omation mbers - Society for Laboratory Automation and Screening
omation mbers - Society for Laboratory Automation and Screening
omation mbers - Society for Laboratory Automation and Screening
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WP070<br />
Melissa Trout<br />
Code Refinery<br />
2201 C<strong>and</strong>un Drive, Suite 101<br />
Apex, North Carolina 27523<br />
mtrout@code-refinery.com<br />
Integrating Software Validation Throughout Software Development<br />
226<br />
Co-Author(s)<br />
Samir D<strong>and</strong>ekar<br />
Mike Brown<br />
Code Refinery’s software validation methodology allows a customized approach <strong>for</strong> all phases of the software<br />
development life cycle. Closely integrating validation into the development life cycle improves software quality<br />
<strong>and</strong> reduces cost <strong>and</strong> ef<strong>for</strong>t when attempting to obtain product approval from regulatory agencies. Code<br />
Refinery’s focus relies heavily on three st<strong>and</strong>ard concepts: communication, documentation <strong>and</strong> testing. Efficient<br />
communication among team me<strong>mbers</strong> is vital during the review of validated documents, goals <strong>and</strong> project plans.<br />
To accurately include validation in a software product’s development, documentation must verify that each step in<br />
the development life cycle fulfills the requirements of the previous stage in order to meet the needs of the ultimate<br />
end user. Lastly, comprehensive testing verifies that the software consistently meets user needs, fulfills safety<br />
regulations <strong>and</strong> operates without defects in critical functionality. Code Refinery’s integrated validation will control<br />
<strong>and</strong> minimize the variables impacting software development. The software validation methods <strong>and</strong> documents<br />
outlined in this poster illustrate the effectiveness of structured, supportive software validation.<br />
WP071<br />
Robert Umek<br />
Meso Scale Discovery<br />
9238 Gaither Road<br />
Gaithersburg, Maryl<strong>and</strong> 20877<br />
rumek@meso-scale.com<br />
High Throughput Multiplexed Assays <strong>for</strong> Biomarkers <strong>and</strong> Phosphoproteins<br />
Co-Author(s)<br />
Paula Denney Eason<br />
Jenny Ly<br />
Jacob N. Wohlstadter<br />
The intense interest in biomarkers <strong>and</strong> phosphoproteins arises from their importance in critical processes. These<br />
proteins are best measured in a multiplex <strong>for</strong>mat: underst<strong>and</strong>ing a given signal transduction pathway often requires<br />
measuring multiple phosphoproteins <strong>and</strong> samples containing biomarkers (e.g., serum) are often precious. In this<br />
poster we present multiplex immunoassays <strong>for</strong> biomarkers <strong>and</strong> phosphoproteins using Meso Scale Discovery’s<br />
(MSD’s) Multi-Array plat<strong>for</strong>m. These assays are conducted in MSD’s Multi-Spot plates, using plates pre-coated<br />
with capture antibodies <strong>for</strong> each biomarker or phosphoprotein, a cocktail of labeled detection antibodies <strong>and</strong> other<br />
related assay reagents. The assays offer excellent sensitivity, compatibility with complex samples such as serum or<br />
blood, <strong>and</strong> a wide dynamic range that avoids the necessity of multiple dilutions.
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