The Paperless Lab - Vialis

The Paperless Lab
Andreas Schild and Dr. Ulf Fuchslueger
Vialis AG, Liestal, Switzerland
Pharm. Ind. 73, Nr. 12, 1 – 4 (2011)
© ECV • Editio Cantor Verlag, Aulendorf (Germany)
Arzneimittelwesen • Gesundheitspolitik • Industrie und Gesellschaft
Fachthemen
Laboratories working in the pharmaceutical industry in the areas of
R&D and quality control find themselves increasingly having to cope
with conflicting demands – tougher regulatory requirements and
harsher economic realities. In order to meet these demands, new
ways of dealing with process-, data- and system management are
necessary. This article shows how the paperless lab (as an integrated
process, not as a system implementation) can meet these challenges
and boost efficiency.
Why new concepts for
laboratory data management?
Laboratories working in the pharmaceutical
industry in the areas of
R&D and quality control find themselves
increasingly having to cope
with conflicting demands – tougher
regulatory requirements and harsher
economic realities. On the one hand,
the authorities require more data
with more quality, such as with the
new EU GMP Annex 11 and the more
intensive FDA inspections regarding
21 CFR Part 11. On the other hand,
there are the commercial pressures
requiring more data in less time,
typically with the same level of staff
or less. On top of that, advances in
technology and laboratory equipment
mean that ever more data is being
generated faster – which creates
almost insurmountable obstacles for
conventional documentation- and
data-management processes in regulated
laboratories, in turn causing
bottlenecks for the development and
approval processes.
The root of all evil: hybrid
systems
When you look at data management
in the lab, what you usually see is a
mixture of various independent, nonintegrated
data-processing systems
on paper and in electronic form.
Often paper is the preferred documentation
medium when you have
a mix of countless computerized
systems such as analyzers, office applications
and upper-level systems,
for example, laboratory-information
management or enterprise-resourceplanning
(ERP) systems. Such a scenario
results in producing a hybrid
system with numerous media gaps
– this is the real root of all evil, leading
to inefficiencies, quality and compliance
risks and unnecessarily long
throughput times which prevent
businesses from hitting their targets.
Table 1 shows the typical key performance
indicators of such a laboratory.
The high level of quality risk (due
to the high number of manual data
transcription steps) is countered
with extensive control steps – but
that results in less efficiency and
longer throughput times. The use of
isolated systems prevents the timely
transfer of information, which leads
to further unforeseeable delays and
additional costs.
And last, but not least, it can result
in a considerable amount of the
enterprise’s intellectual capital being
wasted. The cost of using various isolated
systems to collect data for modern
knowledge-management systems
(statistics, data mining, reporting, exception
handling, etc) is simply too
high. So much knowledge that could
be extracted from the data collected
remains untapped.
In the industry, there are three different
approaches to addressing this
root problem. The first – and actually
no real solution – is the optimization
of the existing hybrid system
by adapting the existing processes
and systems. It goes without saying
that such an approach only brings
selective and slight improvements.
The second is the introduction of
electronic documentation systems
(often described as electronic lab
notebooks) that show the paper data
in electronic format. While the introduction
of such a system brings
certain benefits for quality and compliance
purposes, the real problem is
simply transferred from paper to an
electronic format (“paper on glass”)
■■Table 1
English reprint of the
German original publication
Typical key performance indicators
(KPI) for quality control and
development laboratories.
KPI Value
Effort documentation 45 %
and control
Number of quality- 100
relevant transfers
(per approved batch)
Number of redundant 250
data transfers
Process time up to 20 days
Systems in operation 10
(paper and electronic)
With the exception of the documentation and
control effort, all numbers refer to the approval or
analysis of one batch. Quality-relevant transfers
have a direct impact on the result; redundant data
transfers provide references and cross-references.
Schild and Fuchslueger • The Paperless Lab 1
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lFor use with permission of the publisher l
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Fachthemen
and the hoped for gains in efficiency
are only very small. And the practicality
of introducing electronic documentation
into the laboratory (using
tablet-PCs or other mobile devices)
is highly questionable. The third approach,
which we discuss in more
detail below, is the optimization and
simultaneous electronic support of
the actual laboratory processes – the
introduction of the paperless lab.
The way to a paperless
laboratory
Since introducing a paperless laboratory
involves more than simply implementing
another IT application,
the procedure model we use here
takes into account other perspectives
in order to build a sustainable
overall concept. These perspectives
fall into three main areas – the business
needs, the user’s needs and the
technical perspective.
The business point of view defines
the project’s goals and vision and
ensures that the introduction of the
paperless laboratory complements
the company’s overall business objectives.
Typical goals for producers
are increasing net cash flow, reducing
development time and thereby
generating additional sales or reducing
warehousing and stock costs
to free up more capital. Naturally,
various other goals or combinations
of targets are possible – but what is
decisive is that a quantitative connection
can be made between laboratory
activities and business objectives.
This is achieved by defining a
business-specific cause-effect model
and implementing it into a corresponding
financial model [1]. That is
the only way that you can ensure that
the implementation project meets
the company’s targets and that the
cost-benefit analysis accounts for all
relevant factors.
The user’s point of view is the
central element to developing the
paperless laboratory concept. Based
on a thorough process- and system
analysis, the user’s perspective will
be summarized in the form of process
descriptions and data-streams.
Apart from the actual laboratory pro-
2 Schild and Fuchslueger • The Paperless Lab
cedures – such as sample flow and
processing – supporting processes
will also be mapped (such as apparatus
maintenance, reference substance
management and reagents in
actual state). For every process step,
information will be collected from
any systems used, any responsibility
changes and any data inputting and
outputting. Key performance indicators
will be collected from the process
analysis for later integration into
the financial model. Vital interfaces
with upper-level processes will be analyzed
and documented. The analysis
process is also the foundation for the
subsequently conducted multi-moment
analysis – a methodology that
allows quantitative information to be
derived from and for processes.
Multi-moment analysis [2, 3] provides
statistically sound and accurate
information about the use of resources
per process step or sub-step – and
for all processes. To collect data,
every laboratory worker is equipped
with a mobile device or PDA (configured
for their particular tasks) that
requires them periodically, but randomly
(on average every 20 minutes)
to select the task they are currently
performing from a list. The impact of
multi-moment analysis on the workflow
is minimal because just a simple
click suffices – no recording of times
or other parameters is required. Over
a typical period of two weeks, sufficient
data is collected to enable
highly detailed statistic analyses to
■■Figure 1
be made on costs, time and clustering
for processes, process steps and
task categories. Figs. 1 – 3 show examples
of various evaluations from
a multi-moment analysis. The multimoment
analysis not only allows
processes (independent of whether
a new system is introduced or not)
to be optimized where the greatest
need or benefit lies, but also permits
the work stages to be categorized –
thereby enabling a quantitative assessment
of the potential benefits
that the implementation of a paperless
lab would bring (see Fig. 3). That,
in turn, provides the foundation for a
fact-based business case and for the
comparison of various implementation
scenarios and their economic
benefits. The qualitative process description
(together with the key performance
indicators and quantitative
statements from the multi-moment
analysis) thus provides the crucial
information for the paperless laboratory
concept development.
Taking the technological (i. e. IT
and equipment) point of view – and
looking at the existing infrastructure,
company standards and long-term
strategy – enables a comprehensive
concept to be developed for the automation
of the laboratory data-flow
process. Only then will such a concept
be in line with the company’s
commercial targets.
To develop the paperless lab concept
– as well as considering the
three perspectives outlined above –
Distribution of tasks for a specific laboratory process as a percentage of work hours.
The colors display the categorization in 4 categories; the documentation and control
categories could be substantially reduced by the introduction of a paperless laboratory.
Pharm. Ind. 73, Nr. 12, 1 – 4 (2011)
© ECV • Editio Cantor Verlag, Aulendorf (Germany)

■■Figure 2
Distribution of non-process activities per department as a percentage of work hours.
■■Figure 3
Aggregate values for all process and non-process activities for five different categories
per department and as a total amount. The documentation and control categories
show the potential of the introduction of a paperless laboratory.
you also need a set of principles that
allow for a definition of process targets
based on the process description
of the actual-state processes.
The key principle and the vision of
the paperless lab is the self-documenting
process – a process that
produces GxP-compliant documentation
and eliminates unnecessary
tasks from the workflow. That naturally
means that manual data collection
and transfer are eliminated
wherever possible by interfacing to
and from devices and systems – and
where that is not feasible, by using
barcodes for fast, error-free data
collection. That also means that
redundant or fragmented data is
eliminated, that the “single-sourceof-truth”
principle is implemented
and that data is available to every
authorized user in real-time. That,
in turn, leads to improved process-
es, faster decision-making and better
teamwork.
The application of these principles
to the actual-state processes enables
target-processes to be defined and
functional requirements to be established.
As part of the paperless lab
concept, the delta between the current
functionality and the required
functionality will be generated in the
gap-analysis. This is the only way the
filling of such gaps may be conceptually
approached – naturally always
considering the underlying business
targets. Possible scenarios also include
the modification of existing
IT systems by adapting existing applications
to close functional gaps
and multiple scenarios to close the
remaining gaps with other applications.
Once the only kind of application
specifically aimed at laboratory
use was a laboratory-information-
management system (LIMS), but
today there are many types of applications
providing overlapping functionality.
For example, electronic laboratory
journals (ELN), sometimes
for quality control referred to as laboratory
execution systems or LES (derived
from manufacturing execution
systems or MES); archiving or rawdata
management systems (scientific
data management system or SDMS);
specialized applications for device
and system integration, increasingly
also software that was not originally
laboratory-specific, such as productlifecycle-management
(PLM) systems
or ERP systems. Some software
firms also offer combinations of the
above-named applications and there
is generally a trend towards an extension
and overlapping of functions
or convergence of applications.
There is no quick answer as to which
application combination is the best
for a company. But by using SWOT
analysis (strengths, weaknesses, opportunities
and threats) to compare
the various possible combinations
– naturally accounting for the overall
business targets and not just the
needs of the laboratory – the selection
can be reduced to one or two
scenarios.
The next step is to select suitable
products to fit the desired application
combination for the developed
scenario. With a sound concept, defined
target processes and their functional
requirements, that is a relatively
easy undertaking. As well as the
functional considerations, it is also
necessary to consider the complexity
of the IT landscape and soft factors,
such as the readiness of the software
suppliers to cooperate.
Before making any final selection
– and to clear up any technical issues
and to get prospective users involved
at an early stage – it is recommended
piloting the whole solution in small,
well defined stages. Such a pilot
scheme – which costs little in terms
of money and risk – should cover as
many areas of the paperless laboratory
as possible and helps fine-tune
the final implementation planning.
The implementation of the final solution
is made in accordance with
Pharm. Ind. 73, Nr. 12, 1 – 4 (2011)
© ECV • Editio Cantor Verlag, Aulendorf (Germany) Schild and Fuchslueger • The Paperless Lab 3
lFor use with permission of the publisher l

lFor use with permission of the publisher l
Arzneimittelwesen • Gesundheitspolitik • Industrie und Gesellschaft
Fachthemen
widely accepted standards, such as
GAMP ® [4]. Because the pharmaceutical
industry is so highly regulated,
the whole system must be validated
to meet strict requirements [5, 6]. The
work invested in the procedure model
(e. g. process analysis, concept development,
setting target processes and
piloting) pays off here, contributing
towards the necessary documentation.
It should not be forgotten at this
point that the paperless laboratory is
not just the introduction of a system,
but is also – above all else – process
re-engineering. It is therefore necessary
to support the new optimized
process landscape with all necessary
standard operating procedures
(SOPs) and guidelines to maximize
the benefits of the paperless laboratory.
Faster, more precise
and more economic
Because of its integrated and process-oriented
approach, the benefits
of the paperless laboratory compared
to using a specific application
(such as an ELN) are several factors
higher. The automation of the data
flow and the continued elimination
of documenting and related control
activities significantly boost efficiency
for laboratory staff and management.
Already through these effects
4 Schild and Fuchslueger • The Paperless Lab
alone, efficiency gains of 20 – 30 % are
feasible (depending on a company’s
situation). Additionally, the virtual
elimination of manual tasks substantially
reduces processing times
and quality risk. System-specific automatic
checks ensure compliance
and data consistency reduce control
activities to atypical results (“review
by exception”), thereby accelerating
processes and improving resource
allocation. Since automatic documentation
also automatically generates
numerous process-relevant
parameters – such as throughput
times for certain tasks, equipment
utilization or sample logistics – there
is an excellent source of data for laboratory
management. The paperless
laboratory delivers key performance
indicators for its own continual
improvement, free of charge – and
enables the comparison of organizational
units using high quality
data. And the availability of real-time
data benefits other areas outside the
laboratory – by simplifying interdepartmental
cooperation, supporting
knowledge management and improving
follow-up processes. From
the users’ point of view, the paperless
lab substantially simplifies the workflow
and reduces the number of systems
implemented. It also supports
user-specific portals and sharpens
focus on what is important.
It is clear that the sum of the paperless
lab’s benefits is enormous. As
with all investment projects of this
size, after implementation, evidence
should be presented to show that the
estimated business case and reality
correspond. This can be done at any
time with the help of multi-moment
analysis, which can also be used to
quantify the impact of any process
change on the workflow.
■■ REFERENCES
[1] Ritter J. Reducing Cost by Automating
Laboratory Workflow. G.I.T. Laboratory
Journal. 2009;13(7 – 8):32 – 34.
[2] Haller-Wedel E. Das Multimomentverfahren
in Theorie und Praxis. Munich
(Germany): Carl Hanser Verlag; 1969.
[3] Simons B. Das Multimomentzeitverfahren,
Grundlagen und Anwendung. Kologne
(Germany): Verlag TÜV Rheinland
GmbH; 1987.
[4] ISPE: GAMP ® 5, a risk-based approach for
GxP compliant computer systems; 2008.
[5] Food and Drug Administration: 21 CFR
Part 11.
[6] EU-GMP Annex 11.
Correspondence:
Andreas Schild,
Vialis AG,
Kesselweg 40,
4410 Liestal (Switzerland),
e-mail: andreas.schild@vialis.ch
Editor-in-chief: Claudius Arndt. Secretary’s office: Gudrun Geppert. Publisher: ECV ·Editio Cantor Verlag für Medizin und Naturwissenschaften GmbH, Baendelstockweg
20, 88326 Aulendorf (Gemany). Phone: +49 (0) 75 25 94 00, Fax: +49 (0) 75 25 94 01 80. e-mail: redaktion@ecv.de. http://www.ecv.de. Production: stm media GmbH /
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Pharm. Ind. 73, Nr. 12, 1 – 4 (2011)
© ECV • Editio Cantor Verlag, Aulendorf (Germany)