Electronic Laboratory Notebooks (ELNs) have existed commonly in the bioanalytical industry for several years, but few companies deploy a validated, fully-integrated ELN that easily accommodates both regulated and non-regulated work. These fully integrated ELNs are a result of CROs rethinking automation to encompass the entire workflow, from laboratory processes to QA review. This is ultimately the way biopharma will fully realize higher quality data with efficient, faster turnaround.

To be sure, we in the bioanalytical services industry have spent untold millions on autosamplers, robotic liquid handlers and a multitude of other laboratory automation systems in the name of increasing upstream efficiency. But while we’ve managed to successfully remove data choke points from the lab, in many cases we’ve only shifted them downstream.

Quality control (QC), quality assurance (QA) and reporting are prime examples of constriction points. An analyst who weighs out a reference standard on an uncalibrated balance may be committing what seems to be only a minor error. However, in a paper-based laboratory where QA/QC review is done after the studies are completed, that mis-measured reagent will subsequently affect vast amounts of other data. QC will catch the error some days later, with the full impact of the deviation slowly unfolding as the mass of potentially tainted data is manually audited and exposed. Thus, despite upstream efficiencies, work slows down, and the sponsor still suffers a delay.
 
So, how does the electronic lab notebook minimize constriction points and downstream effects? The answer: look past the “electronic sticker book” functions of an ELN and comprehensively integrate the entire lab into the system.
 
For instance, let’s return to our rhetorical analyst. Before weighing a reagent, he or she would review data about the balance, including its last calibration via a barcode. If the standard operating procedure requires the analyst to calibrate the balance before use, the ELN can be programmed to prevent any measurements prior to it being calibrated on a given day. The beauty here, clearly, is that we can prevent errors before they happen.
 
As long as an ELN is designed and implemented properly, a fully integrated ELN will improve a lab’s transparency and traceability. Care needs to be taken to ensure that the implementation meets the expectations of regulatory reviewers.
 
At the 11^th Annual Applied Pharmaceutical Analysis Meeting in Cambridge, MA in September, John Kadavil, Ph.D., of the U.S. Food and Drug Administration’s (FDA) Office of Study Integrity and Surveillance, gave a well-received talk in which he spoke on the adoption of Electronic Laboratory Notebook (ELN) for use in regulated bioanalytical studies. Though many scientists at CRO and pharmaceutical companies have expressed concern about the FDA’s perception of use of ELNs, Kadavil indicated that the agency is seeing an increase in the use of ELN’s during their audits. The real question: whether ELNs are being used to their fullest extent for improving quality reducing lab errors while meeting the expectations of regulatory reviewers.
 
When each piece of data automatically comes with a time stamp and a name attached and the need for translating handwritten notes is gone, studies are much easier and faster to audit. QA review can be shortened to a few days, versus the industry standard of several weeks. Studies can even be audited remotely by internal staff and external auditors via secure network connections. During a recent directed and general surveillance inspection conducted by the FDA, for example, the efficiency and ease of auditing via our ELN allowed the inspectors to access data quickly. The ELN system enabled questions to be answered and resolved promptly.
 
To recap, using ELNs can help reduce the number of QA/QC issues found downstream after the conduct of laboratory studies. Along with this benefit, data can be stored electronically and quality audits can be performed on a larger portion of data in shorter timeframes. The transition to such a system may take some getting used to and require considerable upfront time & resources, but we’ve found auditing via an integrated ELN is much faster and more efficient than traditional paper audits.
 
This dynamic change in workflow is readily available using off-the-shelf ELN software. However, going beyond the ‘sticker book’ functionality of an ELN requires innovative rethinking on how best to use it.
 
ELNs can fully integrate the entire lab workflow, serving as a foundation to prevent common laboratory and documentation errors for regulated studies. The ELN can be modified to document non-regulated assay research and development, acting as a repository of information for efficient tech transfer between scientists. Timelines and bottom lines are greatly improved.
 
Bioanalytical science has a great tradition of using automation to accelerate data output. There is no reason to ignore the opportunities to extend that automation to areas such as QA, QC and reporting. Fortunately, the technology is readily available and merely awaits thoughtful deployment.
 

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Bo Kowalcyk has 18 years of CRO industry experience supporting FDA regulated studies, including 10 years in the laboratory as a medicinal & GMP process chemist. Since joining AIT Bioscience, Bo has been part of several client-centered training seminars on their ELN and conducted many web-based live demos to showcase the utility of their ELN to clients.