Head of Process Analytics Division, Mettler Toledo
The Intention and the Reality
When a laboratory instrument is directly connected for electronic data capture, the costs in time, labour, and potential error associated with manual transfer of data are essentially eliminated. Organizations that do not address electronic integration of instruments and other core systems will find that transcribing data into the LIS or other system(s) can remain slow, expensive and error-prone. However despite the advantages and best intentions, direct-connection is not always implemented for a variety of reasons. Too often, perceived or actual complexity, lack of expertise, instrument variations, and infrastructure challenges encountered in connecting instruments and linking systems prevent realization of these goals.
In the face of compelling advantages, many instruments and systems still remain disassociated and data entry and transfer largely handled manually. When considering a typical laboratory, the equivalent of one Full Time Employee (FTE) per week is often employed for manual data transcription costing the organization efficiency losses and valuable personnel time. Manual data transcription and report creation keep the laboratory analyst from focusing on the science – the primary function of the laboratory. Frequently, the transcribed data often lacks missing elements and the traceability needed to satisfy internal quality management and regulatory mandates.
The end result is that time and revenue are lost due to the time and effort it takes laboratory analysts to resolve the situation by gathering missing data, re-transcribing results, documenting missing controls, and preparing reports so that the data can be acted upon to make informed decisions for the organization.
The laboratory analyst must often comply with the established standard operating procedures (SOP) for each analysis and document the entire process as well as record the results. Taking the laboratory balance as an example of one of the most common instruments targeted for direct connection to a LIS system, a typical work flow can typically include balance selection based on requisite specifications for accuracy, precision, and measurement uncertainty, verifying and documenting the calibration and readiness state of the balance, recording sample ID information, recording qualitative data about the sample, determining accurate zero, gross, net and tare weights, and performing calculations with the measurements, reporting final results, balance quality information (e.g. Uncertainty of Measurement (UOM) value) established for the result, the most recent calibration date and result, etc. as well as balancing performance history and trending ascribed to the samples and results.
Beginning at the balance, the sample data and measurement results are often handwritten in the traditional paper laboratory notebook or on various paper forms creating the potential for error. (Fig. 1) Some labs paste printouts from instrument strip printers into the paper notebook. (Fig. 2) Though this a small step better, the printed values are subsequently used in manual calculations or are in-turn handwritten reintroducing the potential for error. Further, managing the lab's quality assurance requires a well-documented 'paper trail' that links the measurement with all routine quality testing performed on each balance such as calibration and uncertainty of measurement (UOM) determinations – not to mention ensuring and documenting that each analyst performs the workflow consistently according to the SOP.
This is neither easy nor efficient to maintain or to report using paper systems, and the burden often remains with the analyst and the lab quality manager. Of course there are also varying degrees of semi-automation involving computer spreadsheet data entry and calculation, but these hybrid approaches often suffer from the same challenges. So 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 bench top workflows or bind instrument meta-data to the measurement despite supporting direct connection of balances and instruments.
As many organizations have discovered through further scrutiny, workflows behind bench top analytical instruments (such as balances, titrators, pH meters, and similar instruments), and associating the measurements and results from them with the control data from the workflows that correlate proper instrument selection, instrument suitability, user, and method, etc. (metadata) are much more complex than just the transfer of a few parameters as originally anticipated. Complicating matters further, regulatory and standards setting organizations such as FDA (21 CFR part 11), EU (Annex 11), GMP and ISO (ISO 17025) have recognized 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 bench top instruments. So the goal of reducing errors, simplifying processes, and reinforcing compliance can become further challenging and elusive to the user organization wanting to directly integrate and automate the lab bench.
Power the Bench – A Better Approach
What is needed is a ready-made, configurable solution that drives the workflow SOP directly through the balance or instrument, and that delivers automatic, integrated instrument management and data capture functionality to improve productivity and efficiency by centring the work on the instrument. This, while helping the analyst perform instrument tasks consistently, efficiently, and conform automatically to all established quality controls.
Until now, modern lab bench-top balances and instruments have not been leveraged to their full potential to accomplish this approach. Therefore with the expertise gained as a single-brand provider of the most frequently used laboratory bench top measurement instruments, METTLER TOLEDO introduced LabX software to deliver a single-vendor platform solution to the bench top integration challenge. LabX drives step-by-step method guidance directly to the analyst through the balance or instrument display. It was architected and engineered to form a single system that resides on the bench top that works transparently with popular models of METTLER TOLEDO analytical instruments already in use in laboratory environments worldwide. The system design is scalable to the lab, department, or organization - and even on a larger scale to multiple locations globally.
Use of LabX instrument control and workflow software forms the foundation of the IT hierarchy and creates a fully self-contained single system with the balances and instruments at the bench top layer. Centrally maintained SOP's 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 bench top layer in turn can interact on a unidirectional or bi-directional basis with the other layers in the IT hierarchy using standardized integration approaches based on the needs of the organization.
In a LabX system, the lab's bench top instruments are easily networked to a PC or server inside or outside the lab hosting the LabX software. No computer or tablet PC is needed on or near the bench top. 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 SOP's. SOP's are easily configured with the flexible workflow tool in LabX that takes advantage of the balance and instrument-specific features uniquely 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. The analysts' login using their ID and password and are then guided through the process. The user can be prompted to input alpha-numeric data such as ID, sample, and other information via touch screen entry, via a barcode scanner or automatically input from integrated lab systems. LabX captures full traceability to the instrument, method, and analyst performing the work and incorporates full user rights management. A complete log and audit trail of all user and system actions is maintained. All measurement and related data is maintained securely in the LabX database for immediate or subsequent reporting or for automatic transfer to other lab systems.
When complete, data can be analyzed in LabX on a networked PC in the lab or office, printed to a network printer, saved as .pdf, or sent to the LIS as .csv, XML or via a web services API. Elements of the instrument quality assurance history are easily incorporated into reports alongside results if desired. The successful, on-time completion of these quality activities may be set as a prerequisite within a workflow so that the analyst may begin work only if all quality activities have been satisfied. This prevents measurements from being captured from instruments outside their quality management constraints.
By installing LabX software, laboratories wishing to improve results, quality compliance, and efficiency through automation can take advantage of the instruments that are often already in the lab. Together, the system offers an easy-to-use, transparent user experience that uniquely addresses the challenges of bench top automation and integration. While a LabX system necessitates the use of compatible balances and instruments incorporating the requisite technology to work with the software, any replacement costs are almost universally outweighed by the savings in TCO of this approach supported by a single vendor maintaining the interfaces without reprogramming efforts. Often, organizations have a large inventory of balances and instruments already on the bench top that are ready for use with LabX due to the popularity of compatible models. practical, cost-effective, automated solution for managing instruments and measurement data together in a single system that can be used independently as a complete system, or which can be integrated further with the lab's core scientific systems such as ELN or LIMS. The LabX software system works uniquely with the instrument firmware, helping it to remain the centre of the experience for the user working at the bench.
Directly connecting laboratory balances and instruments to LIS systems offers significant advantages but implementation can suffer from technical limitations and cost overruns with less than desirable results. Using instrument control software such as LabX that incorporates the lab bench top balances and instruments to form a single "bench top environment" at the IT foundation level offers significant advantages and efficiencies compared to other approaches.
Integrating LabX instrument control software with other Lab Informatics Systems using .csv files, XML structure or the API web services closes the gap in traceability, simplicity, total cost of ownership (TCO), and cost/time efficiency. Any system that can handle .csv, .xml or web services can integrate directly with LabX and in turn, its connected instruments.
With LabX, bringing tasks directly to the instruments touch screen with bi-directional integration from various lab systems is possible for simple measurement data capture from balances and instruments to more advanced system integration. Start and control tasks from a variety of points such as from the instrument touch-screen, networked PC, LIS, or remote lab system.
There are some questions that need to be answered in order to deftly employ this approach. They are—How do I want to work with the data? How can the other systems work with my data? How does LabX answer this need?
Using the LabX workflow tool, centrally-configured and managed SOPs are ensured to run correctly on the instruments by the analyst every time. Analysts need to only push the shortcut on the screen and follow the user guidance based on the SOP. Managers are assured the workflow is followed consistently by all analysts, on a calibrated, tested and appropriately-selected instrument by the user. The analyst just clicks on the button which appears on the touch screen or simply scans a barcode to begin and follows the step-by-step guidance. There is no need for a computer in the lab for the common bench top instruments. All data is captured by LabX and in turn transferred to the LIS system automatically removing errors and omissions associated with manual transcription.
For lab systems, multiple bench top instruments now have a single integration point engineered and maintained by the same manufacturer of the instruments and software. The lab can benefit from the best of breed approach. That is, bench top instruments, instrument control software, and LIS, each doing what they are designed to do best, and working together to obtain the full advantages of each with minimal overhead on the user organization. By installing LabX software organizations wishing to improve weighing and analytical results, quality compliance, and efficiency through automation can take advantage of the instrument technology which in many cases, already resides on the bench top. Together, the system offers an easy-to-use, transparent user experience that uniquely addresses many challenges of the user organization. METTLER TOLEDO provides full support services for easy start-up and can assist with guidance on establishing and maintaining effective quality management programs to compliment a LabX installation.
AUTHOR BIO: Waldemar Rauch has been the Head of Process Analytics Division in Mettler Toledo since January 2008. Prior to joining the company he worked in R&D at Siemens in Germany and held various technical management positions with Atomika Instruments in Germany as well as with Endress + Hauser Flowtec, a leading Swiss supplier of industrial measurement and automation equipment.