| Summary: | ABSTRACT
Barry J Harnick
RIGHT-SIZED RISK-BASED DEPLOYMENT OF A COTS CHROMATOGRAPHY
DATA SYSTEM
As technology advances, computer software has taken a large position in the modern
laboratory. The exponential growth of data produced in biopharmaceutical laboratories
today has forced the need for moving from capturing data on paper or storing it in
spreadsheets and small, non-robust databases to the need for having an automated and
secure data management platform. In the November edition of the 2003 Scientific
Computing & Instrumentation LIMS Guide, M. Elliott (2003) pointed out that
traditionally laboratories have looked to Laboratory Information Management Systems
(LIMS) to assist in managing the ever increasing information workload. In the not so
distant past, these LIMS and other systems were custom systems that largely delivered
every user requirement, specific to each company’s internal processes. However, new
regulations and reporting requirements have stretched this model and the reality of longterm
maintenance costs have brought about the integration of systems within laboratories,
not only to collect data but also manage these systems in a way that insures long-term
preservation and knowledge retention. This integration is not without its challenges,
especially when it occurs in a heavily regulated industry such as pharmaceuticals. While
there are certainly technical challenges associated with this integration, this strict
regulatory environment particularly requires expensive, tedious validation of most
software. Into the software validation mine field has entered the risk-based verbiage
recently espoused by the United States Food and Drug Administration (FDA). This
verbiage might either be the bane or panacea for an industry that is trying hard to focus
on making the next block-buster drug, not on developing internal software.
So, how does a large pharmaceutical company meet tightening FDA guidelines and
accomplish their true drug discovery goal? The solution might be in another type of
integration- namely integrating laboratory processes, risk-based software validation, and
a Commercial-off-the-shelf (COTS) system. The resulting blend will nearly certainly
hold more initial deployment pain for the laboratory, as the COTS system cannot be
modified to completely fit the current laboratory processes. Often, however, the
validation and compliance benefits might greatly outweigh the initial costs.
The thesis project consisted of developing a right-sized, risk-based validation
package for a COTS chromatography data system (CDS) and the subsequent deployment
of the validated software. Validation included first developing a detailed risk assessment
to guide right-sizing the validation effort, taking current regulatory guidance on riskbased
software validation into account. This is the approach of a large pharmaceutical
company that is seeking to minimize direct involvement in software development, while
minimizing the significant risks that come from software, whether developed internally or
by an outside vendor. This project explored the various ways risk-based validation and
COTS software vendor management can reduce validation, deployment and maintenance
costs, especially those associated with the testing and on-going maintenance of a COTS
package.
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