Validation involves performing laboratory tests to verify that a particular instrument, software program, or measurement technique is working properly.

Confidence in forensic DNA results is gained through validation studies, which provide objective evidence that a DNA testing method is robust, reliable and reproducible. 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.

Click the link below to read more about the validation process.
Validation: What Is It, Why Does It Matter, and How Should It Be Done?
By John M. Butler, National Institute of Standards and Technology

There are a variety of challenges a forensic DNA laboratory faces when implementing a new methodology. A common challenge identified by laboratories is a lack of resources available to perform validation experiments. Laboratories also point to the existence of diverse opinions with respect to validation protocols, sample numbers and definition of appropriate and effective experiments as notable challenges. These variables have been shown to contribute to extensive validation studies that include unnecessary or excessive tests without the benefit of additional confidence. In addition, data management and analysis are cumbersome processes that are often manual operations or utilize a series of tools which analysts have developed on their own.

Click the link below to learn more about the challenges laboratories face while implementing new technololgies.
Forensic Magazine: Issue April/May, 2007
The Evolution of Forensic DNA Laboratories and The Challenges They Face
By Dennis J. Reeder, Lisa Lane Schade, and Lisa Calandro


Validation Resources

The Validation and Verification Atlas CD organizes information on forensic DNA analysis methods and provides direct access to Applied Biosystems developmental validation studies, reference materials, quality assurance and control activities guidelines, user bulletins, user manuals, and other supporting documentation. It is an extension of the validation support tools available from Applied Biosystems and our commitment to continue working with the forensic community to help scientists meet vital quality assurance and control activities guidelines.