Reference Paper

Management of Weighing Data

From Paper to Digital

Integrated lab: Data is electronically transferred to/from the instruments.

Weighing is often the most important step of an analytical lab procedure, even if it may
not seem like the most exciting step. This is because accurate weighing and error-free data
transfer is absolutely essential for accuracy in subsequent process steps, whether you are
taking aliquots of samples for analysis or are preparing solutions, buffers, high-performance
liquid chromatography (HPLC) mobile phases, or analytical reference solutions.
 3 Ways of Data Management
From Paper to Digital
Reference Paper

In this reference paper, we will look at both manual transcription and three
potential solutions for improving the accuracy and ease of data transfer and
management, assessing the strengths and weaknesses of each. As such, this
paper may be particularly interesting for labs that are still largely reliant on
handwritten results or which use manual processing, including keyboard
entry, at any stage of data notation, storage or analysis.

Data quality and integrity. paper or a note-taking application

sive care unit (ICU) of a Glasgow
Using real-world examples, we will on a smartphone or laptop. But Royal Infirmary, Glasgow, UK.
explore how systematically relying have you ever written down a phone
Researchers looked at 954 results
on our powers to remember and number then dialed it later, only
sets that included 4664 value sets.
transmit data can generate signifi- to discover it was wrong? Whether
Complete, accurate transcription
cant errors, even when we are cer- you copied it down wrong or some-
occurred in only 67.6% of cases.
Storage Reporting
Further Analysis /
Data Transfer,
Measurement

tain of our accuracy. Manual data one recited it to you incorrectly, hu-
In 23.6% of cases, data sets were
Data transfer,
Resample

Weighing
Sample /

transcription and report creation mans are known to make mistakes missing. 8.8% of cases had tran-
Export
Import

are also time-consuming and keep when it comes to numbers. scription errors. The study also
laboratory analysts from focusing showed that transcription was
on value-added lab work. Other more scientific analyses show more accurate in the morning,
that people make errors every day pointing to the fact that operator
In short, it is no longer enough with all kinds of data—when typing, fatigue can also affect accuracy
to say, “But that’s the way we’ve when trying to remember words, later in a work shift.
Further
Data
always done it.” It is essential thatWeighing Data
when attempting to read signs and [Reference 1]
Sample / Analysis /
any method Transfer,
chosen to gather, Measure-
trans- charts, and Transfer,
more. And people make
Receipe Storage
mit, and analyzeImport
data ensures datamentthese errorsExport
in situations where
ReportingLet us reiterate that this was in
quality as well as data integrity. they know a­ ccuracy is critical and an ICU: a place where poor data
they are convinced of their own capture can not only affect health
Why are data quality and integrity ­accuracy. outcomes, but could in extreme
so important? cases result in a patient’s death.
The majority of data that we take Take, for example, a case of a These data sets were also created
down in our day-to-day living study of blood records for 100 by dedicated medical profession-
is manual, either using a pen and consecutive patients in the inten- als. Because of this, the number

Further
Data Weighing Data
Sample / Analysis /
Transfer, Measure- Transfer,
Recipe Storage
Import ment Export
Reporting

Figure 1: Laboratory processes —data acquisition, generation and transfer.

2 METTLER TOLEDO Reference Paper

 Data defined

Data quality – ensuring data is generated without errors through use of proper, calibrated equipment, following
SOPs, identifying and training users, and using the right materials. Systems should be designed in a way that
encourages compliance with the principles of data integrity.

Data integrity – ensuring data is transcribed without errors and cannot be manipulated through proper
­set-up of data flow, integration of data and metadata, proper archiving, and ensuring accessibility.
Good Manufacturing Practice (GMP) defines data integrity through the acronym ALCOA, which stands
for attributable, legible, contemporaneous, original, and accurate. The original ALCOA principles have
since been improved to ALCOA+. The original principles remain with four additions: Complete, consis-
tent, enduring and available. Following the ALCOA+ principles is the best way to achieve data integrity.

Metadata – data that provides information about other data, considered attributes of the measured values
(e.g. sample identification, date, time, study number) and technical properties (e.g. instrument, calibration
history, SOP, method version, etc.).

Audit trail – ensures traceability of electronic data. An audit trail is a complete historical record of who did
what, when and why. Computer system design should always provide for the retention of full audit trails to
show all changes made to the data without obscuring the original data. It should be possible to associate all
data changes with the persons who made those changes, for example, by use of timed and dated (electronic)
signatures. Reason for changes should be given.

Further definitions: See References [3] and [4]

of incorrect or incomplete results These examples—situations where down weighing data manually
made a strong case for comput- errors had the potential to directly in a lab notebook or paper form.
erized data capture and records impact quality either on direct care This is because, while weighing can
maintenance. or via research results—mirror our appear to be a simple procedure,
personal experience. And it is no we know that even the everyday act
Another study looked at errors different when writing down weigh- of writing down a phone number
in clinical research. Results from ing results in a lab journal or keying contains significant error potential.
a single unnamed academic center them into a computer. Do you want
were analyzed to assess frequency, to subject your results to this kind
distribution, and features of data- of error potential—particularly in
entry errors to determine if these processes where errors expand ex-
errors were large enough to skew ponentially as additional analytical
results. Errors detected by double- actions are performed downstream?
entry ranged from 2.3% to 26.9% We suspect the answer is no.
and were attributed to both data
entry error and misinterpretation As scientists, engineers, operators,
of original information. and researchers, we must seek
[Reference 2] out better solutions than writing

METTLER TOLEDO Reference Paper 3

 Data Management Option 1:
Add a Printer
Reference Paper

One basic way to eliminate a certain amount of transcription error risk is to

simply add print-out capabilities to your balance, scale, or other analytical
instrument. This is a simple way to document and store data.

Data flow in many labs that use 3. In certain situations, reports Traceability ensured ( )
printers looks like this: are double-checked for errors
and perhaps a few results are Low risk of transcription errors

1. Results generated by analytical recalculated to check if they are

instruments are printed plausible. Some records also
Efficiency of weighing process (( ))
on paper. Some limited meta- require checking by a second Transfer of metadata ( )
data, as ong as it is maintained ­person—the “4 eyes principle”.
in the instrument, can be added Paperless lab
to the print-out. 4. Data may also be manually
Audit trail (system and data)
transcribed into the lab informa- ( )
2. Printed records are then used tion management system (LIMS) Centralized data storage
to manually transcribe figures or enterprise resource planning ( )
Electronic signatures
into reports using programs (ERP) system. ( )
such as Excel. Data integrity
( )
( )

Balance Paper notebook Report

Sample Printer

Approval

ERP / LIMS

Automatic sample data transfer Manual weighing data transfer

Figure 2: Data flow in a lab with weighing results documentation and storage on a print-out, eliminating one source of transcription error.
However, further data processing with manual copy / paste retains the risk of making transcription errors and losing metadata.

4 METTLER TOLEDO Reference Paper

 Digital sample identification

Data quality and integrity can be improved by automated sample identification, e.g. by connecting
a barcode or RFID reader. Sample ID data — as part of measurement metadata — can be printed on strips
or labels, or stored on a sample RFID tag. This allows it to be transferred electronically to the next analysis
step to help eliminate sample mix-ups. Automatic matching of samples and results also saves time.

• Barcode reader (read only), for sample identification and transfer to the balance
• RFID reader (read and write), for sample identification, transfer to the balance, storage and transfer
of measurement results

As you can see, printing results Pros: Direct printing is a simple way
eliminates the error inherent when to document and store measurement
we read and note results off a ter- data without transcription errors.
minal screen. However, this is still
a manually intensive process Cons: The information is not
that requires a significant amount ready for digital processing and
of time and attention, leaving the analyzing. Manual transcription
process open to error. is still necessary.

Data import Weigh Transfer Titrate Export Data

• Paper Secure and efficient No mix-ups Simple and secure • Live Display
• Barcode data input No matter where you analysis • Printer
• LIMS Eliminate transcription put your sample, all All sample information • USB Stick
errors associated with ­information stays on on the tag is automat­ • Network
data input—all sample the SmartTag avoiding ically transferred to • Computer
information together mix-up errors through- your Excellence titrator
with the weight are wire- out your workflow. for simple and secure
lessly transferred to the analysis.
chip (SmartTag) on the
titration beaker.

Figure 3: The SmartSample™ weighing system for titration automation increases sample identification and efficiency with RFID technology.
RFID tags attached to the beakers transfer sample information wirelessly from the balance to the titrator — errors due to data transcription
and mix-ups on the sample rack are eliminated.

METTLER TOLEDO Reference Paper 5

 Data Management Option 2:
Use EasyDirect™ Balance Software
Reference Paper

To eliminate manual steps and related transcription errors, METTLER TOLEDO

Advanced or Standard Level balances can be connected via EasyDirect Balance
software. This allows weighing results to be collected, stored and processed
electronically.

Connect up to 10 balances via Weighing results can be reviewed Traceability ensured ( )

Ethernet, USB-C or RS232 to on the PC screen, filtered by date,
EasyDirect Balance PC software instrument, user or sample. Results Low risk of transcription errors

and improve the management and can be visualized in charts to e.g. Efficiency of weighing process
handling of your weighing data. assess target and tolerance ranges. ( )
Transfer of metadata (( ))
With METTLER TOLEDO’s EasyDirect Meaningful reports can be cre-
Balance software, you can col- ated for documentation purposes: Paperless lab ( )
lect weighing data automatically. Export data from the SQL database
Audit trail (system and data)
Depending on the connected bal- in various formats (XML, CSV,
ance more or less metadata can be XLSX or PDF) to a PC or print them Centralized data storage
included, e.g. value with unit, time on a network printer. ( )
Electronic signatures
and date, sample ID (if entered into ( )
the balance), net / gross, tare, and Data integrity
user name. ( )
( )

Balance Computer Report

Sample

Approval
Barcode
reader Printer ERP / LIMS

Automatic sample data transfer Electronic weighing data transfer Collect and analyze results Export results and report

Figure 4: With EasyDirect Balance PC software, weighing data is collected automatically. Transcription errors are eliminated and data quality
is improved. Easily and efficiently create reports, export data, visualize results in control charts, perform statistics and have a clear overview
about the status of your balances.

6 METTLER TOLEDO Reference Paper

Figure 5: Transfer results from a MA analytical balance to a computer with EasyDirect balance software to eliminate transcription errors and
improve data management.

The connection of an optional and date, sample / task IDs and traceability. This lack of an audit
barcode reader to the balance more. For weighing, net, gross and trail —essentially, not being able
eliminates an additional error tare are also recorded. Results can to determine who changed what,
source by automatically transfer- be visualized on the PC screen or when —potentially reduces data
ring sample IDs as part of mea- printed in informative reports. accuracy and integrity. There is
surement-result metadata. no centralized instrument control.
Cons: There is no centralized data
Pros: Direct transfer from the bal- storage and no API functionality for
ance to a computer eliminates seamless integration to data man-
manual transcription. Adding a agement systems (e.g. LIMS, ELN,
data management software like …). Not all metadata is captured,
EasyDirect balance allows transfer and values can still be changed
of the value along with unit, time or omitted when reporting without

Figure 6: Up to 10 Advanced or Standard level balances, such as MX Balances, can be connected

to the EasyDirect Balance software to collect, store and process weighing results in an elec-
tronic form.

METTLER TOLEDO Reference Paper 7

 Data Management Option 3:
Integrate Into a Network
Reference Paper

Instrument control software such as METTLER TOLEDO’s LabX® offers more

than data capture and data management. Users are fully guided through the
complete workflow according to the SOP, data including metadata is stored
centrally and all steps are fully tracked. In this way, the accuracy of results
is highly improved and traceability is assured back to the origin of data.

1. The sample information is dis- 3. Reports are generated automati- Traceability ensured
played automatically on the cally and all results can be
Low risk of transcription errors
balance screen. approved by the lab manager. ( )
Efficiency of weighing process
2. The analyst weighs the sample 4. All data is stored securely in the
( )
Transfer of metadata
according the directions given database and can optionally be ( )
on the screen. Results includ- transferred to ERP or LIMS Paperless lab
ing metadata are sent seam- systems.
( )
Audit trail (system and data)
lessly to the central database. ( )
All user activities are logged Centralized data storage

by the system.
( )
Electronic signatures
( )
Data integrity
( )
( )
Lab Clients Network Server

• Report
• Storage
• Approval

Sample ERP / LIMS

Figure 7: Data flow in a digital lab with automated transfer of data from the balance to the network server.

8 METTLER TOLEDO Reference Paper

Figure 8: LabX software integrates data capture for many laboratory instruments. LabX works behind the scenes to take care of all your data
while you concentrate on your analyses.

When considering true data in- cesses and calculations are guided, in due course in error reduction,
tegrity, particularly in regulated ensuring each user is guided through time saved, and traceability (which
environments or for high-risk ap- the same analytical process, helping eases both internal and external
plications, full integration of lab to eliminate rework and waste. Meta- audits). This is particularly true for
equipment into instrument control data is linked to results, supporting high-volume or high-risk labs.
software is highly desirable. How- full traceability. A variety of import /
ever, whether it is used in its com- export options allow transfer of data
plete system format or as individual into existing networks, data archives,
methods and data modules, LabX LIMS, ERP and other knowledge-
also provides a robust solution for management systems.
non-regulated labs where accuracy
and ease of use are desired. Cons: Complete solutions such as
LabX tend to cost more than either
Pros: Data can be automatically paper records or simple data transfer
transferred to eliminate transcription solutions at the outset. However,
errors and increase productivity. Pro- initial expense is usually made up

METTLER TOLEDO Reference Paper 9

 Digitalisation of Weighing Data
Reduces Error Risks
Reference Paper

As shown, humans are capable of error, even when stakes are high and
accuracy is desired. While paper logs have historically been the norm,
some level of automating results capture and storage is desirable to
help reduce error risk.

There are essentially three levels of to a PC, or provide full integration implementation of simplified, self-
non-manual data capture that labs with a workflow and data manage- documenting processes, can further
can take advantage of today. While ment system such as LabX, captur- eliminate transcription errors and
there is not a “right” or “wrong” ing data at the point of origin is the avoid unnecessary data retyping.
way to capture data, each level of- foundation of any effort to enhance It can also help ensure metadata is
fers a certain level of security, error data accuracy and integrity. Cap- captured in a structured way so that
mitigation, and time savings not af- ture at this point —without manual it has meaning for future analysis
forded by a primarily handwritten, transcription —helps to eliminate and audits.
paper-based system. Whether you errors.Heightened levels of automa-
choose to add a printer, connect tion in data capture, including the

Management Traditional: Option 1: Option 2: Option 3:

of weighing data Data recording Data output Data transfer, Data integration,
by observation peer-to-peer, client-server,
decentralized centralized

Gateway Eyes, pen Printer, RFID Computer Network, software

such as LabX®

Traceability ensured ( ) ( ) ( )
Low risk of transcription errors
( )
Efficiency of weighing process
( ) (( )) ( ) ( )
Transfer of metadata
( ) ( ) (( )) ( )
Paperless lab
( ) ( ) ( )
Audit trail (system and data)
( ) ( ) ( )
Centralized data storage
( ) ( ) ( ) ( )
Electronic signatures
( ) ( ) ( ) ( )
Data integrity
( ) ( ) ( ) ( )
Table 1: Comparison of three levels of data management to the traditional process of manual ording and transcription.
( ) : Only partially possible or only reachable with extra(effort.
) ( ) ( ) ( )

10 METTLER TOLEDO Reference Paper

References

1. Black R., Woolman P. and Kinsella J., Variation in the transcription of laboratory data in an intensive care
unit, Anaesthesia, 2004, 59, pages 767-769
http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2044.2004.03834.x/pdf

2. Goldberg Saveli I., Niemierko Andrzej, Turchin Alexander, Analysis of Data Errors in Clinical Research
Databases, AMIA 2008 Symposium Proceedings Page – 242
http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.668.8354&rep=rep1&type=pdf

3. MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/412735/Data_integrity_
definitions_and_guidance_v2.pdf

4. WHO Good Data & Records Management Practice, June 2016

http://www.who.int/medicines/publications/pharmprep/WHO_TRS_996_annex05.pdf

Further reading

1. Guide: “How to Achieve Data Integrity in the Laboratory”

www.mt.com/lab-data-integrity

2. Webinar: “The Importance of Data Integrity in a GXP Regulated Laboratory”

www.mt.com/lab-data-webinar

3. White paper, “The Unknown Sources of Error in the Weighing Process”

www.mt.com/lab-accurate-analytical-weighing

4. White paper: “Power the Bench – an Enhanced Strategy for Data Integrity”
www.mt.com/lab-data-integrity-wp

5. Data Integrity Guide: “Secure Your Measuring Processes with LabX Software”
www.mt.com/qc-security

METTLER TOLEDO Reference Paper 11

 METTLER TOLEDO Product Information

LabX® software:
Reference Paper

www.mt.com/labx

EasyDirect Balance software:

www.mt.com/EasyDirectBalance

Printers:
www.mt.com/lab-printers

Lab Weighing:
www.mt.com/balances

Laboratory accessories:
www.mt.com/lab-accessories

METTLER TOLEDO Group

Laboratory Weighing
www.mt.com
For more information
Local contact: www.mt.com/contacts

Subject to technical changes.

© 03/2024 METTLER TOLEDO. All rights reserved.
30364193B
Group MarCom RITM1159236 RK/KR/NM