The data managers and biostatisticians of the
Biotechnology company had a huge backlog of clinical trial laboratory results
that needed to be validated before analyses could be completed for the trials.
The consultant met with the data managers and biostatisticians to identify the
types of errors they were seeing and to determine what types of errors were
occurring and what types of error checks could be automated.
A requirements document was produced and the consultant
initiated a project for the company that produced a system that processed lab
results, flagged the records with errors, and returned the problem records to
the central laboratories for correction. The project provided all of the
documents necessary to satisfy system validation for the FDA. The system
reduced the turn-around time for lab data validation from months to hours.
Error analysis automated
FDA requirements satisfied
Turn-around time for lab data validation reduced from
months to hours
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