Bioanalytical contract research organizations (CROs) have been adopting electronic lab notebooks (ELNs) for several years now, but few ELN labs deploy a validated, fully-integrated platform. As we recently wrote for Contract Pharma, the jump from an electronic sticker book to a truly paperless workflow can revolutionize a lab’s efficiency and prevent errors before they happen.
At its core, electronic lab notebook software stores and manages laboratory information. A lab manager can purchase an out-of-the-box system for basic needs such as data collection (see The Scientist’s great roundup of options from 2010). But if you’re willing to invest in some IT, you can customize an ELN to manage all the finer details of your lab’s workflow, such as incorporating your standard operating procedures and automating quality audits. Our system even tracks how often our instruments are calibrated and prevents an analyst from collecting data unless they follow the SOP.
Fully-customized and integrated ELN software serves to:
- Prevent errors before they happen
- Generate higher quality data with faster turnaround
- Eliminate bottlenecks in QA/QC and reporting
- Create a truly paperless lab (not just less paper)
Case in point: The FDA recently visited AIT Bioscience to perform a directed audit of our lab in order to verify the data quality of a sponsor’s study under their review. A typical inspection could have meant a week of gathering paper records and combing through hand-written notes, comparing them to SOPs and regulatory policies. Instead, the FDA finished their audit in a few days because they could access all the data they needed electronically via hyperlinks to SOPs, training records, metrology records, assay data, reports, etc. This included the time of the data point, the name of the scientist who collected it and the procedure they followed.
Biopharma will see their timelines shrink and their bottom lines grow as more of their partners rethink ELNs to encompass their entire workflow. These benefits do not depend on some future technology, but rather on CROs taking full advantage of the tools already available to them.
Want to streamline your lab workflows? Contact us to get started.