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Strategic Consulting Partners in Life Science
for a High Performing Paperless Lab
2 | PEPR proprietary and confidential
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.
PEPR proprietary and confidential | 3
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.
4 | PEPR proprietary and confidential
„Coming together is a beginning; keeping together is
progress; working together is success.”
Henry Ford
PEPR proprietary and confidential | 5
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
6 | PEPR proprietary and confidential
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
PEPR proprietary and confidential | 7
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
8 | PEPR proprietary and confidential
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
PEPR proprietary and confidential | 9
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
10 | PEPR proprietary and confidential
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
11 | PEPR proprietary and confidential
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
12 | PEPR proprietary and confidential
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
PEPR proprietary and confidential | 13
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
14 | PEPR proprietary and confidential
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
PEPR proprietary and confidential | 15
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
16 | PEPR proprietary and confidential
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
PEPR proprietary and confidential | 17
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
18 | PEPR proprietary and confidential
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
PEPR proprietary and confidential | 19
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
20 | PEPR proprietary and confidential
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
PEPR proprietary and confidential | 21
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
22 | PEPR proprietary and confidential
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
PEPR proprietary and confidential | 23
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
Contact us
Copyright © 2016 by PEPR Consulting. All rights reserved. This brochure or any portion thereof may not be reproduced or used in any manner whatsoever without the
express written permission of the publisher. www.pepr-consulting.com
We would be happy to discuss the specifics of your improvement opportunities with you.
Please contact us by email, web or phone:
PEPR-Consulting Wega Informatik AG
info@pepr-consulting.com info@wega-it.com
www.pepr-consulting.com www.wega-it.com
+41 79 258 09 51 +41 61 270 87 87

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Roadmap to next generation digital lab

  • 1. Strategic Consulting Partners in Life Science for a High Performing Paperless Lab
  • 2. 2 | PEPR proprietary and confidential 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.
  • 3. PEPR proprietary and confidential | 3 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.
  • 4. 4 | PEPR proprietary and confidential „Coming together is a beginning; keeping together is progress; working together is success.” Henry Ford
  • 5. PEPR proprietary and confidential | 5 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
  • 6. 6 | PEPR proprietary and confidential 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
  • 7. PEPR proprietary and confidential | 7 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
  • 8. 8 | PEPR proprietary and confidential 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
  • 9. PEPR proprietary and confidential | 9 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
  • 10. 10 | PEPR proprietary and confidential 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
  • 11. 11 | PEPR proprietary and confidential 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
  • 12. 12 | PEPR proprietary and confidential 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
  • 13. PEPR proprietary and confidential | 13 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
  • 14. 14 | PEPR proprietary and confidential 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
  • 15. PEPR proprietary and confidential | 15 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
  • 16. 16 | PEPR proprietary and confidential 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
  • 17. PEPR proprietary and confidential | 17 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
  • 18. 18 | PEPR proprietary and confidential 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
  • 19. PEPR proprietary and confidential | 19 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
  • 20. 20 | PEPR proprietary and confidential 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
  • 21. PEPR proprietary and confidential | 21 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
  • 22. 22 | PEPR proprietary and confidential 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
  • 23. PEPR proprietary and confidential | 23 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
  • 24. Contact us Copyright © 2016 by PEPR Consulting. All rights reserved. This brochure or any portion thereof may not be reproduced or used in any manner whatsoever without the express written permission of the publisher. www.pepr-consulting.com We would be happy to discuss the specifics of your improvement opportunities with you. Please contact us by email, web or phone: PEPR-Consulting Wega Informatik AG info@pepr-consulting.com info@wega-it.com www.pepr-consulting.com www.wega-it.com +41 79 258 09 51 +41 61 270 87 87