Roadmap to next generation digital lab

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 thecomplexity 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% efficiencyimprovements for major European Life Science companies lab operations.

We are lab-experienced chemists with a solid background in business administration andmanagement, a passion for sustainable process improvements and in-depth knowledge of labinformatics. Originating from the renowned "Vialis paperless lab solutions" team, PEPR-Consulting continues its tradition of successful strategic management consulting for the lifescience industry.

Our strengths are the deep understanding of your lab processes, current GxP requirementsand a broad and independent knowledge of lab informatics solutions available today and thetrends 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 yourneeds and pain-points and are happy to present our success-proven program to yourorganisation and propose solutions for building highly efficient and compliant self-documentingprocesses.

We are associated with wega Informatik AG who complements our knowledge with in-depthsavoir-faire in lab & research IT, CSV & QA, clinical development and IT solutions deployment.

Introduction

Stephan Gürtler

Chemist Dipl-Ing. FH, MBARochester-Bern

Stephan has over 20 yearsexperience in quality, regulatoryand laboratory managementwithin food-, pharma- andchemical Industries.

He worked as a seniormanagement consultant withinVialis AG and later Accelrys andDassault Systèmes BIOVIA wherehe was responsible for conceptualplanning and implementation ofglobal paperless solutions for drugproduct development and qualitycontrol.

Andreas Schild

Chemist Dipl-Ing. FH, MBAInnovation Management, Bern

Andreas looks back on over 15years of experience in thepharmaceutical industry asmanager, project leader and seniorconsultant.

He led the managementconsultant team with Vialis AG andits successors. Together with histeam, he developed the currentconsulting methodology andspecifically the Multi MomentAnalysis as a modern digitalmethod for measuring processefficiency.


„Coming together is a beginning; keeping together is progress; working together is success.”Henry Ford


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-issituation analysis and facilitate your change to a 20-30% higher performance with betterautomated and integrated work processes. We will support you in optimizing existingassets, selecting optimal additional solutions and support your business case for justifyingits 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 & SystemsAnalysis

Multi Moment Analysis

ConceptFuture

State and Roadmap

Business Case

Solution Selection Support

Solution Deployment


As-Is Process and Systems Analysis

The first step is a sound as-is process and systemsanalysis, being the stepping stone for a successfulimprovement project. Our senior consultants are lab-experienced experts in regulated environments, practisedand trained to ask the relevant questions.

On-site interviews with your process and system expertsserve multiple purposes: mutual understanding of the as-is situation, identification of the challenges and pain pointsand first improvement ideas from the local subject matterexperts.

A thorough and detailed documentation serves as theknowledge base for all further steps.

Pain points and available KPI’s are assessed anddocumented as a baseline for the improvement potential.

As part of this situation assessment we will analyse yourcurrent system landscape as well as your current mid- tolong 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


Process Analysis

During process analysis our seniorconsultants will interview yourprocess owners and capture allprocess flows at the relevant level ofdetail.

A thorough and detailed processdocumentation will be compiled,serving multiple purposes:knowledge base, improvementbaseline and requirements source.

System Analysis

Together with your IT-experts wewill draw an outline of your existingsystem landscape and collectinformation about its currentperformance. We will also look atcurrent implementation projects andconsider your mid- to long term ITstrategy.

As-Is Process and Systems Analysis

Value Proposition

Metrics

As part of the as-is situationassessment, a baseline of availablecurrent KPI’s will be documented.

Additionally, we will also identify andcapture 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



Multi Moment Analysis (MMA) or work sampling is ainnovative statistical technique that has been developedby our consultants at Vialis AG and is now offered byme2any AG (check out www.multimomentanalysis.com).

MMA enables you to gain data and information aboutyour enterprise and work procedures previouslyunattainable. The MMA study will provide accurate dataand facts about the effort distribution throughout yourenterprise. Consequently you will be able to distinguishvalue-added tasks and activities from waste-of-time. AnMMA study provides very reliable facts of the currentsituation. Efficiency killers and bloated administrativeroutines will be identified unambiguously and easily.

The MMA study uses modern mobile technology toeffortlessly collect data from all participants. The MMAstudy is entirely anonymous and hence compliant withpersonal 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

http://www.multimomentanalysis.com/


MMA Preparation

The MMA set-up is tailored to thespecific needs and goals of thecustomer. Depending on projectgoals, additional dimensions andreference parameters are defined.

Based on the process analysis ourMMA experts will prepare the MMAtask list and review it with thesubject matter experts.

The MMA configuration is adaptedto guarantee compliance with alldata protection requirements.

MMA Recording

Following a short training session,participants will be able to test theapplication in test-mode. During thistime our consultants will assist userson-site.

The actual measurement takes 2-3weeks during which we monitorincoming results, adapt study setup ifnecessary and provide remoteassistance.

Already during the monitoring phaseintermediate reports can beprovided.


Value Proposition

Statistical Analysis

After data collection completion, ourMMA experts perform a statisticalevaluation of the data and compilethe MMA report with conclusionsand estimates for the improvementpotential of a end-to-end solution orany other improvement projectidentified.

Data-drilldowns and customisedanalysis depending on the insightsuncovered initially can yield furtherpotential.

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


Have you asked yourself the following questions?

• How much time is wasted when electronicallyavailable data is transferred manually?

• Is there time wasted and are there avoidable steps inroutine administration processes?

• Do errors and correction routines waste too muchtime?

• 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 analysisand reporting save time? How much?

• Is there slack in up-dating routines, master datamanagement 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


X-ray your organisation with Multi Moment Analysis

The MMA methodology provides an unprecedented way to record worktime very accuratelyacross processes and interpret the data in many dimensions to expose efficiency killers.

Value Proposition


Concept Development

Based on the qualitative process & systems analysis andoptionally the results from the Multi Moment Analysis, oursenior consultants will perform an in-depth investigation.

Considering industry best practice and paperless labprinciples, we will develop a thorough functional gapanalysis, considering all necessary functionality for anoptimal process. Combined with a gap analysis of thecurrent, legacy system landscape, several potentialsolution scenarios are developed, under carefulconsideration of all necessary guiding principles likeregulations, quality- and user centricity requirements.

As an output of the investigation we will develop several,vendor independent solution scenarios and discuss prosand cons including a comprehensive SWOT-analysis andfinancial considerations.

Supporting your company in selecting the optimalsolution scenario concludes the concept phase, resultingin a well informed decision for one scenario to berealized.

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


Best Practice Analysis

Present processes are comparedwith industry best practice.Strengths and weaknesses arehighlighted and improvementmeasures are suggested.

Paperless lab principles, bestPractices and regulatory require-ments are discussed andimplemented.

Gap Analysis

High-impact functional require-ments are listed and comparedagainst available systemscapabilities. Functional gaps andsystem gaps are highlighted anddiscussed.

Based on the results from the MMAstudy an optimisation potential isestimated.

Concept

Value Proposition

Solution Scenarios

Today’s lab informatics market is amaze of competing softwareproducts with largely overlappingfunctional coverage. We will helpyou to find the best solution(s) thatfit your current needs and supportyour strategy going forward.

We will uncover pros and cons ofvarious solution scenarios, productcategories and suggest suitablevendors.

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


Future state and roadmap

The realization of highly efficient and automated scientificbusiness processes depends on smartly designed futureworkflows and a fully integrated system landscape.

A well chosen level of harmonization of processes,organizations and systems across the organization is keyto achieve highly efficient automated lab processes.

Our senior consultants will run to-be process workshopswith your process owners and subject matter experts withthe aim to design company-wide, sustainable &harmonized processes.

User requirement specifications for current and additionalsystems are derived from the developed to-be processesand documented for later use in the vendor selectionprocess.

Our consultants help you to define a realistic systemsimplementation roadmap and to estimate requiredresources 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


To-Be Process Workshops

During vivid workshops facilitated byour consultants, process owners andexperts from involved organizationswill harmonize and define futureprocesses and workflows.

Our consultants will prepare andlead the workshops and capture theto-be processes in flow charts withexplicit task descriptions.

User Requirement Definition

Based on the defined to-beprocesses a list of requirements willbe established. These includefunctional user-, GxP / 21 CFR Part11, technical-, performance-, andsecurity-related requirements.

The requirement list will be laterused for establishing RFI’s / RFP’s /RFQ’s during the vendor selectionprocess.

Future state and roadmap

Value Proposition

Implementation Planning

Our consultants assist yourbusiness- and IT department todefine a roll-out strategy and adviseon 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


Business Case

Life science lab Informatics projects are often costly andcan potentially absorb substantial internal resources overa significant time period.

Such projects require a well thought out financialevaluation before they are presented to the board.

Our consultants have an MBA-level finance backgroundand the necessary experience to help you prepare yourbusiness case based on the chosen investment scenarioand 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


Financial Model

Based on established financial basemodels for the specific area, ourconsultants adapt and fine tunethese models in cooperation withyour subject matter experts tocapture your organisations relevantcash flows.

Further refined are the models byincorporating the effects of thechosen solution scenarios.

Target & Input Definition

In cooperation with your CAPEXexperts, targets for the businesscase are defined. An earlyinvolvement of key stakeholdersfrom the finance departmentensures the business case meetstheir requirements.

The customised financial modelsprovide a comprehensive list of allthe necessary financial input andcan be further refined with inputfrom finance.

Business Case

Value Proposition

Business Case

Our consultants will analyse anddocument all project relevant costsand benefits over the defined period.Uncertainties are included in thecalculations and discussed as part ofthe project risk analysis. These canbe further explored with a sensitivityanalysis if necessary.

A business summary is providedwith 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



PEPR-Consulting is an unbiased vendor-neutral partnerfor your solution and vendor selection process.

Trying to determine the best solution for your laboratoryorganization can be a confusing, frustrating and dauntingtask, but the steps taken so far will help tremendously innavigating this maze. Additionally, our consultants arewell experienced in guiding and supporting organisationsthrough the solution selection process.

We help you define and document requirementspecifications, prepare, organize and help evaluatedemo-sessions with short-listed vendors and provideprecious advice during your procurement process tomake sure you find the optimal products, and equallyimportant, 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


Demo Sessions

Our consultants help you to developmeaningful demo-scripts that coverthe most important workflows andfunctional requirements that need tobe supported by the specificsoftware solution. This selection isbased on the tangible value for yourorganisation, not just the latestfeatures of a software solution.

Finally, our consultants knowledge ofthe solutions on the market ensuresdiscerning demo sessions.

Vendor Assessment

PEPR-consulting is vendor-neutraland supports customers in short-listing suitable software vendors andassessing their products according todefined requirement specifications,technological performance andintegration capability within theexisting system landscape.


Value Proposition

RFI / RFP / RFQ Preparation

We support your purchasing teamand business-IT team to createtypical documents needed within theprocurement process: request forinformation, request for proposal andrequest 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


Solution Deployment

With more than 20 years experience of deliveringeffective solutions, wega Informatik AG has established asa quality service provider for the Life Science R&D and ITsector. Our detailed attention to customers’ needs hasresulted in successful open and interactive partnershipsbased on trust.

Our team of 35+ qualified experienced consultants has atrack record of providing first class service. Wega expertshave experience with most major Life Science softwaresolutions and have the capability to deploy complexsoftware 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


IT Projects : Plan – Build – Run

Our well-rehearsed developmentteam is capable to drive complexmulti-site projects on tight time-lines.

Our PMI-certified project managerssupport various methodologies suchas waterfall or agile projectmanagement.

CSV & QA

We make sure that you stand notalone with testing and validation ofyour software solution.

We support risk-based (GAMP 5)validation strategies & GxP validationdocuments. We provide CSVtemplates & governance concepts.

Business Case

Value Proposition

Software Maintenance & SLA

Our technical team has a broadtechnological skill set and is able tosupport individual and customer-specific SLA’s on most softwaresolutions.

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


Strategic Consulting Partners

A big part of our success is the knowledge of ourcustomers’ needs and continued teamwork over a longtime period, actively cultivating a mutually beneficialpartnership.

A comprehensive, sustainable lab IT strategy is not only along bet, but also a dynamic one: Technology develops ata tremendous pace and companies change equally fast,requiring periodic review and adaption.

This is why PEPR-Consulting and wega Informatik AG areyour 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


Complementary Services

Value Proposition

Complementing our comprehensive offering of acomplete, seven-step paperless lab consulting roadmap,we also provide ancillary services that can be tailored toyour specific needs :

MMA services, also for non-lab applications andorganisations (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

[email protected] [email protected]

www.pepr-consulting.com www.wega-it.com

+41 79 258 09 51 +41 61 270 87 87

mailto:[email protected]

mailto:[email protected]

http://www.pepr-consulting.com/

http://www.wega-it.com/

tel:+41345085576

tel:+41612708787