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Power the BenchAn Enhanced Strategy for Data Integrity

Acquire workflow control, traceability and data automation with laboratory bench top instruments and balances fully integrated in the Lab environment.

Contents Page1 The intention and reality 2

2 The challenge 2

3 Power the Bench, a better approach 4

4 Summary 10

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Fig.2 Adding pasted printouts Fig.3 Results electronically capturedFig.1 Paper notebook

1 The Intention and the Reality

One of the primary motives driving organizations to purchase Laboratory Information Management Systems (LIMS), electronic laboratory notebook systems (ELN's) and recently, Lab Execution Systems (LES) [collectively, Laboratory Informatics Systems (LIS)] is the appeal of connecting laboratory instruments to them for electronic data collection. Connectivity is typically pursued directly via the LIS and, in turn the LIS integrated with other core data systems with the aim of acquiring more efficient, secure, and robust data-collection, look-up, and management reporting capabil-ities – key objectives for many lab organizations. When a laboratory instrument is directly connected for electronic data capture, the costs in time, labor, 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.

2 The Challenge

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) estab-

lished for the result, the most recent calibration date and result, etc.• Balance performance history and trending ascribed to the samples and results.

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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 poten-tial 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 sys-tems 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 instru-ments (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 lim-its 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.

Taking the example of a weighing loss on drying application where multiple, sequenced weighing, calculations, and sample tracking must be accomplished, capturing only limited measurement data elec-tronically 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 with-out some degree of workflow inter-action with the balance itself.

In the attempt to solve this challenge, the next struggle for the organization is typically encountered – the neces-sity to create and maintain custom programming for enterprise and best-of-breed LIS systems for workflow and other metadata capture and quality controls needed for balances and instruments. This often results in the con-cept of driving the SOP/workflow directly to an adjacent PC screen with keyboard (or electronic tablet) for analyst guidance and further data input. However, placing a computer next to each balance or instrument is typically neither practical nor efficient from a space, usability, or cost viewpoint, and use of mobile tablets still involves careful attention from the analyst to prevent data entry error and can hinder efficiency. Additional concerns such as cross-contamination and constraints for clean rooms, balance rooms, or production areas where instruments are often located can also further restrict the use of computers and keyboards resulting in alternate approaches

The manual approach of documenting, calculating, and transcribing results, without user guidance.

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nch for these instruments. Such custom-coded attempts and 'one-off' scenarios can lead to significant initial deploy-

ment delays and drive up costs contributing to an overwhelming total cost of ownership (TCO). Since customiza-tions for workflow and process changes, instrument model and firmware changes, and version upgrades never seem to end and can require costly validation and revalidation and training, many such projects are either can-celled completely, are 'delayed' due to explosive TCO, or if somehow get implemented, are too awkward to use and negatively impact original objectives such as improving productivity.

One of the key “wants” of the industry is to have a "self-contained" direct connection between the actual analyti-cal instruments in the lab and the LIS that is fast to implement, easy to set-up and maintain, and that captures all needed measurement data along with all corresponding metadata according to the organization's SOP's. This eliminates time and cost needed to implement and maintain instrument connectivity in both new and legacy LIS deployments.

3 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 centering the work on the instrument. This, while helping the analyst per-form 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 guid-ance 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.

Fig.4 Workflow and Instrument control software

LabX Bench top Instrument Layer

As shown in Fig.4, 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 us-ing standardized integration approaches based on the needs of the organization. With LabX, laboratories have a

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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 sys-tems. 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 de-sired. The successful, on-time completion of these quality activities may be set as a prerequisite within a work-flow so that the analyst may begin work only if all quality activities have been satisfied. This prevents measure-ments 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.

Bench top balances and instruments with complete SOP guidance - results automatically sent to a variety of integrated systems.

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 center of the experience for the user working at the bench.

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Pow

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nch Implementing LabX under Various Scenarios

1. Adding instrument control software to existing lab systems circumvents the need to custom code for workflow automation. If there is an existing LIS in use at a lab, it is easy to add the approach to gain flexibility and data traceability as described above. Integrating LabX within existing IT infrastructures (i.e., LIMS or ELN) can provide "plug and play" compliant workflow automation and data capture. This allows organizations to get more out of their LIS by eliminating the interface customization to each instrument. The entire system can then be up and running in days to weeks instead of a year or more otherwise needed to define, program, and validate the system.

2. The important big picture of Total Cost of Ownership is also a decisive advantage to this approach when factoring the cost and time to update, reprogram, validate and train users. LabX maintains its own drivers and internal instrument controls for each instrument type and model with an intimate know- ledge of each balance and instrument workflow capabilities engineered into the workflow tool. The ex- tensive application know-how of the instrument manufacturer is incorporated into the software as well with all elements retained at the instrument layer of the IT hierarchy providing the organization with an instrument and software solution that has been engineered as a single system and is supported by one vendor.

3. One of the major “custom coding” interface challenges for organizations with legacy LIS technology is the direct interface and data transfer of data from instruments in the lab. The LabX interface allows instru- ments (e.g. balances, pH meters, titrators, refractometers, etc.) to be easily added to the network. Using the LabX client/server approach, each instrument is controlled centrally and therefore integration and updating is done once for multiple instruments quickly and efficiently without custom programming.

Advantages of LabX software on the bench topData Acquisition Data is automatically transferred to/from the instruments eliminating

transcription errors and increasing productivity via direct data capture. Eliminates need for second person verification in regulated environ-ments.

SOP Management SOPs are pushed to the appropriate instrument in real time from a cen-tral server assuring the correct workflow and version is used and traced for each selected task and across all balances and instruments.

Workflow Set up and assign workflows to individual operators and instruments either directly in instrument software or import them from an external system.

Data Securitiy & Access Control All data is maintained on a server that fully supports compliance to 21 CFR Part 11 and other regulatory standards. Access controls allow rights and permissions to be set for performing laboratory tasks and accessing data.

Complete LAB Ecosystem Import and export options using common .csv file formatting, industry-standard XML language, or well documented and flexible web services API allows seamless transfer of data into existing networks, data ar-chives, LIMS, ELN, ERP and other knowledge management systems 

Sample Management Traceability all the way back to the origin of the data (e.g. from a Balance) for each sample. All important meta-data to support best practices, lean lab, and regulations.

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Depending upon which instrument and workflow is required there are several ways of integrating bench top in-struments. Questions to consider in determining the right solution for the organization include:• Which action triggers the process?• When is the data transferred? How is the data transferred?• What level of instrument control is needed?• How does the user need to interact with the system?• What amount of meta-data is required?• Some potential solutions depend on more specific requirements: • Will results be accessed by a lab system from automatic .pdf reports? • Will results be automatically transferred in .csv or .xml format to common folder? • Will bi-directional data automatically transferred in .csv or .xml format to and from lab systems and instruments? • Will bi-directional data automatically be transferred with full instrument control located in the other lab system (ELN, LIMS, ERP, SAP…)?Each method of integration brings with it various degrees of data transfer capability, regulation support, and user guidance. In comparison to manual transcription of data from the instrument, each type of integration offers various benefits at each level. Depending on the requirements of the lab, regulation, users, and business model there is an integration to meet the needs of the lab.

LabX(LIS) Lab systems direct to instrument

Drop transfer

.pdf transfer

Peripheral communi-cation

Auto import/export

API web services

Full bi-directional data transfer √

Control complete process from LIS or instrument

√

Connect LIS ID to sample data √ √

Interface with data systems and inventory

√ √ √

Meta data (important sample and instrument data)

√ √ √ √

Integrate to any system √ √ √ √

User Management √ √ √ √ √

Updated firmware and instruments supported

√ √ √ √ √

Traceability √ √ √ √ √

SOP guidance √ √ √ √ √

Instrument control √ √ √ √ √

Support regulation compliance √ √ √ √ √ √

Improve efficiency √ √ √ √ √ √

Remove transaction errors √ √ √ √ √ √

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Pow

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nch Definitions of the typical ways of transferring data of integrated systems:

Manual data transfer Work on the instrument according to SOP written on paper. Make calcula-tions manually, write results in a lab notebook, and enter the values back on the instrument manually. Write results in lab notebook. Manually enter the results and information into the LIS. Store the lab notebooks on shelf for future audit usage.

(LIS) Lab Information Systems direct to instrument

Lab Information System vendor or integration company programs custom code to each driver of each instrument. Result value available typically when pressing print on instrument. Changes to instruments or updates to firmware or software often require reprogramming of custom code and revalidation efforts.

Drop transfer Using the 'Transfer Data' method function within a method; during the workflow data is transferred into an open cursor position in excel. Data can be sent to excel; all meta data is available (e.g. instrument informa-tion, user information, results...).

.pdf transfer As flexible and detailed as a report printed on a network printer, a .pdf report is created and stored in a folder on the network. Many LIS systems have the capability to read this .pdf data, import the files and input in to their system.

Peripheral communication Send and receive data from external systems during the workflow. Two way communication between instruments.

Auto import/export Export: Extensive meta data for results, products, and sample series can be exported as a .csv or XML formatted file. This file can be configured in various ways (e.g. after electronic signature, only if results are with toler-ance range, or simply automatically to any folder from which any other information system can import the file).Import: From most information systems send files in .csv or XML format for tasks, products, and sample series. LabX either manually or automatically runs or imports files as defined and required."

API webservices integration Using the common web services techniques, an extensive amount of data can be exchanged between LabX and other software systems, instruments, even mobile devices. Information, running methods and tasks, getting reports and complete data can be triggered by various external software systems or instruments at various points within the workflow. This is a true bi-directional communication and connects the systems together as close as possible as one system. In practice users can create and start tasks from either the LIS system or directly on the instrument touchscreen. All data flows back and forth through this expanded network of the system at multiple points as required by the Lab's working style.

LabX

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The path of the data can be considered a one-way or a two-way street. Depend-ing on the needed data and desired level of integration, the following paths could be followed:

Standard LabX using "transfer data" method

function

Standard LabX automatically

saves .pdf report

System Inte- gration option

(API web services)

Automatic import/export option

Only need results sent to LIS systemMore than just results. Need to send and receive data to

and from LIS

Excel accepts data sent to

selected field in open worksheet

LIS can import .pdf data

LIS can pick up .csv/XML file to

use in LIS

Send results to file in .csv or XML

Import from file location / export

to folder

Send product data and sample series data from LIS to the instrument,

and receive data back to LIS

Instrument and task control from

the LIS / send instru-ment and

result data to LIS

TWOWAY

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nch Finding answers to how the data will be used helps in determining

the level of integration needed:

4 Summary

Directly connecting laboratory balances and instruments to LIS systems offers significant advantages but imple-mentation can suffer from technical limitations and cost overruns with less than desirable results. Using instru-ment 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 touchscreen, net-worked PC, LIS, or remote lab system.

Transfer result data directly into

excel

Excel accepts whatever data is sent to the worksheet

LabX transfers data to open

excel worksheet

Flexible formatting and secure structure

of .pdf

Ability to import and read a .pdf report from a network folder

LabX automatically saves .pdf reports to network folders

Formatted result data imported in a standard

XML or .csv file

Import and use a .csv or XML file stored on

a network folder

Import and Export

data manually

Automatically send parameters and series data from LIS to the instru-ment and receive

results.

Send .csv or XML files to generate

tasks and receive result files from a network folder

Automatic and scheduled import and export of data

Bring instrument and workflow control to the

LIS. Create tasks from a LIS system using the workflow

guidance on the instrument

Use webservices to leverage the workflow and

instrument control of LabX and record results in the LIS.

System Integration with API

webservices

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 in-struments 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 tran-scription.

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 compli-ance, 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.

Mettler-Toledo AG, AnalyticalCH-8603 SchwerzenbachTel.: +41 44 806 71 11Fax +41 44 806 72 40

Subject to technical changes©01/2015 Mettler-Toledo AGGlobal MarCom Switzerland

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