An enhanced strategy for data integrity — the challenge
The laboratory analyst must often comply with standard operating procedures (SOP) for each analysis and document the entire process as well as record the results. While many labs have turned toward LIMS and ELN systems with the idea of replacing the manual workflow, these systems are designed primarily to aggregate result data from an array of analytical tests, not automate and document benchtop workflows or bind instrument metadata to the measurement.
As many organisations have discovered, workflows behind benchtop analytical instruments (such as balances, titrators, pH meters and similar instruments) and the associated metadata are much more complex than just the transfer of a few parameters. Complicating matters further, regulatory standards such as FDA (21 CFR Part 11), EU (Annex 11), GMP and ISO (ISO 17025) have recognised both the advantages and limits of electronic data systems, and have increasingly established further controls for the use of such systems all the way down to benchtop instruments. The goal of reducing errors, simplifying processes and reinforcing compliance can become even more challenging when trying to directly integrate and automate the lab benchtop.
Take the example of a weighing ‘loss on drying’ application, where weighing, calculations and sample tracking must be accomplished. Capturing only limited measurement data electronically without the full metadata set (instrument, user, tare vessels, sample qualitative data, calibration history, SOP, method version, etc) leaves the measurement without context and misses the objective. It is soon discovered that the process cannot be effectively managed without some degree of workflow interaction with the balance itself.
What is needed is a ready-made, configurable solution that drives the workflow SOP directly through the balance or instrument and delivers automatic, integrated instrument management and data capture functionality to improve productivity and efficiency by centring the work on the instrument. Mettler-Toledo introduced LabX software to deliver a single-vendor platform solution to the benchtop integration challenge.
Use of LabX instrument control and workflow software forms the foundation of the IT hierarchy and creates a fully self-contained system with the balances and instruments at the benchtop layer. Centrally maintained SOPs are driven by LabX to the respective instrument to guide measurement and data capture and to store all raw and processed measurement data with corresponding metadata sets for further use. The benchtop layer in turn can interact on a unidirectional or bidirectional basis with the other layers in the IT hierarchy using standardised integration approaches.
With LabX, laboratories have a practical, automated solution for managing instruments and measurement data together in a single system that can be integrated further with the lab’s core scientific systems, such as ELN or LIMS. The LabX software system works with the instrument firmware, helping it to remain the centre of the experience for the user working at the bench.
In a LabX system, no computer or tablet PC is needed on or near the benchtop. Driven from LabX, the balance or instrument touch screen delivers real-time, step-by-step workflow guidance to the user according to the lab’s own SOPs. SOPs are easily configured with the flexible workflow tool that takes advantage of the balance and instrument-specific features present in each model’s firmware.
When ready to begin work, the analyst simply touches a shortcut or selects a desired workflow from a selection on the balance or instrument. When complete, data can be analysed in LabX on a networked PC in the lab or office, reports can be generated and data can be sent to the LIMS. In comparison with manual transcription of data, a variety of possibilities exist for integration which bring with them various degrees of data transfer capability, regulation support and user guidance.
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