The traditional practice of recording data in the laboratory revolved around the hand-written transcription of data into a bound, page-numbered, paper laboratory notebook. The management policies involved in the paper laboratory notebook (e.g., check-out, inspections, signed entries, witnessing of data, check-in, and archiving) were tightly followed since the notebooks were used in patent prosecution, intellectual property litigation, and federal agency approvals. However, hand-written transcription is fraught with innocent human error where studies have shown that complete accurate hand-written transcription occurs only 70% of the time (i.e., 30% errors).
In this regard, the electronic laboratory notebook (ELN) has steadily replaced the paper laboratory notebook in modern-day laboratories. The ELN is a computer software program that captures data/metadata without human hand-written error and centralizes the data/metadata in a searchable, exportable, secured, and legally stringent manner. A major advantage for the investigator is that the data can be faithfully exported into a statistical software program for analysis and graphing. Today, ELN software programs exist that capture data/metadata from one or more devices (e.g., densitometer, refractometer, spectrophotometer, titrators, pH meter, weighing balances, melting point device). Laboratory data management tools like Mettler-Toledo’s LabX Software or EasyDirect Software transfer data measured on your instruments to your computer automatically. This optimized data capturing software expands result management capabilities such as csv file exporting, printing on a network or local printer, additional calculations and review of results.
The adoption of the ELN opens new avenues for data/metadata handling such as the use of an even more sophisticated laboratory information management system (LIMS). LIMS is an ever-evolving concept that can be modified and/or updated as the requirements of the laboratory change. However, a LIMS comprises a basic set of five steps which include: 1) log-in of sample (e.g., bar code) and customer data, 2) assignment, scheduling, and tracking of the measurements to be performed on the sample, 3) assessment of the quality control of the sample measurement (i.e., was the measurement performed according to established protocol?) and the utilized device (i.e., was the device properly calibrated?), 4) data storage, and 5) approval (i.e., electronic signature) and compilation of data for reports, statistical analysis, and export to collaborators.
In addition, a LIMS can evolve into a two-way communication pathway whereby information is not only sent from device-to-LIMS but also LIMS-to-device. For example, a LIMS can send the approved standard operating procedure (SOP) for weighing a particular sample to a computer screen next to the balance as the technician is weighing the sample. The technician is then prompted to follow the SOP and any significant deviation from the SOP will be detected and stopped. This type of communication is especially important to laboratories that have strict regulatory compliance concerns like CLIA (Clinical Laboratory Improvement Amendments), HIPPA (Health Insurance Portability and Accountability Act), GLP (Good Laboratory Practices), GMP (Good Manufacturing Practice), and FDA (Food and Drug Administration).
Conversion from hand-written transcription into a bound, page-numbered, paper laboratory notebook to ELN/LIMS produces two distinct advantages. The first advantage is an increase in productivity since the technician spends less time with hand-written transcription and more time running assays. The second advantage is compliance readiness since a laboratory is now audit ready, can easily produce properly formatted audit reports, can establish chain of custody of the data, and can document instrument calibration and maintenance (i.e., quality control).
References:
- Vitz E: Spreadsheet laboratory information management system of general chemistry. J of Chemical Education 69(9):744, 1992.
- Skobelev DO et al: Laboratory information management systems in the work of the analytic laboratory. Measurement Techniques 53(10): 1182, 2011.