Data Integrity Guide

Data Handling
SOP Guidance
Practical Examples

Secure Your Measuring Processes

with LabX Software
 Editorial

2 METTLER TOLEDO Data Integrity Guide

Editorial

Dear Reader,

One of the primary motives driving organizations to purchase a LIMS, ELN, or LES
[collectively, Laboratory Informatics Systems (LIS)] is the appeal of connecting laboratory
instruments to them for electronic data collection. 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. However, even with the compelling
advantages, many instruments and systems still remain disassociated and data entry and
transfer are largely handled manually.

Manual data transcription and report creation keep the laboratory analyst from focusing on
the science. Frequently, the transcribed data is 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.

METTLER TOLEDO

Disclaimer
The information contained in this guide is based on the current knowledge and experience of the authors. The guide
represents selected, possible application examples. The experiments were conducted and the resulting data evaluated in
our lab with the utmost care using the instruments specified in the description of each application. The experiments were
conducted and the resulting data evaluated based on our current state of knowledge.However, this guide does not absolve
you from personally testing its suitability for your intended methods, instruments and purposes. As the use and transfer of
an application example are beyond our control, we cannot accept responsibility therefore.
When chemicals, solvents and gases are used, the general safety rules and the instructions given by the
manufacturer or supplier must be observed
 Content
Content
1 An Enhanced Strategy for Data Integrity 5
1.1 The Risk of Incomplete Data 5
1.2 The Daily Challenge 5
1.3 Finding the Best Approach 6
2 An Example for Weighing 10
2.1 The Way Many Labs Work Today 10
2.1.1 Process Flow Figures Explained 10
2.1.2 Overview of the Weighing Processes 11
2.2 Process 1: Weighing and Recording by Observation 11
2.3 Manual Process and Multiple Transcription Error Checks 12
2.3.1 Transcribing Data and Transcription Error Checking Are Error-prone 12
2.3.2 Lack of a Data Audit Trail 12
2.3.3 Failure to Meet GLP, GMP and GAMP Regulatory Requirements 13
2.4 The Way Labs Could Be Processing Data 13
2.5 Process 2: Weighing with a Printer Attached to the Balance 14
2.5.1 Process Improvements 15
2.5.2 Process Meets Regulatory Expectations 15
2.6 Process 3: Weighing Using LabX Server Software 16
2.7 Comparison and Summary of the Three Ways of Working 17
2.8 Validation of an Electronic Process 20
3 An Example for BRIX Determination 21
3.1 The Workflow of Smart Standard Preparation 21
3.2 Seamless Workflow from Balance to Refractometer 21
3.3 The Benefits of this Workflow over Stand-alone Instruments 23
4 An Example for Titration 24
4.1 Efficient and Error-free Titration Workflows 24
4.2 Automated Data Transfer 24
®
4.3 Automatic Method Selection with LabX SmartCodes 25
4.4 New Level of Data Integrity 25
5 Summary
26
6 References 26
7 Additional Supporting Information 27
7.1 Webinars 27
7.2 Comprehensive Application Support 27
7.3 Lab Library 27

4 METTLER TOLEDO Data Integrity Guide

1. An Enhanced Strategy for Data Integrity

1.1 The Risk of Incomplete Data

For laboratories that must comply with GLP, GMP and GAMP regulations it is important to have records or
documented evidence of all relevant analyses that can be checked by a second person and also readily
available for audits. Storing the result is not enough, each result set has to be complete and contain all relevant
meta data.

In 2016, 80% of the FDA warning letters were issued due to the lack of data integrity. The main reason was
incomplete data, an aspect that can be prevented by using the right solutions. The highest risks, when not
working in a compliant manner, lie in import ban, product re-call or closing of production plants.

1.2 The Daily 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, and not to automate and document bench top workflows or to bind
instrument metadata to the measurement. As many organizations have discovered, workflows behind bench
top analytical instruments (such as balances, titrators, pH meters, and similar instruments), and the associated
results, instrument information, user information, and method applied, etc. (metadata) are much more complex
than just the transfer of a few parameters. Complicating matters further, regulations and standards 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 when trying to directly integrate and automate the lab bench top.
Taking the example of a weighing 'loss on drying' application where multiple, sequenced weighing, calculations,

(*) LIMS = Laboratory information and management system, ELN = Electronic laboratory notebook

METTLER TOLEDO Data Integrity Guide 5

 An Enhanced Strategy for Data Integrity

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.

1.3 Finding the Best 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. With the expertise gained as a
single-brand provider of the most frequently-used laboratory bench top instruments, METTLER TOLEDO
introduced LabX software to deliver a single-vendor platform solution to the bench top integration challenge.

LabX Bench Top Instrument Layer

Figure 1: Workflow and Instrument control software

6 METTLER TOLEDO Data Integrity Guide

As shown in Figure 1, the 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 bench top 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 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. With LabX, laboratories have a practical, cost-effective,
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 uniquely with the instrument firmware, helping it to
remain the center 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 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 SOPs. SOPs are easily configured with
the flexible workflow tool 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. When complete, data can be analyzed in LabX on a networked PC in the lab or office, reports generated, and data sent to the
LIS as .csv, .xml or via a web services API.

In comparison with manual transcription of data, a variety of possibilities exist for the integration which bring with them various degrees
of data transfer capability, regulation support, and user guidance.

LabX
(LIS) Lab Drop .pdf trans- Peripheral Auto API web
systems transfer fer communi- import/ services
direct to cation export
instrument
Full bi-directional data transfer √
Control complete process √
from LIS or instrument
Connect LIS ID to sample data √ √
Interface with data systems √ √ √
and inventory
Metadata (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 √ √ √ √ √ √

Table 1: Variety of integration possibilities

METTLER TOLEDO Data Integrity Guide 7

 An Enhanced Strategy for Data Integrity Manual data transfer Work on the instrument according to SOP written on paper. Make
calculations 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 Lab Information System vendor or integration company programs custom
Systems direct to code to each driver of each instrument. Result value available typically
instrument 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
information, 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
LabX

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
tolerance 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.

Table 2: Definitions of the typical ways of transferring data of integrated systems

8 METTLER TOLEDO Data Integrity Guide

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

TWO
WAY

More than just results.

Only need results sent to LIS system Need to send and receive data
to and from LIS

Excel accepts LIS can import LIS can pick up Send product data Instrument and
data sent to .pdf data .csv/XML file to and sample series task control from
selected field in use in LIS data from LIS to the LIS / send
open worksheet the instrument, instru-ment and
and receive data result data to
back to LIS LIS

Send results to file Import from file

in .csv or XML location / export
to folder

Standard LabX Standard LabX System Inte-

using "transfer automatically Automatic import/export option gration option
data" method saves .pdf (API web
function report services)

Table 3: Levels of integration

METTLER TOLEDO Data Integrity Guide 9

 An Example for Weighing 2. An Example for Weighing

2.1 The Way Many Labs Work Today

In this section we will look at how an analytical balance is used for common weighing operations and highlight
where potential errors and problems might occur.

Let us look at the instruments, tools, and the process that we will discuss.

The process described here is the preparation of an analytical reference standard solution by weighing an
amount of a reference standard, transferring it to a volumetric flask, dissolving it and making up to volume. This
is a typical use of an analytical balance in all laboratories involved in quantitative analysis.

This will be achieved, depending on the way the process is performed, by using some of the following items:
• Analytical balance with or without a thermic printer attached
• Laboratory notebook (also called lab journal) for recording the work and summarizing the results
• Calculator or spreadsheet for calculating the concentration of reference standard after adjustment for factors
such as purity or conversion from salt form to base weight.
• LabX Laboratory software used to automate the process and record the results directly in the application’s
database. The software will be operated using the screen on the balance and work will be tracked by the audit
trail in the software. Finally, reports will be signed electronically with an option to print the report if required.

2.1.1 Process Flow Figures Explained

Figures 2 to 4 in this guide are cross-functional process maps or “swimming lanes.” Each of the lanes
represents the work carried out by an item in the list above, for example the analytical balance, spreadsheet,
LabX, or a laboratory notebook. Activities occur in the lane for that item, e.g. weigh an external mass or tare the
weighing vessel for the balance. Where the process crosses from one lane to another it represents an interaction
between two parts of the process, e.g. weigh a sample on the balance and record the observed balance weight
in a laboratory notebook. The overall time for the process starts at the top of the figure and ends at the bottom.

10 METTLER TOLEDO Data Integrity Guide

2.1.2 Overview of the Weighing Processes
The three processes described in this guide assume that there is a standard operating procedure or work
instruction for the preparation of a nominal concentration of reference standard and therefore the amount of
reference material to be weighed is known. The instructions will typically describe that an amount to be weighed
must be within a range of acceptable values. Once the weight of the standard is known an analyst will then
calculate the actual concentration as opposed to the nominal concentration of the solution.

If there are no instructions available, then an analytical scientist is required to prepare a reference solution from
first principles. In this case an additional calculation step is required to determine the amount of standard to be
weighed and the volume that the substance must be dissolved in.

The processes also describe a vessel in which the reference standard is weighed. This can be a weighing
boat or directly into a volumetric flask depending on the working practices of an individual laboratory.
However, modern analytical balances allow the safe and ergonomic positioning of tare containers to avoid any
intermediate containers and corresponding weighing errors. METTLER TOLEDO recommends SmartGrid weighing
pan and ErgoClips vessel holders.

2.2 Process 1: Weighing and Recording by Observation

Shown in Figure 2, below, is the process flow for weighing the reference standard where the values are recorded
by observation from the balance screen and written into a laboratory notebook (journal) by an analyst.

The subsequent calculations are performed using a Manual Process without a Printer
hand-held calculator with the results also written
directly into the analyst’s laboratory notebook. The Analytical Balance Lab Notebook Calculator

volumetric flask is labeled by hand to identify the Prepare notebook

solution, preparation information, and the expiry for standard
preparation
date of the solution.
Check balance Document checks
and tare vessel in lab notebook
The process begins by writing up the work to be done
in the laboratory notebook and checking that the Weigh reference Observe weight
correct reference standard to be prepared has been material and record in lab
selected. Next the balance is checked with an notebook

external calibration mass. The balance and calibration Remove vessel Prepare and label
standards used are recorded in the lab notebook by and tidy balance standard solution
the analyst. Then the weighing vessel is weighed Locate factors to
and the balance tared. be used e.g.
purity

The reference material is weighed on the analytical Calculate

balance and the reading on the screen is observed concentration
and recorded in the lab notebook by the analyst. Transcribe value
into notebook

When completed, the vessel is removed and the balance

Check value and
is cleaned and tidied ready for the next user. The reference results, then sign
material is transferred to the appropriate size volumetric page
flask and liquid added to prepare the reference solution. Corrections
Second person
Then the flask is inverted to dissolve the analyte and then checks SOP, data
made up to volume. and results

Second person
signs lab
notebook pages

Figure 2: Cross-functional process workflow for manual

observations from an analytical balance

METTLER TOLEDO Data Integrity Guide 11

 An Example for Weighing The flask is labeled by hand with the standard identification number, substance information, calculated
concentration, analyst who prepared the solution, storage conditions, and the dates of preparation and expiry.

The analyst uses any factors such as purity or water content to calculate the actual concentration of the
reference standard solution. The calculations and conversion factors used are recorded in the lab notebook.
The calculation is performed using a hand-held calculator; the analyst reads the final value from the calculator
display and transcribes it into their lab notebook.

The analyst checks the data and results, including repeating the hand-held calculation, and if correct signs the
relevant pages of the lab notebook.

If there any deviations from the procedure or instructions, the analyst must record them in their laboratory
notebook.

A second person reviews the data and procedure to confirm that all data are correct and then signs to approve
the work. If there are any corrections, the first analyst will do this and return for approval.

2.3 Manual Process and Multiple Transcription Error Checks

Owing to the manual nature of this process it will be tedious to operate and error-prone. Let us examine in more
detail some of the key areas where errors could occur.

2.3.1 Transcribing Data and Transcription Error Checking are Error-prone: Quality standards (e.g. ISO 17025)
and pharmaceutical industry regulations use the four eyes principle when performing work: one person performs
the work and a second independent person reviews it. This principle is based on the idea that four eyes are
better than two. However, as the process is performed by humans it is error-prone in its own right. So this
manual process is not perfect and typographical errors could be missed in the second person review, especially
if the individual is under pressure with other tasks to perform.

2.3.2 Lack of a Data Audit Trail: In essence there is no paper audit trail; this process relies on the ability of
the analyst performing the work to accurately record the values displayed on the balance and calculator, and
transcribe these results into the laboratory notebook without error. Only the calculator result can be replicated by
keying in the data and performing the calculation again. Unfortunately, as the process is operated by humans,
even highly trained humans, it is subject to errors. What the brain thinks it has seen and recorded may not be
the actual value on the balance or calculator. The second person cannot check the actual balance reading,
which is the major failure point of this process.

12 METTLER TOLEDO Data Integrity Guide

2.3.3 Failure to Meet GLP, GMP and GAMP Regulatory Requirements: For laboratories that must comply with
GLP, GMP and GAMP regulations it is important to have records or documented evidence that can be checked
by a second person and is also available for inspection. The method of working described in Figure 2 is
unacceptable to FDA inspectors, as noted by this warning letter citation:

Your firm failed to ensure that laboratory records included complete data derived from all tests necessary
to assure compliance with established specifications and standards (21 CFR 211.194(a)). For example, your
firm did not retain any raw data related to sample weights and sample solution preparations for the
HPLC assays of <redacted> tablet batches <redacted> and <redacted> that you conducted on July 18, 2012.
FDA Warning Letter, May 2013.

The major issue is that the balance result cannot be verified – in fact the analyst could just write down anything
and say the work was performed. Over 20 years ago the FDA advised their inspectors when looking at weighing
results from analytical balances and preparation of standard solutions:

Carefully examine and evaluate laboratory logs, worksheets and other records containing the raw data
such as weighings, dilutions, the condition of instruments, and calculations. Note whether raw data are
missing, if records have been rewritten, or if correction fluid has been used to conceal errors. Results should
not be changed without explanation. Cross reference the data that has been corrected to authenticate it.
[Ref 1]

Review records of standard solution preparation to assure complete and accurate documentation. It is highly
unlikely that a firm can “accurately and consistently weigh” to the same microgram. Therefore data
showing this level of standardization or pattern is suspect and should be carefully investigated. [Ref 2]

Therefore, to comply with GxP regulations and avoid intimidating questions from an inspector, a regulated
laboratory needs to have at least a printer attached to the balance to record the weights of reference standards
and samples in the course of analysis. The advantages of this approach from regulatory compliance and
laboratory efficiency perspectives will be reviewed in the next section.

2.4 The Way Labs Could Be Processing Data

To help eliminate sources of error the process needs to be automated. Here there are two alternatives that we will
discuss in this white paper:

1. Using a thermic technology printer attached to the analytical balance. The remaining items used are the same
as in the previous section. Although the process is still manual there are records available that can be inde-
pendently checked by a second person. Thermic technology can print both thermic and normal paper labels.
The major advantage of thermic paper is that it is very stable and has high resistance to plasticizers, oil, fat,
and water. This makes it more robust than paper and allows for an archive time of 25 years. In addition the
printer is very fast, very quiet and, if required, can also be used in a clean environment as it does not produce
any airborne dust, unlike paper printers.

2. Using LabX to convert a manual process to an electronic one. The application is configured once to prepare
reference standards and perform the requisite calculations. To aid compliance, all user actions are recorded in
the audit trail and electronic signatures are used by the analyst and a second individual to review and approve
the results. This makes the process fully electronic and has all data in a single location.

METTLER TOLEDO Data Integrity Guide 13

 An Example for Weighing 2.5 Process 2: Weighing with a Printer Attached to the Balance
In this process, shown in Figure 3, the main changes are the addition of a thermic printer to record results
contemporaneously from the printer, and the substitution of a validated spreadsheet for the handheld calculator.
This allows the process to be more efficient but, more importantly, less error-prone than process 1 with the
added bonus of a regulatory or quality paper trail.

In the same way as the first process started, the lab notebook is written up for the work to be performed and the
correct reference standard is selected.

Next, the balance is checked and the weighing vessel is weighed and tared. The values are printed out on the
printer together with the date and time of the activity.

Then the reference standard is weighed on the analytical balance and the reading is recorded on the printout.
Adding the printer avoids the need for the analyst to record this information in the lab notebook.

When completed, the vessel is removed and the Manual Process with a Printer
balance is cleaned and tidied ready for the next Analytical Balance Lab Notebook Calculator
user. The reference material is transferred to the with Printer
appropriate size volumetric flask and the standard
Prepare notebook
solution prepared. The balance can print a label for for standard
the reference solution containing all quality and preparation
regulatory information to save the analyst performing Check balance
and tare vessel
this task manually. Record weights
via printer
The balance printout is removed and the analyst
Weigh reference
inputs the actual weight of the reference substance
standard Record
into the spreadsheet together with any correction weights via printer
factors such as purity or salt to base conversion to
calculate the concentration of the reference standard Remove vessel Prepare and label
and tidy balance standard solution
solution automatically. The spreadsheet is then
printed out and the analyst pastes the balance and Weight entered
Remove printout into spreadsheet
the spreadsheet printouts into the lab notebook.
Locate factors to
The analyst checks the data and results. This check be used e.g. pu-
rity and enter into
is more complete than process 1 as all the data are
spreadsheet
available on the two printouts. The calculation need
not be repeated or verified as the spreadsheet is Calculate concen-
validated. Once the data checks show the data are tration using
correction factors
correct, the analyst signs the relevant pages of the lab
Stick printout into
notebook. lab notebook

The second person review becomes more relevant as Check values and
results, then sign
there is now a complete data trail to follow and page
demonstrate that the procedure was followed and that
Second person
all data are correct. The reviewer signs the lab notebook.
checks SOP, data
This second person check is faster than the previous and results
process as there are no hand-held calculations to be Corrections
Second person
performed. signs lab
notebook pages

Figure 3: Cross-functional process workflow for an analytical

balance with printer attached

14 METTLER TOLEDO Data Integrity Guide

2.5.1 Process Improvements
As seen in Figure 3, there are a number of improvements that are apparent in the new process over that shown
in the manual process of Figure 2:

Data Integrity: The integrity of the data generated in this process has improved: the original weighing results
are available on the balance printout together with the date/time and the name of the analyst.

Paper Audit Trail: As a consequence of improved data integrity the audit trail is complete, as the original
results can be traced from the balance printout to the spreadsheet for calculation of the standard concentration.

Error Reduction: Transcription errors from the balance and calculator readings have been eliminated by the use
of the balance printer.

Improved Speed of Process: Manual calculations by the analyst and the reviewer have been eliminated, with
the spreadsheet speeding up this part of the process. Second person review of the data is quicker and more
meaningful as there is a complete audit trail of data.

2.5.2 Process Meets Regulatory Expectations: Use of the balance printer enables improved data quality
and permits an audit trail of data from the weighing of the reference standard to the calculation of solution
concentration. This allows a regulated laboratory to meet GLP/GMP expectations [Ref 1, 2] and avoids the
warning letter citation shown in the last section.

Disadvantages of the Process

Despite the improvements there are still parts of the process where errors can occur and further optimization
of the process is possible.

Manual Data Entry to the Spreadsheet: Transcription error checking is not eliminated as the balance result and
any conversion factors have to be entered into the spreadsheet. These figures must be checked by the analyst
and the reviewer to ensure that they are correct.

Paper Based Process: As Figure 3 makes apparent, the process is paper based. There are two printouts that
are produced and pasted into the laboratory notebook to form the analytical record. This, together with the
preparation and summary of the work that needs to be written by the analyst, results in a slow process.

To improve the process further and to eliminate the transcription check we need to consider working
electronically, as we shall see when we look at Process 3 in the next section.

METTLER TOLEDO Data Integrity Guide 15

 An Example for Weighing 2.6 Process 3: Weighing Using LabX Server Software
In this process the lab notebook, the spreadsheet and the associated printouts have all been replaced by
METTLER TOLEDO’s LabX software. The LabX software has the technical controls for ensuring data integrity
to comply with GLP/GMP regulations for electronic records and electronic signatures [Refs 3, 4].

However, the function of more importance to regulated Electronic Weighing Process

and non-regulated laboratories alike is the ability to LabX Analytical Balance Lab Notebook
sign records electronically. Whilst a non-regulated
laboratory is not concerned about compliance with Log onto LabX via
balance screen
pharmaceutical industry regulations, cost-
consciousness and improvements to analytical Start standard
laboratory processes are still relevant topics, and preparation
procedure
this is where LabX software can help.
Weights recorded Check balance
Implementing LabX allows the process to be made in LabX database and tare vessel
fully electronic. It eliminates the last source of
Weight recorded Weigh analytical
transcription error, improves data integrity and quality, in LabX database reference material
speeds up the overall process, and reduces time
needed to perform a task. Automatic calcu- Remove vessel
lation of concen- and prepare
tration using cor- solution
LabX is a configurable software application and the rection factors
SOP for preparing a standard solution can be
incorporated in an electronic process and validated, Print label for
volumetric flask
thus enforcing compliance with the written procedure.
Analyst electoni-
The LabX electronic process starts by the analyst cally signs the
selecting the reference standard to weigh and then calibration report
logging onto LabX at the terminal of the analytical
Second person
balance. There is no need to log onto a separate Optional process Print report and
electronically
workstation to access LabX. signs the past in lab
calibration report notebook

Balance checks must be performed if prompted by

LabX. Otherwise the analyst takes the weighing vessel Figure 4: Cross-functional process workflow for an analytical
and tares the boat, then weighs the reference material. balance connected to LabX software

16 METTLER TOLEDO Data Integrity Guide

No results are recorded by the analyst as LabX does all the work: actions and weights are recorded in the
database against the user’s identity, together with a time and date stamp.

Dissolving of the reference material in the volumetric flask and making up to volume is carried out by the
analyst. A printer attached to LabX can produce a label for the volumetric flask containing the requisite quality or
regulatory information such as identity, concentration, expiry date, etc.

When complete, the validated process simply needs the analyst to electronically sign what has been done. The
reviewer’s tasks in an electronic system are greatly simplified as the process is enforced by the software.
No checks for transcription or calculation errors are required, as the whole process and records are held within
a single system. Once the data are checked they can be electronically signed.

There is an option to print out the record, although this is not strictly necessary unless required by local
procedures or practices.

Advantages of the Electronic Process

There are a number of advantages to the electronic process shown in Figure 4:

1. Elimination of Manual Data Entry: There is no manual data entry in the process; all data are captured via
LabX server.

2. Elimination of Transcription Errors: All transcription errors have been eliminated, which improves on the
situation with the other two processes shown in Figure 2 and Figure 3. Now there is a single process controlled
by LabX with automatic data capture that eliminates any human recording of data. The analyst can focus on
scientific work rather than clerical tasks.

3. Single System Log-On: Interfacing an analytical balance to LabX turns its display screen into a terminal
for interaction with the software. A user logs on to the system via the balance screen rather than at a separate
workstation; no separate terminal is necessary for operating LabX.

4. Fast, Efficient Process: The electronic process is faster than the paper based ones and therefore saves
laboratory time and effort.

Barcoding to Eliminate More Manual Data Entry

METTLER TOLEDO’s new P-58 printer is capable of printing various symbology (e.g. code 128, QR, 2D,
etc.) barcoded labels that can be affixed to the containers of analytical reference substances to identify
them uniquely. Balances with a barcode reader can scan the label and input the identity of the compound
automatically, thus avoiding manual data entry as well as accelerating the process. Other commonly used
samples for weighing can be labeled likewise to avoid manual entry of data. Using bar codes in this way
eliminates another source or error in the process.

2.7 Comparison and Summary of the Three Ways of Working

Table 4 shows a comparison of activities performed in the three processes and the time taken to perform each
one. This illustrates the benefits of process optimization through using either a balance printer or LabX to reduce
errors and ensure data integrity. As can also be seen in Table 4 there are substantial time savings to be achieved
as well. Moving from a purely manual process to one where a thermic printer records the activities results in
a 25% gain in productivity. However, moving from a manual to an electronic process increases productivity
by 194% for each weighing. Even if a laboratory already has a printer, converting to an electronic process with
LabX still brings a productivity gain of 135%.

METTLER TOLEDO Data Integrity Guide 17

 An Example for Weighing What do these figures mean in practice? As weighing on an analytical balance is a very common activity, let
us examine their implications for a relatively small laboratory with a staff of 10 analysts. If each analyst makes
1,000 weighings per year (reference standards, samples, control samples and preparation of buffers and mobile
phases) or between 4 and 5 per working day, then there will be 10,000 weighings per annum throughout the
laboratory. Using the timing figures from Table 4, we can calculate the total time spent on weighing operations
in this laboratory as shown in Table 5. The first row of Table 5 outlines the total time spent on weighing in the
laboratory; it is calculated by multiplying the time for the operation from Table 4, converting this to days and
dividing by 220 days available per year for working in the laboratory. The result of the calculation is expressed
as FTE or Full Time Equivalent. The reason for choosing FTE to present the saving is that any laboratory in any
country can read and understand the time taken and also the potential savings to be gained from improving the
process.

Activity Performed 1. Manual, 2. Manual, 3. Electronic,

no Printer with Printer with LabX
Prepare lab notebook for work • •
Log on via balance screen •
Check balance function and tare vessel • • •
Document check in lab notebook •
Weigh reference standard • • •
Record value in lab notebook (lab journal) •
Remove vessel and tidy balance • • •
Paste printout into lab notebook •
Calculate concentration manually •
Enter values to spreadsheet •
Calculate results in spreadsheet and print •
Paste spreadsheet printout into lab notebook •
Check work and analyst signs lab notebook • •
Second person check of work • •
Correction of any mistakes • •
Second person signs the lab notebook • •
Automatic calculation of results •
Analyst electronically signs the report •
Second person checks the work •
Second person electronically signs the report •
*Overall Time for the Process 25 min. 20 min. 8.5 min.
Note: *Verified in internal lab tests.

Table 4: Comparison of timings for the three processes

1. Manual, 2. Manual, 3. Electronic,

no Printer with Printer with LabX
Total Time Spent on Laboratory Weighing 0.79 FTE 0.63 FTE 0.27 FTE
Saving with changed process (per annum) 0 0.16 FTE 0.52 FTE
Percentage process improvement over Baseline 25%
baseline process Baseline 194%
Baseline 134%

Table 5: Calculated time spent on weighing operations in a laboratory

18 METTLER TOLEDO Data Integrity Guide

As can be seen from Table 5, whilst small productivity improvements can be made with the addition of a printer,
the most productivity gain is achieved when moving to an electronic process. In our example, the electronic
process can save half a person per year continually, compared to the manual process without a printer. These
gains are in addition to the benefit of error reduction that we discussed earlier.

This white paper has deliberately chosen to base productivity and time improvements using a relatively small
laboratory as an example. For larger laboratories with more personnel or where more weighings per analyst are
performed, then the time and productivity savings will be much bigger.

For GxP regulated laboratories, there is always the need to validate the software before use. The cost of
computer validation on the overall cost savings is discussed later.

1. Manual, no Printer but with
Hand-held Calculator
• Transcription of results from balance
screen to lab notebook subject to tran-
scription errors
• No independent check of
balance readings
• Approach not accepted by GxP inspec-
tors as no independent evidence of
weight taken
• Manual transfer to spreadsheet
• Two manual transfers of data
followed by two checks for
transcription errors
• Slowest and most error-prone process
2. Manual, with Printer and
Spreadsheet
• Printout of weighing results and ability to
review data from start to finish
• Elimination of one set of data transcrip-
tion and associated checks
• Improved data integrity
• Validated spreadsheet
• Approach acceptable to GxP
Inspectors
• Faster than process 1; reduced errors
due to printouts
3. Electronic, with LabX and
Electronic Signatures
• Fully electronic process
• Validated software and process
• Automated data capture –
no writing by hand required
• No transcription of data and therefore no
transcription checks required
• Printout of final signed report optional
• Fastest process of the three
examples

Table 6: Comparison of error reduction, quality improvement and data integrity between the three processes

Table 6 compares the error reduction and quality improvement from the manual process to the electronic
process using LabX. One of the key points expressed by the table is a reduction of errors made in the laboratory.
However, this is a subjective statement. What we need to do is compare studies that have looked at error rates
in laboratories. Papers on how often we make mistakes in an analytical laboratory are hard to find. Help is at
hand from clinical chemists working in hospitals who have published many studies on this subject. Clinical
chemistry is involved in the analysis of human blood, urine and tissues to assist diagnosis and management of
diseases. Mistakes in this area can critically impact the health of a patient, so reducing errors is essential.

METTLER TOLEDO Data Integrity Guide 19

 An Example for Weighing • One paper, entitled The Blunder Rate in Clinical Chemistry, measured the rate of detected analytical errors
before and after the introduction of a Laboratory Information Management System (LIMS). This was reduced
from about 5% to less than 0.3% after implementation of the computer system [Ref 7].
• Manual transcription errors in patient blood results recorded in a critical care setting by comparing the hand-
written and printed laboratory results in 100 consecutive patients in the intensive care unit of a UK hospital.
Out of 4664 individual values, 67.6% were complete and accurate, 23.6% were not transcribed at all, and
8.8% were inaccurate transcriptions of the results. Interestingly, this study found that the most accurate work
was performed in the morning [Ref 8].

The first study shows that the overall impact of automating a process results in a 10-fold reduction in input
errors to a LIMS. The second shows that when personnel are under pressure, as in an intensive care facility, then
the error rate increases. Therefore, in a laboratory with a manual process the checking needs to be performed
diligently to ensure that as many errors as possible are caught and corrected.

Therefore taking the principles described above, LabX, an instrument control software application, can be used
to automate weighing process as described earlier and eliminate many data input errors.

2.8 Validation of an Electronic Process

Software used in GxP regulated laboratories must be validated for its intended use. To help, there are guidance
documents available such as the Good Automated Manufacturing Practice (GAMP) version 5 guidelines [Ref
5] and the GAMP Good Practice Guide entitled “A Risk-based Approach to Compliant Laboratory Computerized
Systems” [Ref 6]. However, in regulated laboratories there is often a fear that computer validation is a slow,
laborious, burdensome, paper process.

If a risk-based approach is taken for validation, then these fears should not occur. Validation of LabX can use
a simpler life cycle for configurable software, and most of the testing effort should be focused on the configured
process rather than the basic application. If this is true, then the effort of validating software needs to be put in
context with the daily savings gained by use of the software throughout the laboratory. The principle of “validate
once and use multiple times” holds here.

Furthermore, computer systems validation should be viewed as a benefit rather than a cost. The time saving
with using a validated electronic process far outweighs the one-time cost to validate the application. Therefore,
the time saved increases the period in which personnel can focus on more productive tasks in the laboratory.

An educated estimate of the time to validate the whole of LabX is between 20 and 40 days. However, this time
embraces the whole system inclusive of other processes configured for different instruments and other balance
processes. However, let us assume that LabX is only to be used for weighing reference substances and
preparing solutions as outlined in process 3. Even in the worst case of 40 days to complete the validation of
a single process, this equates to 0.18 FTE. The time saved by using an electronic process as calculated in
Table 5 is 0.27 FTE. This means that in the first year, the laboratory still saves at least 0.09 FTE and 0.27 FTE
per year thereafter. If the computer system validation is quicker and takes less time, then greater savings are
obtained. As noted above, this is a small laboratory; for a larger laboratory the relative savings will be much
bigger, with the same validation costs.

20 METTLER TOLEDO Data Integrity Guide

3. An Example for BRIX Determination

3.1 The Workflow of Smart Standard Preparation

Creating standards and buffers onsite with the accuracy and efficiency of using multiple instruments with one
method or task is one solution made possible with LabX. One example of standard preparation to be used
for calibrating another instrument is creating a brix standard on a balance to calibrate a refractometer. This is
usually done in two distinct workflows, one on the balance and one on the refractometer. LabX allows
connecting both instruments and workflows, speeding up these workflows, increasing the accuracy and
traceability, and eliminating transcription errors.

Soft drink and juice companies calibrate their instruments regularly, in order to verify the accuracy of their
measurement. This is done with Brix standards, which are produced onsite by mixing sugar and water in a
defined proportion. Occasionally, traceable Brix standards are purchased from a certified company in order to
test the instrument with an external certified standard. These standards are expensive and have a limited
shelf life, this is why for the "daily" routine, standards are used which are produced in-house. Being able to
make the standard onsite in a traceable and guided method is a great benefit for such operations.

In this example LabX guides the user through the

different steps of the standard preparation, displaying
clear instructions on the balance screen. It calculates
the exact concentration of the standard from the
actual sample weights and sends this value to the
refractometer as well as printing this data on a
barcoded label to travel with the sample. The user then
goes to the refractometer and follows the instructions
for the calibration using the target value sent by LabX.
Figure 5: from left to right: Barcode printer, analytical balance,
barcode reader, refractometer, LabX software.

3.2 Seamless Workflow from Balance to Refractometer

The user begins the method on the balance touchscreen. LabX user guidance asks to specify the sample
identification and target concentration and then to place the beaker on the balance. After automatic taring the
user guidance steps the user through weighing the required quantity of sucrose into the beaker. Additional
taring takes place and the user is prompted to weigh in the distilled water. The SmartTrac™ display shows the
tolerance and limits in a graphical display (See Fig 6).

Figure 6: Workflow continuing on Refractometer Figure 7: Workflow continuing on Refractometer

METTLER TOLEDO Data Integrity Guide 21

 An Example for BRIX Determination The exact Brix value (sucrose concentration) is calculated automatically by LabX, using the measured weight
of the sucrose in the first step and the weight of the added water in the second step. Once the weighing task
has been completed, instructions for optimum sample preparation are displayed on the balance screen.

After completion of the sample preparation, a barcoded label is automatically printed with detail of the sample
(ID, calculation, expiry data, etc.) to be placed on the vessel. The user transfers the sample to the refractometer
and the task that was started on the balance is waiting at the refractometer touchscreen to be continued by
a simple and secure barcode scan (See Fig 7). The task is continued on the refractometer with the corrected
concentration and the user is once again guided through the process of pipetting a sample of the homo-
geneously mixed sugar standard in the refractometer. Both the nominal value and the actual result are displayed
showing the current performance of the instrument.

This is a truly simple process: Guided step by step from start on the balance to finish on the refractometer. Busy
labs will not have to interrupt and slow down their throughput as this process could remain paused between
creating the standard at the balance and measuring at the refractometer. As this all works on one software the
information is available from various locations to start, pause, and finish the task. The process is even more
simplified and improved by using barcoded samples with an attached bar code reader.

Select a shortcut on the balance The task is resumed by selecting

to start the task that runs the on the list or scanning
defind SOP the sample's barcode

Select the desired concentration The SOP on the display guides

on the balance display the user through the measurement

The SOP on the display guides Results are displayed

the user through weighing sucrose and with specification of the deviation
water from the standard

Instructions for correct homogenization

LabX automatically saves all
are displayed
information and results
on screen

The sample and task are available to be

continued
on the refractometer

Figure 1: Example of a seamless workflow from an balance to an analytical instrument

22 METTLER TOLEDO Data Integrity Guide

3.3 The Benefits of this Workflow over Stand-alone Instruments
Directly connecting laboratory balances and instruments to LIS systems offers significant advantages. However,
implementation suffer often from technical limitations and cost overruns with less than desirable results. LabX
software incorporates the lab balances and analytical instruments to form a single "bench top environment"
at the IT foundation level. Thus, using LabX 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.

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.

By installing LabX software organizations wishing to improve weighing and analytical results, quality
compliance, data integrity, 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.

1) Step by step user guidance for the production of the standard based on • Clear workflow
the user's own SOP • Less mistakes
• Faster weighing
2) SmartTrac precise weighing into specific tolerance range
• More accurate weighing
• No transcription errors
3) Calculation of exact BRIX concentration by LabX
• Time savings
• No transcription errors
4) Transfer of target BRIX value of standard to the refractometer
• Time savings
5) Electronically recorded and stored log of standards produced and tests • Ready for the next audit
performed in LabX

Table 7: Advantages of a LabX guided workflow using a balance and an instrument. Example: Sucrose standard preparation for Brix
determination with automatic refractometer.

METTLER TOLEDO Data Integrity Guide 23

 the balance to the titrator is automated, preventing errors and saving valuable

Titratio time. Even method selection can be automated based on the data stored on
RFID tags.

Weighing titration samples can be time-consuming and error-prone if each

An Example for Titration
4. An Example for Titration
sample weight and ID is entered manually in a journal or on the sample beaker,
and then on the titrator.
4.1 Efficient and Error-free Titration Workflows
The new SmartSample system can improve this workflow by automatically
Manually recording titration sample weight and ID can be a laborious and error-prone task, if each sample
transferring sample data from the balance to the titrator using a RFID tag attached
weight and ID is entered manually in a journal or written on the sample beaker, and then keyed in the titrator
to the titration beaker. Sample ID and weight are stored on the tag, which can be
The new SmartSample system improves this workflow by automatically transferring sample data from the
attached directly to the beaker or to a removable sleeve (figure 1).
balance to the titrator using SmartTag (Fig. 9). SmartTag, an RFID tag, is attached directly to the beaker or to a
removable sleeve and stores sample ID, weight and other sample data.

Sample beaker with Weight and sample Info is written to Sample is automatically analyzed using
RFID tag RFID and XPE balance the data on the RFID on the InMotion
sample changer

Figure 9: The SmartSample workflow

4.2 Automated Data Transfer

Using the RFID option of METTLER TOLEDO XPE analytical balances is the first step of the automated data
transfer. SmartSample allows to edit entry fields to store all required information such as weight, batch number
and product number. Required sample data may be specified by SOPs, regulations or legal requests. ID
numbers can be increased automatically for sequenced samples, e.g. 123; 124; 125, etc. which is another
practical feature of SmartSample.

Figure 10: Sample beaker with SmartTag on Figure 11: The SmartTag can also be carried
the XPE balance. The Smart Tag is attached by a beaker sleeve. The sleeve is removable
on the bottom of the beaker. and reusable. Thus, tags can be saved when
using disposable beakers.

24 METTLER TOLEDO Data Integrity Guide

The second step of the automated data transfer is the reading of the RFID tag by the InMotion™ sample changer.
After the titration is started, all sample data are transferred from the RFID tags on the beakers to the titrator's
memory and taken into account for result calculation and presentation.

The entire sample information only needs to be recorded once and is then transferred automatically and
unambiguously. With no manual data recording nor entry required, valuable time is saved on each sample and
transfer errors are avoided.

4.3 Automatic Method Selection with LabX® SmartCodes

Samples can be placed in any order on the InMotion sample changer with SmartSample keeping sample data
always to the right sample. However, each sample needs a titration method to do the analysis.
Method selection can be fully automated using SmartCodes. SmartCodes is a functionality of LabX laboratory
software that allows a particular titration method to be automatically allocated to a sample. This brings workflow
security and automation to the next level.

Based on data stored on the RFID tag, LabX automatically selects the correct method which is then executed for
the respective sample. In this way,
• the right method is activated always
• any number of samples are accepted without allocating a defined number in advance and
• "unexpected" samples can be measured anytime in between the other samples.
The InMotion autosampler rack can be filled with different samples requiring different methods. The entire set of
samples can analyzed with one click on the titrator's touchscreen.

SmartCodes are defined in LabX software. The editor requests the following entries:
• Name of Smart Code, e.g. Acidity 65
• Sample correlation, e.g. sample ID, product ID, etc
• Method correlation, e.g. method ID (number)

Figure 12: SmartCode editor screen Figure 13: LabX screen showing active
(partial view) SmartCodes

4.3 New Level of Data Integrity

With SmartSample, manual errors due to data transcription and sample mix-ups are prevented. SmartCodes
enables the titrator to identify the correct method and perform the right analysis with no fail. The combination of
both measures provides unprecedented high workflow security. Thus, data integrity reaches a new level.

METTLER TOLEDO Data Integrity Guide 25

 Summary 5. Summary

Directly connecting laboratory balances and instruments to LIS systems offers significant advantages. However,
implementation suffer often from technical limitations and cost overruns with less than desirable results. LabX
software incorporates the lab balances and analytical instruments to form a single "bench top environment"
at the IT foundation level. Thus, using LabX 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.

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.

By installing LabX software organizations wishing to improve weighing and analytical results, quality
compliance, data integrity, 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.

6. References

Reference used in the creation of this guide follow.

[1] FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories (1993), section 13
[2] FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories (1993), section 14
[3] Electronic Records; Electronic Signatures Final Rule, 21 CFR 11
[4] EU Good Manufacturing Practice regulations, Annex 11 computerised systems
[5] Good Automated Manufacturing Practice (GAMP) Guide, Version 5, International Society for
Pharmaceutical Engineering, Tampa, Florida (2005)
[6] GAMP Good Practice Guide, A Risk-based Approach to Compliant Laboratory Computerized Systems,
International Society for Pharmaceutical Engineering, Tampa Florida (2012)
[7] A.M. Chambers, J. Elder and D. StJ. O’Reilly, Annals Clinical Biochemistry, 23 (1986) 470-473
[8] R. Black, P. Woolman and J. Kinsella, Presented at American Society of Anaesthesiologists Annual
Meeting, New Orleans, Louisiana, October 2001
[9] Current Good Manufacturing Practice for Finished Pharmaceutical Products 21 CFR 211.68(b)

26 METTLER TOLEDO Data Integrity Guide

7. Additional Supporting Information

7.1 Webinars

We provide web-based seminars (webinars) on different topics. You can participate in on-demand webinars at
any convenient time and place. Live webinars offer the added benefit of allowing you to ask questions and dis-
cuss points of interest with METTLER-TOLEDO specialists and other participants.
www.mt.com/webinars

7.2 Comprehensive Application Support

Application database
Our searchable application databases contain several hundreds of applications from different industrial
segments. Applications are proven methods with results, detailed method parameters and concluding
evaluations.

UserComs
UserComs are periodicals distributed to customers and other persons interested in practical application
feedback, expert tips, technical information and latest product news.

The information is intended to give customers new ideas on how to solve analytical problems in their own
laboratories. If you have an interesting application that you would like to share with other users, we would be
delighted to publish it in UserCom.

Titration applications www.mt.com/titration_applications

Titration UserCom www.mt.com/anachem-usercom
Thermal analysis applications www.mt.com/ta-applications
Thermal analysis UserCom www.mt.com/ta-usercoms
Moisture analyzer applications www.mt.com/moisture

7.3 Lab Library

The Lab Library is a one-stop portal to access

knowledge resources such as literature, webinars,
product information and much more
www.mt.com/Lab-Library

METTLER TOLEDO Data Integrity Guide 27

Power Your Bench
with LabX® Software

LabX connects METTLER TOLEDO instruments to a single software.

A unique interface means less training and more efficiency.

Tailored set up
Develop and implement SOP compliant application methods ready for
use on the relevant instrument. Define the roles of individual users and
set-up the daily task list.

Smooth, error-free workflow

On the instrument, step by step guidance directs the operator.
All work is ensured to be in accordance with internal SOPs

Full data management

All information is automatically stored in a secure database to
ensure traceability. See, store or print results in a customized
report at any time.

Learn more about LabX

www.mt.com/LabX

www.mt.com
For more information

Mettler-Toledo Group
Laboratory Division
Local contact: www.mt.com/contacts

Subject to technical changes

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