By Harley Everett Wilcox, MBA
Senior Scientific Advisor
I started my career in the pharmaceutical industry in the
early 1980’s and recall how we documented experiments in laboratory notebooks.
As part of the synthesis research group, most experiments were synthesis of new
molecules or purification of existing compounds. Almost every data entry or
summary was manual and certain data were creatively documented. For example
thin layer chromatography would be described by one of three techniques, a
table listing retentions based on distance, a hand drawing showing relative
spot size and location on the plates, or a photocopy once color copiers were
available. NMR spectra existed most as a hard copy. Early notebooks were a
single copy where a user copy was provided back to the user copy once the
notebook was completed. Advances in notebook technology included two sheets for
experiments and several sheets of carbon paper for an immediate copy. For higher compliance such analytical
efforts, an exhibit books containing plots and chromatographic printouts
accompanied the actual notebook. Peer review signatures and some QA review were
incorporated. Eventually electronic scanning allowed for the first electronic
storage.
Will the introduction of robots interfaced with electronic data systems eliminate the need for a warm bodied chemist for certain types of analysis?
Today, technology and compliance have significantly evolved.
I spent a few moments with our LIMs
administrator, Kevin Cornel, for a Q&A on electronic laboratory notebooks
(ELN), and although ELN’s have been available for some time, I was surprised to
the extent the systems can help eliminate human errors and support automation.
With the introduction of laboratory information systems, instrument
software, and electronic notebooks it would appear that the future may hold
data generation with limited human input.
Users have electronic workbooks where menu’s for reagents, methods etc.
are chosen and the entire experiment can use electronic inputs from balances,
pH meters and HPLC’s interfaces etc. Bar
codes are scanned for samples, reference standards, and reagents to almost
eliminate opportunities for errors and flag non-compliance such as expired
reagents. Bar coding glass pipets, glassware are possibilities may serve to
further refine experiment as well as provide more explicit data records.
Electronic signature and permanent electronic profiles of all activities for a
study allow for efficient auditing.
Clearly ELN’s will improve efficiency and quality but the
information system requires significant up front resources. Existing software
platforms must be compatible with ELN systems or interfaces will need to be
created. Information services will create methods, workbook formats and all
other desired fields and complete validations. Analyst will require training for the chosen
software systems for system set-up and management. Opportunities for errors
then reside almost exclusively with the initial sample inventory and sample
management where a sample/compound arrives and sample data is entered into the
information system via barcode or like. A second reviewer of the upfront data
entries may be worthwhile.
Will the introduction of robots interfaced with electronic data systems eliminate the need for a warm bodied chemist for certain types of analysis?
