture study: Yes
Stutter assessment: Yes
Concordance study (NIST**): Yes
Known and non-probative sample study: Yes
Analytical threshold: Yes
Stochastic evaluation: Yes

Inclusive services

* Actual studies subject to local regulations and customer requirements.

Configurable services

** Dependent on availability.

Applications

You get a workflow to suit the needs of your laboratory. Our highly qualified Application Specialists are experts from the forensic field, each with multiple years’ experience through senior roles in forensic DNA analysis. They combine molecular biology expertise with extensive technical experience, and understand your systems and their possible applications.