Final ProgramCPSA 2011
Science and Technology Coming Together to Make a Difference
October 3 - 6, 2011
Bucks County Sheraton Hotel
Langhorne, PA
Poster Abstract #33
Application of a Novel Bench-top Orbitrap Mass Spectrometer with a Quadrupole Mass Filter for Metabolite Profiling in Drug Discovery
AIT Bioscience, 7840 Innovation Drive, Indianapolis, IN 46278, USA
Use of electronic laboratory notebooks (ELNs) for regulated bioanalysis requires validation of numerous ELN workflows. Presented here is a strategy for using common ELN functionality to validate workflows such that subsequent reviews are more efficient and comprehensive than for typical software validation. It involves execution of scripts similar to those employed during typical software validation, but with a twist. Traditionally, successful execution of scripts is affirmed by signing and dating a brief note stating that the expected results were observed. An ELN, however, can provide advantages when the electronic results of each script execution are saved as a unique, retrievable version of an ELN experiment. This way, during review of the workflow validation, the result of each and every executed script is available for scrutiny exactly as it appeared during testing.
An ELN test plan is written to include instructional scripts to be executed during validation. The test plan and the workflow being validated are executed simultaneously in separate ELN experiments. Script-designated functions are described in the test plan experiment, and performed in the workflow experiment, which is then version-saved, rendering it forever retrievable. For each individual script in the test plan experiment, the saved version of the corresponding workflow experiment is documented, along with any comments.
Testing a specific ELN workflow in this manner results in a complete electronic validation "package", including supporting experiments, that is accessible for review by Quality Assurance and approval by Management. This review process is efficient, yet comprehensive, as every executed script result is a click away, and yields exactly what the tester observed during validation, as opposed to a traditional "Observed expected results" comment that cannot be confirmed during review. The entire resulting electronic validation "package" corresponding to each validated workflow can be conveniently archived for future reference and review.
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