omation mbers - Society for Laboratory Automation and Screening

TP050
Lynn Hilt
The Ashvins Group, Inc.
Bio IT Professionals
8390 N W 53rd Street, Suite 200
Miami, Florida 33166
jberlin@ashvinsgroup.com
Software Validation for Automation Projects
171
Co-Author(s)
Terry Weeks
Thoroughly characterized and dependable software is a critical component of laboratory automation projects. The
use of software to automate and streamline laboratory operations include projects that 1) automate laboratory
procedures with robotic systems; 2) consolidate data collection and analysis; 3) manage and share data collected
from sophisticated drug discovery or clinical research processes and/or 4) interface instruments, systems and
software. Often these projects involve custom applications or modifications of Off-the-Shelf (OTS) software
products. It is clear that these systems must satisfy Good Laboratory Practices (GLP) requirements, but the
scope and methods employed to validate computer related systems is highly subjective.Validation of computer
related systems is often complex, and alternate approaches may be used. The appropriate validation effort will
depend upon various factors, including the complexity of the system, intended use of the system, and whether the
functions are critical or non-critical in the automation project. This poster identifies factors to be considered and
steps to be taken in validation of Computer Related Systems used in GLP environments.Validation technology may
be addressed through a variety of testing formats such as:
• Installation and Operational Qualification (IQ/OQ)
• Off-the-Shelf Software (OTS) Validation
• Custom Software Validation and Verification (V&V)
In conclusion, pertinent validation testing and documentation are required to demonstrate proper performance of
Computer Related Systems used to support laboratory automation projects.
TP051
Randall Hoffman
Invitrogen Corporation
Screening Applications
501 Charmany Drive
Madison, Wisconsin 53719
randy.hoffman@invitrogen.com
Co-Author(s)
Gerald Habenbacher, Tecan Austria
Ion Channel Assay Development Using Voltage Sensor Probes on the GENios Pro
Multifunctional Reader From Tecan
Ion channels are important drug targets because of their critical role in nerve, cardiac, endocrine, and skeletal
muscle tissues. The lack of sufficiently sensitive, high throughput screening systems has hampered research
in this area. Voltage Sensor Probes (VSP) technology can be used with any ion channel target that changes
membrane potential, and is therefore well suited for sodium, potassium, calcium, chloride, and ligand-gated ion
channel research. The FRET-based detection method provides ratiometric results which significantly reduces errors
arising from well-to-well variations in cell number, dye loading and signal intensities, plate inconsistencies, and
temperature fluctuations. These combined features make VSP technology highly amenable for high throughput
screening (HTS) applications. Assay development and therapeutic groups develop and validate ion channel assays
prior to HTS and may have lower throughput instrumentation that may or may not be amenable to VSP technology.
This abstract demonstrates the use of Tecan’s GENios Pro instrument as a suitable platform for development of
VSP ion channel assays in both the pharmaceutical and academic environments.
POSTER ABSTRACTS