Although every validation is different, the advice and experiences of others can help you develop your own validation plan.
The automation platform has been chosen, the crate delivered, the liquid handler is installed, users have been trained, and methods have been created. A lot has already been accomplished but, what’s next? It’s time for validation!
On the surface it seems that developing and executing a validation plan should be a fairly straightforward process. Liquid handlers are large pipetters, therefore much of their validation is involved in ensuring that they pipette accurately. Some automated protocols, such as extractions, require additional hardware like shakers and heaters which quickly moves the validation project from verification of pipetting to validation of entire methods and steps in the forensic DNA workflow. Many labs also include a comparison of manual and automated techniques to ensure that the automated results are comparable or better than manual processing.What originally seemed to be a simple process quickly begins to increase in complexity. It’s important to remember that validation is a balancing act, trying to ensure the process works well without delaying implementation of new techniques with exhaustive experiments.
While every laboratory is going to approach validation in a different way and with different goals there are always commonalities. One of the best ways to brainstorm ideas for developing a validation plan is to talk with other laboratories that have already validated automated methods. It’s possible to learn from both their successes and the difficulties that they encountered during validation. The remainder of this article shares perspectives from three different laboratories to help get you started.
New York State Police Forensic Investigation Center
The DNA Casework section is currently comprised of nearly 40 DNA Forensic Scientists performing STR analysis and over a dozen Senior Laboratory Technicians performing DNA extraction through amplification. The implementation of a high-throughput core has proven to be very advantageous. The ability to generate high quality data for a large number of cases while simultaneously reducing both the flow time and amount of user involvement has been pivotal for the New York State Police.
The Forensic Investigation Center’s first automated workstations, the Biomek 2000s were acquired in 2001 when the capacities and roles of these platforms in day-to-day casework operations were just being realized. In 2006, the DNA Casework section went online with a validated and fully integrated high-throughput facility. The facility had successfully streamlined and automated the operations of DNA extraction, RT-QPCR analysis, normalization and STR PCR amplification setup, and multi-capillary genetic analysis. The steps were also seamlessly interconnected via a concurrent validation of a barcode tracking Laboratory Information Management System (LIMS).