Guest post on data integrity - by Natalia Román López, Mettler Toledo
One of the primary motives driving organizations to purchase a laboratory information system (LIMS), electronic lab notebook (ELN), or laboratory execution system (LES) is the appeal of connecting laboratory instruments for electronic data collection. When a laboratory instrument is directly connected, costs in time, labor, and potential error associated with manual data transfer are essentially eliminated. However, even with the compelling advantages, many instruments and systems still remain disassociated with data entry and transfer largely handled manually.
Manual data transcription and report creation keep laboratory users from focusing on his or her science. Frequently, transcribed data lacks certain elements as well as the traceability needed to satisfy internal quality management or regulatory mandates. The end result is loss of time and revenue as time is lost gathering missing data, re-transcribing results, documenting missing controls, and preparing reports. Additionally, laboratory staff must often comply with standard operating procedures (SOPs) for each analysis and document the entire process as well.
More than aggregating results
To the SOP point, while many labs have turned toward LIMS and ELN systems with the idea of replacing the manual workflow, the fact remains that these systems are designed primarily to aggregate data from an array of analytical tests, not to automate and document bench-top workflows or bind instrument metadata with results for traceability purposes. Yet these are the aspects of a truly integrated system that can deliver heightened SOP adherence, easier workflow management and better traceability.
What is needed is a ready-made, configurable solution that drives the workflow SOP directly through the balance or instrument, delivering automatic, integrated instrument management and data capture, allowing to focus on the analysis. The instrument control and workflow support provided by such a system forms an ideal foundation to the IT hierarchy. This layer interacts on a unidirectional or bi-directional basis with the others using standardized integration approaches, offering a practical, cost-effective, single-system solution for managing instruments that can be integrated with a lab's core scientific system such as an ELN or LIMS.
In essence, centrally maintained SOPs are driven to respective instruments to guide measurement and store all raw and processed data with corresponding metadata sets for future analysis.
Flexible data management
In a system of this type, no computer or tablet PC is needed on or near the bench top. The balance or instrument touchscreen is able to deliver real-time, step-by-step guidance to the user according to SOPs using flexible workflow tools that take advantage of instrument-specific firmware. When ready to begin, the operator simply touches a shortcut or selects a workflow from the instrument. As noted, this type of bench-top management system eliminates significant error potential that comes both with routine performance of SOPs and manual data entry.
Typically, generated reports can be communicated directly to the oversight lab informatics system (LIS). Information can also be drop-transferred to an open Excel cursor, making all metadata immediately available for analysis. Metadata can also be exported as a .csv or XML-formatted file. Finally, using API web services, extensive data sets can be exchanged bi-directionally with a platform of this type and other software systems, instruments and mobile devices. This, in effect, creates one functional system for truly flexible processing.
A two-way (data) streetPerhaps most importantly, this two-way street offers more than just results-management. It allows the sending of product data and sample series data from the lab informatics system (LIS) to the instrument. Information can be imported from a file location and exported to an open folder. This creates seamless instrument and task control, as seen in the graphic below:
As described, this kind of robust communication of workflows, transfer of results and immediate access to metadata eliminates manual transcription and transcription error-checking (the so-called “four eyes” principle). The elimination of a paper process also assures a coherent audit trail. This makes it easier for labs in regulated industries to comply with Good Laboratory Practice, Good Manufacturing Practice and Food and Drug Administration guidelines and standards.
An easier, faster process to operate instruments
In addition to compliance enhancements, common processes become easier and faster. A process starts when a user selects a substance to be handled then logs onto the system at the instrument touchscreen. There is no need to log onto a separate workstation to access each instrument, allowing single point process strat. All actions and results are recorded in the database against the user’s identity, using a time and date stamp. An attached printer can produce a label for the sample in process that contains requisite quality or regulatory information such as identity, concentration, and expiry date. The process can be further simplified if enabled for an attached barcode reader.
In conclusion, integrating instrument control software with informatics systems using .csv files, XML structures or API web-services closes gaps in traceability, simplicity, and efficiency. This lets labs take full advantage of instrument technology which, in many cases, already resides on their bench top to generate improvements in results tracking, quality compliance, data integrity and workflow efficiency.