The document discusses strategic consulting services from PEPR Consulting to help life science companies increase productivity and efficiency in their lab operations through a seven-step program. This includes an analysis of current processes and systems, a Multi Moment Analysis to identify inefficient tasks, development of optimized future processes and systems requirements, creation of a business case, and support in selecting and deploying new lab informatics solutions. The consulting aims to realize improvements of up to 30% for clients.
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Do you have the following challenges?
• Do you need to increase productivity and effectiveness of your lab operations?
• Do you want to reduce time to market and boost collaboration ?
• Are you concerned about data quality / data integrity issues?
• Do you need to replace your lab informatics systems and feel overwhelmed by the
complexity of the market?
• Do you need to align consistent processes throughout the organisation?
Introduction
PEPR (PErfect PRocess) - Consulting
Filling the void of truly independent, strategic consulting for the Life Science Industry
Let us help you achieve your goals:
With our success-proven seven-step program we have realized up to 30% efficiency
improvements for major European Life Science companies lab operations.
We are lab-experienced chemists with a solid background in business administration and
management, a passion for sustainable process improvements and in-depth knowledge of lab
informatics. Originating from the renowned "Vialis paperless lab solutions" team, PEPR-
Consulting continues its tradition of successful strategic management consulting for the life
science industry.
Our strengths are the deep understanding of your lab processes, current GxP requirements
and a broad and independent knowledge of lab informatics solutions available today and the
trends shaping the future lab environment.
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We can help you achieving your goals
Meet our experienced team for a first informal discussion. We are very interested to listen to your
needs and pain-points and are happy to present our success-proven program to your
organisation and propose solutions for building highly efficient and compliant self-documenting
processes.
We are associated with wega Informatik AG who complements our knowledge with in-depth
savoir-faire in lab & research IT, CSV & QA, clinical development and IT solutions deployment.
Introduction
Stephan Gürtler
Chemist Dipl-Ing. FH, MBA
Rochester-Bern
Stephan has over 20 years
experience in quality, regulatory
and laboratory management
within food-, pharma- and
chemical Industries.
He worked as a senior
management consultant within
Vialis AG and later Accelrys and
Dassault Systèmes BIOVIA where
he was responsible for conceptual
planning and implementation of
global paperless solutions for drug
product development and quality
control.
Andreas Schild
Chemist Dipl-Ing. FH, MBA
Innovation Management, Bern
Andreas looks back on over 15
years of experience in the
pharmaceutical industry as
manager, project leader and senior
consultant.
He led the management
consultant team with Vialis AG and
its successors. Together with his
team, he developed the current
consulting methodology and
specifically the Multi Moment
Analysis as a modern digital
method for measuring process
efficiency.
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„Coming together is a beginning; keeping together is
progress; working together is success.”
Henry Ford
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Seven steps on your way to success
Roadmap to success
With our success-proven seven-step program we will guide you through a sound as-is
situation analysis and facilitate your change to a 20-30% higher performance with better
automated and integrated work processes. We will support you in optimizing existing
assets, selecting optimal additional solutions and support your business case for justifying
its funding. We are the right partner to design your future lab operations.
Situation
Analysis
Solution
Finding
Value realisation
Strategic Consulting
1 2 3 4 5 6 7
Process &
Systems
Analysis
Multi
Moment
Analysis
Concept
Future
State and
Roadmap
Business
Case
Solution
Selection
Support
Solution
Deployment
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As-Is Process and Systems
Analysis
The first step is a sound as-is process and systems
analysis, being the stepping stone for a successful
improvement project. Our senior consultants are lab-
experienced experts in regulated environments, practised
and trained to ask the relevant questions.
On-site interviews with your process and system experts
serve multiple purposes: mutual understanding of the as-
is situation, identification of the challenges and pain points
and first improvement ideas from the local subject matter
experts.
A thorough and detailed documentation serves as the
knowledge base for all further steps.
Pain points and available KPI’s are assessed and
documented as a baseline for the improvement potential.
As part of this situation assessment we will analyse your
current system landscape as well as your current mid- to
long term IT strategy.
Value Proposition
Value generated:
• Thorough understanding of current processes and
needs
• In-depth documentation, also as a basis for later
process improvement
• Layout and analysis of current system architecture
• First metrics as baseline for improvement potential
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Process Analysis
During process analysis our senior
consultants will interview your
process owners and capture all
process flows at the relevant level of
detail.
A thorough and detailed process
documentation will be compiled,
serving multiple purposes:
knowledge base, improvement
baseline and requirements source.
System Analysis
Together with your IT-experts we
will draw an outline of your existing
system landscape and collect
information about its current
performance. We will also look at
current implementation projects and
consider your mid- to long term IT
strategy.
As-Is Process and Systems Analysis
Value Proposition
Metrics
As part of the as-is situation
assessment, a baseline of available
current KPI’s will be documented.
Additionally, we will also identify and
capture recurring pain points and
”quick win” optimisation potential.
Deliverables
• Process diagrams
• Detailed task descriptions
• Categorisation of information and
systems
Deliverables
• System landscape description
• IT strategy
Deliverables
• Identification of pain points
• Key performance Indicators
• “Quick win” potential
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Multi Moment Analysis
Multi Moment Analysis (MMA) or work sampling is a
innovative statistical technique that has been developed
by our consultants at Vialis AG and is now offered by
me2any AG (check out www.multimomentanalysis.com).
MMA enables you to gain data and information about
your enterprise and work procedures previously
unattainable. The MMA study will provide accurate data
and facts about the effort distribution throughout your
enterprise. Consequently you will be able to distinguish
value-added tasks and activities from waste-of-time. An
MMA study provides very reliable facts of the current
situation. Efficiency killers and bloated administrative
routines will be identified unambiguously and easily.
The MMA study uses modern mobile technology to
effortlessly collect data from all participants. The MMA
study is entirely anonymous and hence compliant with
personal data protection policies.
Value Proposition
Benefits (Value)
• Accurate quantitative data of effort distribution across
any relevant dimension (organisation, role, site, project,
etc.)
• Industry benchmark comparison with peers
• Identification of efficiency killers and bottlenecks
• Baseline for improvement potential, also independent
of the final solution
• Basis for business case and ROI calculation
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MMA Preparation
The MMA set-up is tailored to the
specific needs and goals of the
customer. Depending on project
goals, additional dimensions and
reference parameters are defined.
Based on the process analysis our
MMA experts will prepare the MMA
task list and review it with the
subject matter experts.
The MMA configuration is adapted
to guarantee compliance with all
data protection requirements.
MMA Recording
Following a short training session,
participants will be able to test the
application in test-mode. During this
time our consultants will assist users
on-site.
The actual measurement takes 2-3
weeks during which we monitor
incoming results, adapt study setup if
necessary and provide remote
assistance.
Already during the monitoring phase
intermediate reports can be
provided.
Multi Moment Analysis
Value Proposition
Statistical Analysis
After data collection completion, our
MMA experts perform a statistical
evaluation of the data and compile
the MMA report with conclusions
and estimates for the improvement
potential of a end-to-end solution or
any other improvement project
identified.
Data-drilldowns and customised
analysis depending on the insights
uncovered initially can yield further
potential.
Deliverables
• Goal definition
• Master data (tasks, users,
organisations, additional
dimensions)
• MMA configuration & statistical
parameters
• Data anonymization if necessary
Deliverables
• Training and launch
• MMA monitoring
• Intermediate reports
• Support
Deliverables
• Statistical analysis
• Reporting
• Conclusions and estimation of the
improvement potential
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Have you asked yourself the
following questions?
• How much time is wasted when electronically
available data is transferred manually?
• Is there time wasted and are there avoidable steps in
routine administration processes?
• Do errors and correction routines waste too much
time?
• Does data search and compilation take too much time?
• Do supervisors spend too much time on checks?
• Are the right people doing the right tasks?
• Can further automation in the context of data analysis
and reporting save time? How much?
• Is there slack in up-dating routines, master data
management or other routine tasks?
Value Proposition
If you answer one or more questions with “yes”
contact us to learn how we can help your organization
improve performance by up to 30%.
„I would have never expected so many efficiency killers and time wasters
among our processes. It was shocking and a wake-up call for improvement.“
Customer MMA Study Project Lead
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X-ray your organisation with Multi Moment Analysis
The MMA methodology provides an unprecedented way to record worktime very accurately
across processes and interpret the data in many dimensions to expose efficiency killers.
Value Proposition
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Concept Development
Based on the qualitative process & systems analysis and
optionally the results from the Multi Moment Analysis, our
senior consultants will perform an in-depth investigation.
Considering industry best practice and paperless lab
principles, we will develop a thorough functional gap
analysis, considering all necessary functionality for an
optimal process. Combined with a gap analysis of the
current, legacy system landscape, several potential
solution scenarios are developed, under careful
consideration of all necessary guiding principles like
regulations, quality- and user centricity requirements.
As an output of the investigation we will develop several,
vendor independent solution scenarios and discuss pros
and cons including a comprehensive SWOT-analysis and
financial considerations.
Supporting your company in selecting the optimal
solution scenario concludes the concept phase, resulting
in a well informed decision for one scenario to be
realized.
Value Proposition
Benefits (Value)
• Evaluation of current situation against industry best
practice and paperless lab principles
• High-impact functional requirement list
• Functional gap analysis and system coverage
• Suggested solutions scenarios with SWOT analysis
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Best Practice Analysis
Present processes are compared
with industry best practice.
Strengths and weaknesses are
highlighted and improvement
measures are suggested.
Paperless lab principles, best
Practices and regulatory require-
ments are discussed and
implemented.
Gap Analysis
High-impact functional require-
ments are listed and compared
against available systems
capabilities. Functional gaps and
system gaps are highlighted and
discussed.
Based on the results from the MMA
study an optimisation potential is
estimated.
Concept
Value Proposition
Solution Scenarios
Today’s lab informatics market is a
maze of competing software
products with largely overlapping
functional coverage. We will help
you to find the best solution(s) that
fit your current needs and support
your strategy going forward.
We will uncover pros and cons of
various solution scenarios, product
categories and suggest suitable
vendors.
Deliverables
• As-is status evaluation
• Paperless lab principles
Deliverables
• High-impact functional
requirement list
• Functional gap analysis
• System gap analysis
• Optimisation potential
Deliverables
• Solution scenarios
• Functional coverage analysis
• SWOT analysis
• Vendor solution list
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Future state and roadmap
The realization of highly efficient and automated scientific
business processes depends on smartly designed future
workflows and a fully integrated system landscape.
A well chosen level of harmonization of processes,
organizations and systems across the organization is key
to achieve highly efficient automated lab processes.
Our senior consultants will run to-be process workshops
with your process owners and subject matter experts with
the aim to design company-wide, sustainable &
harmonized processes.
User requirement specifications for current and additional
systems are derived from the developed to-be processes
and documented for later use in the vendor selection
process.
Our consultants help you to define a realistic systems
implementation roadmap and to estimate required
resources and costs.
Value Proposition
Benefits (Value)
• Organisation-wide harmonised processes
• Streamlined highly efficient future workflows
• Well planned explicit system requirement
specifications
• Transparent system implementation roadmap
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To-Be Process Workshops
During vivid workshops facilitated by
our consultants, process owners and
experts from involved organizations
will harmonize and define future
processes and workflows.
Our consultants will prepare and
lead the workshops and capture the
to-be processes in flow charts with
explicit task descriptions.
User Requirement Definition
Based on the defined to-be
processes a list of requirements will
be established. These include
functional user-, GxP / 21 CFR Part
11, technical-, performance-, and
security-related requirements.
The requirement list will be later
used for establishing RFI’s / RFP’s /
RFQ’s during the vendor selection
process.
Future state and roadmap
Value Proposition
Implementation Planning
Our consultants assist your
business- and IT department to
define a roll-out strategy and advise
on resources and funding needed,
be it simply for one lab or for multi-
site, multi-organisation and long-
term implementation roadmaps.
Deliverables
• Future to-be process
description
Deliverables
• Requirement list
Deliverables
• High-level implementation
roadmap
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Business Case
Life science lab Informatics projects are often costly and
can potentially absorb substantial internal resources over
a significant time period.
Such projects require a well thought out financial
evaluation before they are presented to the board.
Our consultants have an MBA-level finance background
and the necessary experience to help you prepare your
business case based on the chosen investment scenario
and expected benefits from the project.
Value Proposition
Benefits (Value)
• Higher success chance for board approval of funding
requested through well-prepared and documented
business cases
• Sound financial investment with reduced failure-risk
• Transparency of cost and required resources over
entire systems roll-out phase
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Financial Model
Based on established financial base
models for the specific area, our
consultants adapt and fine tune
these models in cooperation with
your subject matter experts to
capture your organisations relevant
cash flows.
Further refined are the models by
incorporating the effects of the
chosen solution scenarios.
Target & Input Definition
In cooperation with your CAPEX
experts, targets for the business
case are defined. An early
involvement of key stakeholders
from the finance department
ensures the business case meets
their requirements.
The customised financial models
provide a comprehensive list of all
the necessary financial input and
can be further refined with input
from finance.
Business Case
Value Proposition
Business Case
Our consultants will analyse and
document all project relevant costs
and benefits over the defined period.
Uncertainties are included in the
calculations and discussed as part of
the project risk analysis. These can
be further explored with a sensitivity
analysis if necessary.
A business summary is provided
with all relevant financial Indicators.
Deliverables
• Adapted financial model
Deliverables
• Clear definition of target values
• Financial model adapted to
internal needs and standards
• Input parameters & values
Deliverables
• Business case containing:
- ROI calculations
- Project net present value (NPV)
- Project risk analysis
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Solution Selection Support
PEPR-Consulting is an unbiased vendor-neutral partner
for your solution and vendor selection process.
Trying to determine the best solution for your laboratory
organization can be a confusing, frustrating and daunting
task, but the steps taken so far will help tremendously in
navigating this maze. Additionally, our consultants are
well experienced in guiding and supporting organisations
through the solution selection process.
We help you define and document requirement
specifications, prepare, organize and help evaluate
demo-sessions with short-listed vendors and provide
precious advice during your procurement process to
make sure you find the optimal products, and equally
important, the optimal partners going forward.
Value Proposition
Benefits (Value)
• Well defined and documented requirement
specifications
• Gain time by finding and short-listing suitable vendors
and software solutions
• Tailored, need-oriented demo-sessions
• Customised to your procurement process
• Find the best solution for your lab organisation
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Demo Sessions
Our consultants help you to develop
meaningful demo-scripts that cover
the most important workflows and
functional requirements that need to
be supported by the specific
software solution. This selection is
based on the tangible value for your
organisation, not just the latest
features of a software solution.
Finally, our consultants knowledge of
the solutions on the market ensures
discerning demo sessions.
Vendor Assessment
PEPR-consulting is vendor-neutral
and supports customers in short-
listing suitable software vendors and
assessing their products according to
defined requirement specifications,
technological performance and
integration capability within the
existing system landscape.
Solution Selection Support
Value Proposition
RFI / RFP / RFQ Preparation
We support your purchasing team
and business-IT team to create
typical documents needed within the
procurement process: request for
information, request for proposal and
request for quotation.
Deliverables
• Demo session scripts
• Value-based selection of most
important requirements
• Organised vendor-demo sessions
Deliverables
• Vendor score-card
• Recommendations and decision
support
Deliverables
• RFx - documents
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Solution Deployment
With more than 20 years experience of delivering
effective solutions, wega Informatik AG has established as
a quality service provider for the Life Science R&D and IT
sector. Our detailed attention to customers’ needs has
resulted in successful open and interactive partnerships
based on trust.
Our team of 35+ qualified experienced consultants has a
track record of providing first class service. Wega experts
have experience with most major Life Science software
solutions and have the capability to deploy complex
software solutions and manage global projects.
We Value and we strive for:
Competence Vision and expertise
Technology Knowledge and precision
Neutrality Vendor independence and objectivity
Partnership Mutual trust and synergies
Continuity Reliability and quality over time
Value Proposition
Benefits (Value)
• Professional solution engineering and implementation
planning
• Software testing and CSV planning and support
• Software customizing for specific solutions
• DBA Services and consulting
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IT Projects : Plan – Build – Run
Our well-rehearsed development
team is capable to drive complex
multi-site projects on tight time-
lines.
Our PMI-certified project managers
support various methodologies such
as waterfall or agile project
management.
CSV & QA
We make sure that you stand not
alone with testing and validation of
your software solution.
We support risk-based (GAMP 5)
validation strategies & GxP validation
documents. We provide CSV
templates & governance concepts.
Business Case
Value Proposition
Software Maintenance & SLA
Our technical team has a broad
technological skill set and is able to
support individual and customer-
specific SLA’s on most software
solutions.
Deliverables
• Detailed PMI project plan
• Highly qualified resources
• Project quality management
Deliverables
• Validation strategy
• GxP validation documents
• CSV templates
• Structured hand-over process
Deliverables
• Customer-specific SLA’s
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Strategic Consulting Partners
A big part of our success is the knowledge of our
customers’ needs and continued teamwork over a long
time period, actively cultivating a mutually beneficial
partnership.
A comprehensive, sustainable lab IT strategy is not only a
long bet, but also a dynamic one: Technology develops at
a tremendous pace and companies change equally fast,
requiring periodic review and adaption.
This is why PEPR-Consulting and wega Informatik AG are
your ideal long-term strategic partners.
Value Proposition
We therefore actively support you in:
• Project portfolio / program management
• Advise steering committees on strategy, status and
corrective action on ongoing projects
• Renewal / update of yearly budget
• Periodic revision and adaption of concept and plan,
helping to keep up focus and alignment
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Complementary Services
Value Proposition
Complementing our comprehensive offering of a
complete, seven-step paperless lab consulting roadmap,
we also provide ancillary services that can be tailored to
your specific needs :
MMA services, also for non-lab applications and
organisations (e.g. manufacturing, QA, regulatory…)
• Project management
• User & functional requirements development
• System validation support (GAMP 5)
• Regulatory consulting
• LEAN / Six Sigma / Kaizen
• Training and seminars