Paperless Lab Academy® 2017

Transform scientific 2020 information into Roadmap for actionable insight digital convergence

Barcelona, April 4th & 5th

Paperless Lab Academy® 2017

@Paperless_Lab Paperless Lab Academy www.paperlesslabacademy.com ® Sponsors & Partners Paperless Lab Academy 2017

SCIENTIFIC Digital Convergence 2020 Roadmap for

2 ® Welcome Paperless Lab Academy 2017 Welcome

Welcome from the congress organizers

RA Content EB TIN EL G C Paperless Lab Welcome to the fifth edition of the Paperless Lab Academy. When we initiated our brainstorm Academy® on the most suitable central theme for this new edition, we realized that in previous ones we focused on change management and in ways to speed the innovation having in the 2020 years5 target set in most of the companies.

Yet as of today, not all projects neither data strategies have already been clearly defined. Program

Therefore, we end up with a very pragmatic central theme to provide you with relevant in- formation to define your 2020 Roadmap for digital convergence. A call to action for you to transform your scientific information into actionable insight.

We are pleased to welcome our three knowledgeable keynote speakers, Mr. Louis Halvorsen - Chief Technical Officer at Northwest Analitycs, Mr. Michael Shanler - Research Vice Pres- ident (Industry Analyst) from Gartner, and Ms. Sofie van der Meulen - Attorney at Law from Presentation Axon Lawyers.

From their respective angles, they’ll take us from the data to the Internet of Laboratory Things (IoLT) and help you visualize how your laboratory data could contribute to the busi- ness decision process.

20 interactive sponsored workshops are on the menu this year, an amazing showcase op- portunity for all visitors to get to know the latest and greatest on solutions and methodolo- gies in less than 2 days. Workshop

In short, we’ll be investigating how the convergence of paper and digital is bringing a new dimension to laboratory informatics. The use of data analytics and the lessons learnt from other industries while adopting an Industry 4.0 mind-set, will accelerate and ease the inte- gration of scientific equipment with enterprise software.

We hope that you’ll find here the answers you’re looking for, benefit from your peers’ experi- ences and enjoy the networking sessions. Thanks to our partners who made it possible once again to offer free regitration to the industry visitors.

It is our pleasure to welcome you to this fifth edition of the Paperless Lab Academy under a new management yet still same trio of domain experts in the organization committee. Digital Convergence 2020 Roadmap for

Isabel Muñoz-Willery Ph.D Peter Boogaard Roberto Castelnovo Founder & Owner at NL42 Founder & CEO at ILA Founder & Owner at NL42 Owner & Organizer of PLA Founder & Organizer of PLA Owner & Organizer of PLA

MANAGEMENT CONSULTING Making the Complex Simple 3 ® Content - Day 1 Paperless Lab Academy 2017

Sponsors & partners 2

Welcome from the congress organizers 3

Program Day 1 - April 4TH 6

Chairman’s welcoming address Industrial Lab Automation 9

Cocktail reception sponsored by Scientific Computing World 10

Transforming lab data into real-time actionable operational Northwest Analytics 11

Holistic management of analytical and biological data for bioprocess development using AnIML Sanofi Aventis 12

Integrating analytic data, tools and software through Allotrope Framework Bayer 13

Manipulating chromatography data for fun and profit Lilly 15

Integrating laboratory informatics with a process intelligence system for parenteral and oral formulations Bristol-Myers Squibb 16

A holistic approach to tactical and strategic business information Spreitzenbarth Consultants 17

Olympic LIMS experiences in anti-doping laboratory French anti-doping agency (AFLD) 19

Key efficiency drivers of quality control laboratories in the pharmaceutical industry University of St. Gallen 21

Exploring the digital potential for laboratory of the future Gartner 22

DAMAS - Data Acquisition, Management and Analysis System - an integrated Electronic Lab Notebook @ work Roche Diagnostics 23

Transformational solutions start with a comprehensive data strategy LabAnswer 25

ProLab, a unique and innovative module for project traceability and system validation Agilab 27

Digital data convergence, regulatory audit support and the development of PAT and QbD Spreitzenbarth Consultants 29

NevisData: Hardware-cloud software hybrid solution or how to control the variable that affects the results Instrumentos Científicos S.A. (ICSA) 30

Present and future collaborative innovations within drug discovery informatics Collaborative Drug Discovery 31

Data integrity - How will the new DI regulations affect your organization LabWare 35 Digital Convergence

2020 Roadmap for Building a better business case Lonza 37

Lessons learned and things to remember when migrating from on premise to cloud IDBS 39

Why an IoT-platform is essential for a sustainable digitization of laboratory processes cubuslab GmbH 41

4 ® Content - Day 2 Paperless Lab Academy 2017 Welcome

Program Day 2 - April 5TH 44

Chairman’s welcoming address NL42 Consulting 47

IoLT and information governance: understanding and attacking the business, technical and legal issues Axon Lawyers 49 Content How to use your lab data for tech transfer and better decision making Dassault Systèmes Biovia 51

A platform and application approach to genomics and biologics R&D Core Informatics 52

How data integrity elements & aspects are audited during inspections iVention 53

Improve your lab maturity with data science Osthus 55

Improving data integrity with end-to-end integration of ERP, LES, LIMS and analytical Program instruments with the AnIML data standard iCD. Vertriebs GmbH, BSSN Software GmbH 57

Data integrity? How to get the most out of your Empower data; have secured your MS Excel spreadsheets; and archived all your electronic data! Waters Corporation 59

Dealing with a lot of paperwork? Learn how laboratory informatics simplifies the complexity of compliance with data integrity Abbott Informatics 61 Presentation Collaboration to insight: Closing the gap between data capture and real time decisions PerkinElmer 63

Unlock the value of your data with integrated lab and data management combined with cloud capabilities Thermo Fisher Scientific 65

An integrated lab informatics workflow for antibody discovery Dotmatics Ltd 67

Eliminate the laboratory process pains & enhance compliance assurance Kneat Solutions Ltd. 69 Workshop Data governance: Answering the ALCOA-based data integrity and data quality topics and to the lifecycle of your data Mettler Toledo 71

Practical approaches for an effective data governance programme Lonza 72

Version control: The software industry’s solution to data integrity problems Vetter Pharma-Fertigung GmbH & Co.KG 73

Management of research data in academia: development of a modern research infrastructure with open source software Karlsruhe Institute of Technology (KIT) 75

Internet of Lab Things – Visualizing your data and yielding important results without an army of data scientists Astrix Technology Group 77 Digital Convergence

Media Partners 79 2020 Roadmap for

5 ® Program Paperless Lab Academy 2017

DAY 1 - APRIL 4TH

From 08:00 REGISTRATION - MAIN LOBBY

PETER BOOGAARD 08:40 - 09:00 Chairman’s welcoming address Event founder at ILA

Keynote: Transforming lab data into LOUIS HALVORSEN 09:00 - 09:40 real-time actionable operational Chief Technical Officer intelligence

Holistic management of analytical JENS UNGER 09:40 - 10:00 and biological data for bioprocess Project Manager development using AnIML

Integrating analytic data, tools and HENNING KAYSER 10:00 - 10:20 software through Allotrope framework Global Lab Solutions- Bayer

10:20 - 11:00 COFFEE BREAK

Manipulating chromatography data for MARK NEWMAN 11:00 - 11:20 Assoc. Sr Quality Assurance fun and profit Consultant

Integrating laboratory informatics DADONG LI 11:20 - 11:40 with a process intelligence system for R&D Information Technology parenteral and oral formulations Director

A holistic approach to tactical and MARC VORDERMAN 11:40 - 12:00 strategic business information Chief Commercial Officer

Olympic LIMS experiences in anti- MS. ADELINE MOLINA 12:00 - 12:20 doping laboratory Deputy director

Key efficiency drivers of quality control THOMAS FRIEDLI 12:20 - 12:40 laboratories in the pharmaceutical PhD Director Institute of industry Technology Management

12:40 - 13:40 LUNCH Digital Convergence

2020 Roadmap for Keynote: Exploring the digital MICHAEL SHANLER 13:40 - 14:25 Research Vice President potential for laboratory of the future (Industry Analyst)

DAMAS - Data Acquisition, Management GEORG POLLINGER 14:25 - 14:45 and Analysis System - an integrated Business Process Owner Electronic Lab Notebook @ work DAMAS DSP non GMP

6 Paperless Lab Academy® 2017 Welcome

DAY 1 - APRIL 4TH

Transformational solutions start PAT PIJANOWSKI 14:45 - 15:05 Partner, Pharma & Life with a comprehensive data strategy Sciences Practicer SCIENTIFIC INFORMATICS Content

Workshop elevator pitches 15:05 - 15:15 Introduction to Workshops of sessions I & II

15:15 - 15:45 COFFEE BREAK

1A. ProLab, a unique and innovative MOHAMED-J. NDIAYE module for project traceability and

Chief Research Officer Program system validation

1B. Digital data convergence,

WORKSHOP 1 MARC VORDERMAN regulatory audit support and the Chief Commercial Officer development of PAT and QbD 15:50 - 16:50 1C. NevisData: Hardware-cloud software hybrid solution or how ÀLVAR CUEVAS I FAJARDO Project Manager Presentation to control the variable that affects (Lab Consultant & LIMS) the results

1D. Present and future collaborative KELLAN GREGORY innovations within drug discovery Director informatics of Product Excellence

2A. Data integrity - How will the new Workshop DI regulations affect your MARK GONZALEZ organization and how using Technical Director Labware LIMS & ELN can assist you with these

WORKSHOP 2 ROBERT LUTSKUS 2B. Building a better business case Global product Delivery Manager - Informatics 17:00 - 18:00

2C. Lessons learned and things to PAUL DENY GOULDSON remember when migrating from Vice President, on premise to cloud Strategic Solutions Digital Convergence 2020 Roadmap for 2D. Why an IoT-platform is essential DR. DOMINIC LÜTJOHANN for a sustainable digitization of Chief Executive Officer, laboratory processes co-founder

Cocktail sponsored by 19:00 - 20:30 WELCOME COCKTAIL Scientific Computing World

20:30 - 23:00 CONGRESS DINNER 7 Discover the enormous potential of paperless data management

It is pure waste to perform labor-intensive hunting for information across multi-vendor, multi-technique databases, manual transcription checking and manually creating reports. The need to be able to cross-functionally collaborate between research, development, quality assurance and manufacturing is exponentially expanding. Today's significant social and technological breakthroughs will require a fundamental re-think and re-design of how companies integrate new scientific processes.

We think with the end in mind. Unbiased and vendor neutral.

Making Informatics Work Across Your Teams

[email protected] ® Welcome Paperless Lab Academy 2017 Welcome Chairman’s welcoming address

name Peter J. Boogaard

company Industrial Lab Automation Content

job title CEO

email [email protected]

website www.industriallabautomation.com Program Data intensive science is becoming mainstream, To make this happen, we need to adjust our mind- and new technologies will change the dynamics how set and think in “capabilities” rather “technologies”. scientists will work together. Healthcare, banking, Do we really know what competencies are needed consumer industry have all adopted paperless and to transform scientific information into actionable electronic data integration approaches, which means insight for our new, and existing laboratory data that many technologies are now mainstream and consumers? available at our disposal. This is an exciting time for The objective of the 5th edition of the Paperless Lab our scientific community. Our challenge is however, Academy is to facilitate you, in creating your practical how to adopt these new cross-industry best practices Presentation digital 2020 convergence capability roadmap and get in our scientific world, with measurable benefits to answers during the many sessions ahead. assure funding. Workshop Digital Convergence 2020 Roadmap for

9 ® Cocktail reception Paperless Lab Academy 2017

Cocktail reception SPONSORED BY

Once again, Scientific Computing World and its parent company Europa Science are delighted to be involved in the Paperless Lab Academy here in Barcelona.

As in previous years were are proud to be the sponsor of the drinks reception, to which everyone is cordially invited, and we look forward to meeting as many of you as possible in what we hope will be a relaxed and enjoyable evening!

Scientific Computing World is the only global publication dedicated to the computing and information technology needs of scientists and engineers. It covers computing for science, engineering, and technology grouped under the headings of Informatics; High-Performance Computing; and Application software.

Laboratory Informatics software continues to drive users towards the development of the ‘Smart Laboratory’, where products ranging from Electronic Laboratory Notebooks through traditional Laboratory Information Management Systems (LIMS) to cloud-based and Product Lifecycle Management systems are not only speeding up the business of recording experiments but also enabling scientists to store and analyse data - helping laboratory users transform scientific information into actionable insight.

Scientific Computing World reports on developments in laboratory software, emerging technologies and challenges faced by laboratory users from the discovery and QA/QC laboratory as well as process-analytic quality assurance.

Scientific Computing World consists of a website www.scientific-computing.com, three electronic newsletters and a magazine that is available digitally by email and also in printed format. The magazine is distributed free of charge to readers who are interested in scientific computing and it is easy to subscribe online at www.scientific-computing.com/subscribe/ Digital Convergence 2020 Roadmap for

10 Paperless Lab Academy® 2017 Keynote DAY 1. 09:40-10:00 Welcome Transforming lab data into real-time actionable operational intelligence Content name Louis Halvorsen

company Northwest Analytics

job title Chief Technical Operator

email [email protected]

website www.nwasoft.com Program

Manufacturers in the Process Industries (chemicals/ and systemic issues that affect timeliness and petrochemicals, materials, pharmaceuticals, etc.) the ability of process engineers and managers to are increasingly under pressure to improve process effectively access and make use of the data. yields, efficiency, and asset utilization and to eliminate The challenge for LIMS managers is to ensure that unplanned downtime. Leading companies are turning their LIMS is part of the complex data integration to Enterprise Manufacturing Intelligence (EMI) Presentation process that includes Process Historians, quality solutions to achieve these goals. Pharmaceutical systems, MES, and ERP and that the data LIMS manufacturers are also being compelled by delivers is appropriate for real-time as well as long- regulators (FDA, EMA) to implement CPV (Continued term analytics. The increasing use of multivariate Process Verification) where CPV Stage 3 is the models to monitor complex manufacturing processes functional equivalent to EMI. adds to the challenge. Analytical laboratories are a key provider of data that This session will focus on how the current is essential for implementing EMI/CPV solutions, manufacturing information technology ecosystem with LIMS being the primary information system Workshop has evolved to support EMI initiatives and how LIMS responsible for managing this data. This gives managers can best contribute to the delivery of real laboratory managers a challenge and an opportunity EMI benefits for their organizations. Special to ensure that LIMS remains a significant contributor will be paid to the equivalence of CPV initiatives in to the success of the enterprise. Unfortunately, the Pharmaceutical manufacturing and EMI. apparent value of LIMS is often limited by technical Digital Convergence 2020 Roadmap for

11 Paperless Lab Academy® 2017 Presentation DAY 1. 09:00-09:40

Holistic management of analytical and biological data for bioprocess development using AnIML

name Jens Unger

company Sanofi Aventis

job title Project Manager

email [email protected]

website www.en.sanofi.com

Improving the efficiency and the turn-around time for eeAnalytical data from many assay types (HPLC, bioprocess development has a direct impact on the ELISA, SDS PAGE, …) time to market and manufacturing yield of a product. This presentation describes the Sanofi BIO PCS Increasing process understanding is a major success system which aggregates and visualizes data of all factor in process development. Bioprocesses bring three types and makes them available for analysis. together data from several domains: It also describes how the technique-neutral AnIML eeProcess data from bioreactors and purification data format is used to bring together all the data of a chromatography batch in a single format, so it can be interpreted with a common set of tools. eeNear-line data from in-process analytics (cell counters, bioanalyzers) Digital Convergence 2020 Roadmap for

12 Paperless Lab Academy® 2017 Presentation DAY 1. 10:00-10:20 Welcome Integrating analytic data, tools and software through Allotrope Framework Content

name Henning Kayser

company Bayer

job title Global Lab Solutions

email [email protected] Program

website www.bayer.com

In a joint approach from IT and analytical where data, methods and hardware components are communities, BAYER is a founding member of the seamlessly shared between disparate platforms, and Allotrope Foundation, an industry consortium of where one-click reports can be produced using data leading pharma and life science companies. Allotrope generated on any analytical instrument. Allotrope’s Presentation is developing an innovative, open framework for vision of an intelligent analytical laboratory will be managing analytical data throughout its complete realized through the creation of an open “ecosystem” lifecycle, using a common set of standard tools. in collaboration and consultation with vendors and the Allotrope aims to make the intelligent analytical analytical community. laboratory a reality – an automated laboratory Workshop Digital Convergence 2020 Roadmap for

13 Subscribe for free*

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Also published by Europa Science

Building a Smart Laboratory 2016 Laboratory Informatics Guide 2017 scienti c-computing.com/BASL2016 scienti c-computing.com/lig2017 Paperless Lab Academy® 2017 Presentation DAY 1. 11:00-11:20 Welcome Manipulating chromatography data for fun and profit Content name Mark Newton company Lilly

job title Assoc. Sr Quality Assurance Consultant

email

website www.lilly.com Program

Chromatography data is central to most laboratory and prevent such improper manipulations. operations. Unfortunately, even with a restrictive Presentation will offer some examples of improper configuration and procedural controls, there are a manipulation, discussing their motivations and number of ways for laboratory analysts and reviewers detection. Some examples will be obvious and others, to manipulate chromatography systems to make tests subtle. Examples will be based on Empower CDS, but or tested articles appear to be better than their true Presentation will be applicable to majority of other systems as well. condition. It is imperative that companies establish analytics and review practices that are able to detect Workshop Digital Convergence 2020 Roadmap for

15 Paperless Lab Academy® 2017 Presentation DAY 1. 11:20-11:40

Integrating laboratory informatics with a process intelligence system for parenteral and oral formulations

name Dadong Li

company Bristol-Myers Squibb

job title R&D Information Technology Director

email

website www.bms.com

For drug product formulation understanding the the data must be normalized before any analysis can process is paramount. For most formulators be conducted. In this type of environment where a retrieving all the data necessary to do any type of detailed understanding of process experimentation analysis is often a laborious endeavour. The data, can have a beneficial impact on drug product which includes process parameters, analytical results development the knowledge must be extracted in a and batch genealogy, is often dispersed across reasonable time frame. This presentation will discuss different electronic systems, exists in paper records, the implementation of a process intelligence system and resides with multiple individuals. Once data along with the benefits, challenges, and lessons collection is complete the formulator faces another learned in parenteral and oral formulation. challenge. Since data capture is not standardized Digital Convergence 2020 Roadmap for

16 Paperless Lab Academy® 2017 Presentation DAY 1. 11:40-12:00 Welcome A holistic approach to tactical and strategic business information Content

name Marc Vorderman

company Spreitzenbarth Consultants

job title Chief Commercial Officer

email [email protected] Program

website www.spcon.de

Today, companies are exploring big data strategies For example, how can critical process parameters and at the same time discover facts they didn’t know and critical quality attributes result in a model for before. Budget constraints, sustainability objectives, predictive process control. faster developments of products and services are This presentation will talk about the relatively Presentation important objectives for companies. widely discussed subjects like “Big Data”, “The This presentation will answer the question, how transformation of Data into Actionable Knowledge” as to adopt a holistic approach using (scientific) data well as the use of data for operational purposes and and the importance of the interconnection of data. strategic business decision making. Using advanced Do we understand how (scientific) data created analytics, businesses can mine big data to understand in, for example, our laboratories influence other the current state of the business and track still- departments within originations? A holistic approach evolving aspects such as customer behavior and

should look at all individual systems as a whole. . Workshop Digital Convergence 2020 Roadmap for

17 COMMUNICATE WITH THE LAB INDUSTRY

free registration until LABinsights.net 2018

your web portal company page knowledge sharing

monthly expertise newsletter center Paperless Lab Academy® 2017 Presentation DAY 1. 12:00-12:20 Welcome Olympic LIMS experiences in anti-doping laboratory Content name Ms. Adeline Molina

company French Anti-doping Agency (AFLD)

job title Deputy director

email

website www.en.afld.fr Program

The French Anti-doping Agency (AFLD) receive confirmation and, depending on the results, added anonymous athlete samplings from events all specialized analysis. The AFLD must comply with the around the world like: EuroFoot, Olympic games, Antidoping Mondial Agency (AMA) regulations with Tour de France and many others sport events. the threat to lose the accreditation. The presentation The samples are controlled in AFLD Labs with a will cover experiences offered by AgiLab LIMS

predefined process: screening, pre-confirmation, implementation in terms of compliance, organization Presentation Workshop Digital Convergence 2020 Roadmap for

19 Find more information: http://tectem.ch

St.Gallen Quality Control Lab Benchmarking Operational Excellence in QC Labs

What is the project about? What are your advantages? The Benchmarking exercise helps to assess your A personalized report shows your relative Operational Excellence (OPEX) Performance performance in KPIs in the following categories: and Maturity in the Quality Control (QC) Lab. . Productivity The joint development of the benchmarking with . Quality leading pharmaceutical companies ensured the . Service right scope of OPEX assessment in QC Labs. . Cost Efficiency It further reveals the implementation level of With the industry-tested holistic approach of the defined Enablers specific to your QC Lab. An St.Gallen OPEX Benchmarking we ensure a extract of a personalized report is available at: meaningful assessment of your QC Lab taking into http://tectem.ch/institute/opex/qclab-benchmarking account lab specific characteristics.

Key focus areas of the benchmarking It is important that OPEX is not only measured by performance outcomes but also by analyzing how an organization achieves this performance. To bring performance outcomes and enabling factors together provides a comprehensive picture of your lab’s OPEX Performance and Maturity. How efficient is the lab doing their job? Disclosed Productivity insights on utilization and usage of synergy effects. How effective is the lab doing their job? Quality Conclusions about process & product quality. Metrics Monitor both: Lab processing speed & adherence Service to schedule. Maintenance, technology assessment, house- Maintenance & Quality System keeping, and standardization & simplification. Mgmt. commitment & culture, employee involve- Planning & Steering System ment & improvement and functional integration.

Enablers Set-up reduction, pull approach, layout optimi- Management System zation, planning adherence and visual mgmt. Contact us for more information Prof. Dr. Thomas Friedli Stephan Köhler Professor for Production Mgmt. [email protected] University of St.Gallen +41 (0)71 224 72 71 Paperless Lab Academy® 2017 Presentation DAY 1. 12:20-12:40 Welcome Key efficiency drivers of quality control laboratories in the pharmaceutical industry Content name Prof. Dr. Thomas Friedli company University of St. Gallen Professor for Production Management job title and Director Institute of Technology Management email [email protected] website www.item.unisg.ch Program

In the world of pharmaceutical manufacturing, it is of an assessment tool the Institute of Technology universally understood that a robust quality control Management and selected pharmaceutical laboratory represents one of the key elements of companies co-developed an operational excellence quality assurance and on-time product release for benchmarking in 2016 - specifically for quality control every pharmaceutical manufacturing company. laboratories.

It ensures that patients are timely provided with Presentation It is fundamentally important to identify barriers of medications that are safe, effective, and reliably laboratory efficiency. Linking effective levers to these produced at a high level of quality. However, despite areas enables the company to achieve the overall its bottleneck position the quality control laboratory goal to ensure on-time product release and to timely was widely disregarded by pharma companies in provide medication to the patient. Derived from the their operational excellence programs in the past. benchmarking pilot started in 2016 we will present Consequently, efficiency has not been the center of insights with a focus on efficiency drivers in a quality interest in quality control laboratories. control laboratory.

In the recent past laboratory efficiency gained Workshop “Does smart lab system implementation support the attention as one of the key focus area of operational efficiency?” will be one question we want to answer. excellence practitioners. To address the importance Digital Convergence 2020 Roadmap for

21 Paperless Lab Academy® 2017 Keynote DAY 1. 13:40-14:25

Exploring the digital potential for laboratory of the future

name Michael Shanler company Gartner

job title Research Vice President (Industry Analyst) email [email protected]

website www.gartner.com

What is your organization’s “digital potential”? Why devices, as well as better predictive technologies is “digital” essential for your organization to survive across an ever expanding and increasingly complex in the future? Developing an unparalleled situational sets of data will require a shift in thinking and an awareness for laboratory activities as it relates to IT-business realignment. In this session we will innovation, quality, and operational effectiveness explore “Lab of the Future” concepts as well possible will become expectations in the coming years. New “business moments” at the intersection of laboratory capabilities for real time access to data, IoT-enabled staff, business systems and things. Digital Convergence 2020 Roadmap for

22 Paperless Lab Academy® 2017 Presentation DAY 1. 14:25-14:45 Welcome DAMAS - Data Acquisition, Management and Analysis System - an integrated Electronic Lab Notebook @ work Content

name Georg Pollinger

company Roche Diagnostics

job title Business Process Owner DAMAS DSP

email [email protected] Program

website www.roche.com

The process development at biopharmaceutical substance preparation and sample management companies is facing various challenges concerning with linked equipment. DAMAS covers the complete the acquisition, management and analysis of complex experimental chain of process development from data. The quality requirements are rising continuously planning through experimentation, documentation Presentation as well as the complexity of experiments. and data evaluation in a fully electronic manner. This presentation focuses on the challenges and benefits As part of a strategic initiative Roche developed of going paperless in the process development a validated system called DAMAS that merges an environment where finding the right balance between electronic lab journal with material management/ usability and flexibility is a top priority. Workshop Digital Convergence 2020 Roadmap for

23 Transform YOUR BUSINESS WITH Scientific Informatics ● Laboratory Information Management Systems (LIMS) ● Electronic Laboratory Notebooks (ELN) ● Scientific Data Management Systems (SDMS) ● Chromatography Data Systems (CDS) ● Laboratory instruments ● Analytics

Management Consulting – Configuration – VENDOR- NEUTRAL Validation – Deployment Integration – CONSULTING Data Migration – Support Outsourcing

SCIENTIFIC INFORMATICS www.labanswer.com Paperless Lab Academy® 2017 Presentation DAY 1. 14:45-15:05 Welcome Transformational solutions start with a comprehensive data strategy Content name Patrick Pijanowski company LabAnswer

job title Partner, Pharma SCIENTIFIC INFORMATICS & Life Sciences Practice email [email protected]

website www.labanswer.com Program

Transformational business initiatives, especially be readily found, aggregated, interpreted in context, those associated with scientific data and operations, and extracted in an actionable format. Common must be built upon the solid foundation of a oversights like the failure to establish a consistent comprehensive data strategy. The promises of big data taxonomy, inattention to systems architecture, or data, predictive analytics, in-silico modelling, and absence of a culture that treats data as a corporate

quality by design are all wholly dependent upon data asset are often the difference between the success Presentation strategy. As practitioners of scientific informatics, and failure of mission-critical IT programs. The we must remember that what we do is “first and speaker will share insights and best practices foremost, a human endeavour.” Business benefit regarding how to realize the promise of your scientific can only be derived from IT investments if data can informatics investments. Workshop Digital Convergence 2020 Roadmap for

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ELN: ELN: ELN: ELN: Electronic ElectronicELN: ELN: ElectronicELN: ELN: ElectronicELN: ELN: ELN:ELN: Electronic Electronic Electronic Electronic Electronic Electronic Laboratory Electronic ElectronicLaboratory Laboratory Laboratory Laboratory Laboratory Laboratory Laboratory Laboratory Laboratory Laboratory LaboratoryNotebook Notebook Notebook Notebook Notebook Notebook Notebook Notebook Notebook Notebook NotebookNotebook www.agilab.comwww.agilab.comwww.agilab.comwww.agilab.comwww.agilab.comwww.agilab.comwww.agilab.comwww.agilab.comwww.agilab.comwww.agilab.comwww.agilab.comwww.agilab.com LIMS:LIMS:LIMS:LIMS: Laboratory LIMS:LaboratoryLIMS: LIMS:LaboratoryLIMS:LIMS: LIMS:LaboratoryLIMS:LIMS: Laboratory Laboratory Laboratory Laboratory Laboratory Laboratory LaboratoryLaboratoryInformation Information Information Information Information Information Information Information Information Information InformationInformation Management Management Management Management Management Management Management Management Management Management ManagementManagement System System System System System System System System System System SystemSystem 1A 1B 1C 1D

Paperless Lab Academy® 2017 Workshop session 1A DAY 1. 15:50-16:50 Push the limits of your lab Welcome ProLab, a unique and innovative module for project traceability and system validation Content name Mohamed-J. Ndiaye company Agilab job title Chief Research Officer email [email protected] website www.agilab.com Program

Objectives will demonstrate the significant benefits gained by organizations using this unique paperless approach Traditional laboratory software implementation and for project management and system validation. validation is a time consuming and costly paper based AGILAB SCIENCE process that can be plagued with traceability errors Session learnings and risks. Paper-based computer system validation Workshop attendees will learn how to improve requires users to dedicate a large amount of effort

deployment efficiency, reduce project cost and Presentation to create and maintain requirements, define test increase the likelihood of project success by: Optimize your laboratory management with our LIMS and ELN protocols and perform test execution. eeReducing implementation and configuration project applications specialized in Biology, Chemistry, Formulation, ProLab, the project and validation management risk Microbiology and Quality Control. module from AgiLab Science platform, enables a 100% paperless and automated process from eeFacilitating collaboration & project management implementation to validation. ProLab manages eeSimplification of user requirements capture to everything from system and user requirements, delivery specifications, tests feedbacks, qualification protocol Workshop scripts (IQ, OQ, PQ) and data sets, execution result eeReducing validation cycle time and complexity capture, approval and sign off. eeIncreased compliance with tracking protocol  SECURE COMPLIANCE  Using a QC LIMS implementation case study, AgiLab executions and approvals

 MODULAR TRACEABILITY

 USER-FRIENDLY PRODUCTIVITY Digital Convergence 2020 Roadmap for

 NO LEGACY FAST ROI

ELN: Electronic Laboratory Notebook 27 www.agilab.com LIMS: Laboratory Information Management System FOTOS MALA CALIDAD

plantex supports Pharma and Health-care companies in the transformation of complex business, process and critical quality data into actionable insights.

plantex a holistic approach to plantex drastically cuts-back-time tactical and strategic business necessary to understand and verify information the critical process parameters and the effect on critical quality plantex is a digital technology attributes. platform and SaaS data science application. Designed to collect all the relevant process and quality data such as people, production, processes, equipment, raw- materials and environment CRITICAL INFORMATION DATA SCIENCE ensuring constant product quality. DISCOVERY plantex offers a new approach for statistical analysis, linear optimization, method development and validation. DIGITAL DATA VISUAL CONVERGENCE plantex provides business management with advanced planning, modeling (forecast, optimization, predictive) and plantex developed for tactical and visualization tools. strategical business information

We provide your business with new perspectives, helping you make well- informed decisions in complex and challenging situations combining problem-solving and decision-making strategies.

www.spcon.de Copyright Ó Spreitzenbarth consultants GmbH. All rights reserved 1A 1B 1C 1D

Paperless Lab Academy® 2017 Workshop session 1B DAY 1. 15:50-16:50 Welcome Digital data convergence, regulatory audit support and the development of PAT and QbD Content name Marc Vorderman and SPCON Team company Spreitzenbarth Consultants job title Chief Commercial Officer email [email protected] website www.spcon.de/en Program

Objectives feature using collaboration tools such as chat and decision boards, visual collaboration (video) and the For pharmaceutical and health-care companies the backup of all decision data. These so-called decision ultimate objective is the real-time release of products snapshots can be used for regulatory audit support through the design and development of processes and retrieved for (future) reference and verification. that can consistently ensure a predefined quality output. Plantex can drastically cut back the time necessary to understand and verify the critical process parameters Presentation Plantex is a digital technology platform and SaaS data and the effect on critical quality attributes. Plantex science application allowing for a holistic approach to will speed-up the development of- or the continues necessary and critical process and quality data. improvement of an existing- Process Analytical Information taking into consideration all the relevant Technology (PAT) system and/or Quality by Design process and quality data from various data sources. (QbD) framework. Data related to people, production, processes, equipment, raw-materials, CRO’s, CMO’s and Session learnings environment. Including performance attributes of eeWorkshop attendees will learn how to transform Workshop equipment (calibration), in-process resources and complex data into actionable knowledge to create processes ensuring constant product quality. tangible and profitable business actions. Effectively Plantex functions and features is a new approach for utilizing these data and the same time gaining statistical analysis, method verification and method quick and real-time insight into important cross- development. Plantex will also provide business function business and quality information. management with advanced planning and modeling eeWe provide you with new perspectives that help (forecast, optimization, predictive) tools. you in making complex decisions in challenging Decision management support is a fully integrated situations combining problem-solving and decision-making strategies. Digital Convergence 2020 Roadmap for

29 1A 1B 1C 1D

Paperless Lab Academy® 2017 Workshop session 1C DAY 1. 15:50-16:50

NevisData: Hardware-cloud software hybrid solution or how to control the variable that affects the results

name Àlvar Cuevas I Fajardo company Instrumentos Científicos S.A. (ICSA)

job title Project Manager (Lab Consultant & Lims) email [email protected] website www.icsa.es/en

Objectives are basic to see the big picture in the operation of the entire laboratory process. Nowadays the laboratories that have already computerized their processes are unable to Session learnings automatically record, store and associate to the eeImportance for the lab of registering systematically samples the time/location data (collection, delivery all the key parameters of the samples to be and waypoints) and environmental data (temperature analyzed from the pre-sampling to the discard of and humidity normally) of the specimens to analyze the sample. during the periods of transport, storage, conditioning, processing and sampling. These data, which do not eeSolutions to perform the control and link between correspond to the analytical results, are important the time and environmental parameters and the in the final phase of the laboratory process because samples to be analyzed within LIMS software. they can affect the quality and accuracy of these and Digital Convergence 2020 Roadmap for

30 1A 1B 1C 1D

Paperless Lab Academy® 2017 Workshop session 1D DAY 1. 15:50-16:50 Welcome Present and future collaborative innovations within drug discovery informatics Content

name Kellan Gregory company Collaborative Drug Discovery job title Director of Product Excellence email Program website www.collaborativedrug.com/cdd-vault

Objectives Together, we will explore the future of successful scientific collaborations. Collaborative Drug Discovery’s CDD Vault software (Activity & Registration, Visualization, Inventory, Session learnings and ELN) provides an easy and secure way for

eeExperience how collaborative technologies apply to Presentation the collaborative sharing of research data and drug discovery project teams. workflows. Web-based platforms are a natural fit for collaborations due to the economic, architectural, and eeLearn to interactively mine data for hits, outliers design benefits of a single platform that transcends and relationships. any one organization’s requirements. Additionally, eeView cross discipline results that highlight futuristic collaborative drug discovery informatics structure-activity relationships. innovations (such as open-source descriptors, models, and BioAssay Express) are used not only eeUnderstand how to add and generate summary within CDD Vault, but also with other commercial-, information, normalized activity, and compound Workshop academic-, or community-built software tools. selectivity. Digital Convergence 2020 Roadmap for

31

LABWARE 7 LIMS and ELN together in a single integrated software platform. A laboratory automation solution for the entire enterprise.

Offices worldwide supporting customers in more than 100 countries

www.labware.com 2A 2B 2C 2D

Paperless Lab Academy® 2017 Workshop session 2A DAY 1. 17:00-18:00 Welcome Data integrity - How will the new DI regulations affect your organization Content name Mark Gonzalez company LabWare job title Technical Director email [email protected] website www.labware.com Program

Objectives Session learnings The workshop will discuss the current directives eeWhat action to take with regards to data integrity and how the possible eeHow to adapt to the new regulations regulation could affect scientific information systems for capturing all data at source. LabWare will also eeHow to plan for the new DI regulations. outline their strategic approach and present solutions to address the possible regulations. Presentation Workshop Digital Convergence 2020 Roadmap for

35 Pharma&Biotech

ThePharma&Biotech MODA™ Platform The Missing Piece in Your Lab Systems Portfolio

The MODA™ Platform The Missing Piece in Your Lab Systems Portfolio

MODA-EM™ for QC Micro – Implement, Validate, Integrate Seamlessly.

Lonza’s MODA-EM™ is a purpose-built informatics platform for QC Micro- – Reduce investigation and reporting time with rapid analysis biology’s unique challenges. MODA™ delivers better business alignment and visualization of Micro data with QC, at a lower total cost of ownership versus customizing your – Manage, schedule and track large EM and utility sample volumes existing LIMS or other lab systems. – Eliminate errors while improving compliance and data integrity – Deliver measurable return on investment from time, cost and Learn how MODA™ can fill the missing piece in your lab system portfolio, compliance savings visit www.lonza.com/moda or contact us at [email protected] MODA-EM™ for QC Micro – Implement, Validate, Integrate Seamlessly.

©Lonza’s 2015 Lonza MODA-EM™ is a purpose-built informatics platform for QC Micro- – Reduce investigation and reportingwww.lonza.com/moda time with rapid analysis biology’s unique challenges. MODA™ delivers better business alignment and visualization of Micro data with QC, at a lower total cost of ownership versus customizing your – Manage, schedule and track large EM and utility sample volumes existing LIMS or other lab systems. – Eliminate errors while improving compliance and data integrity – Deliver measurable return on investment from time, cost and Learn how MODA™ can fill the missing piece in your lab system portfolio, compliance savings visit www.lonza.com/moda or contact us at [email protected]

© 2015 Lonza www.lonza.com/moda 2A 2B 2C 2D

Paperless Lab Academy® 2017 Workshop session 2B DAY 1. 17:00-18:00 Welcome Building a better business case

name Robert Lutskus

company Lonza Content

job title Global product Delivery Manager - Informatics email [email protected] website www.lonza.com

Objectives Session learnings Program Transitioning from a paper based or legacy electronic eeAttendees will learn about the process and tools system requires multiple levels of approval from available to develop a business case an organization. The process of justifying the cost, eeAttendees will see examples of successful selecting the right system and ensuring the approval business cases used in the justification of MODA of your project is tied to the business case you can EM, a best in class enterprise Environmental develop to support it. This session will discuss the Monitoring Software approaches to the business case, how to ensure the data backs up any assumptions and selecting Presentation the system that fits the needs set forth by the organizations. Workshop Digital Convergence 2020 Roadmap for

37 You can focus on your science, we’ll get smart with the software… Meet The E-WorkBook Cloud

All the power of E-WorkBook, now in the Cloud The IDBS E-WorkBook Cloud is a single platform that will change the way your lab works, forever. It takes the traditional paper-based lab approach and makes it smarter. A whole lot smarter. It gives you the ability to easily handle your R&D data management, work planning, scheduling, workflow execution, decision support and compliance needs, with a simple, integrated web-based tool. With The E-WorkBook Cloud, you can get back to doing what you do best: science.

For more information, visit: www.idbs.com 2A 2B 2C 2D

Paperless Lab Academy® 2017 Workshop session 2C DAY 1. 17:00-18:00 Welcome Lessons learned and things to remember when migrating from on premise to cloud Content name Paul Deny Gouldson company IDBS job title Vice President, Strategic Solutions email [email protected] website www.idbs.com Program

Objectives We will go over how a number of these hurdles can be identified and managed, using various use cases of Many companies are migrating their on premise IT IDBS moving customers from on prem to The Cloud. infrastructures to the cloud, to take advantage of lower costs and better overall support. This journey, however, is not as simple as flicking a switch and everything is there. Many factors impact the speed Session learnings and stages that a migration should go through. They eeWhat are the starting list of barriers and solutions Presentation include, but are not limited to: when moving to IT systems eeApplication design and support for web eeUsing case studies see how others have accomplished the move eeValidation of systems eeAn opportunity to discuss real world issues with eeIntegrations to other cloud and on premise your peers. systems

eeSecurity of , data and users Workshop eeIT policies Digital Convergence 2020 Roadmap for

39 The Internet-of-Things tailored to your lab.

Explore the opportunities! Join our workshop at the #PLA2017 cubuslab provides IoT-solutions specifi cally designed for the requirements of laboratories. We enable you to complete work faster at higher quality thereby giving you space for passion and curiosity. Focusing on a holistic approach, we integrate your devices independent of the vendor and give you the felxibility to connect your third party systems like LIMS, ELN or CDS.

www.cubuslab.com | [email protected] | +49 721 754 039 48 2A 2B 2C 2D

Paperless Lab Academy® 2017 Workshop session 2D DAY 1. 17:00-18:00 Welcome Why an IoT-platform is essential for a sustainable digitization of laboratory processes Content name Dr. Dominic Lütjohann company cubuslab GmbH job title Chief Executive Officer, co-founder email [email protected] website www.cubuslab.com/en Program

Objectives Session learnings In laboratories worldwide, a growing number of In this workshop, attendees will learn how flexible processes are being digitalized to improve and and easy an IoT-Platform can solve the challenges accelerate daily laboratory work: documenting and of transforming current processes into digital, transferring process data and experiment results connected lab workflows. From the very beginning, from multiple devices to ELN, LIMS or CDS system. the gains are visible: higher quality of documentation and reduced efforts which directly turn into savings Presentation Current approaches of device integration into for businesses. workflows usually lack one or more crucial requirements: compatibility, scalability, ease-of- eeAn IoT platform provides real-time data for use for scientists, or the integration depth with improved quality and automated documentation existing systems, especially in large scale enterprise eeAn IoT platform allows enterprises to achieve scenarios or the cloud. holistic data integrity throughout lab processes Only an easy to use, vendor-neutral IoT platform, eeAn IoT platform seamlessly connects devices, which connects all laboratory devices in a unified way Workshop people and data. can tackle this challenge, and enables researchers to virtually access all their relevant data from anywhere at any time. Digital Convergence 2020 Roadmap for

41 LABWARE

LIMS and ELN together in a single integrated software platform. A laboratory automation solution for the entire enterprise.

Offices worldwide supporting customers in more than 100 countries www.labware.com SPECTRA ANALYSE LA REVUE DES SCIENCES ANALYTIQUES

La revue de référence des laboratoires de sciences analytiques

SPECTRA ANALYSE SPECTRA ANALYSE SPECTRA ANALYSE LA REVUE DES SCIENCES ANALYTIQUES LA REVUE DES SCIENCES ANALYTIQUES LA REVUE DES SCIENCES ANALYTIQUES . . N° 313 DÉCEMBRE 2016 30 N° 312 . NOVEMBRE 2016 . 30 € N° 311 . SEPTEMBRE - OCTOBRE 2016 . 30 € Analyse Informatique Protéomique & des momies métabolomique de laboratoire • Imagerie des momies • Approche médico-légale • Caractérisation fi ne de protéines • TABLEAU SYNOPTIQUE et anthropologique thérapeutiques à l’aide du couplage électrophorèse capillaire/spectrométrie LIMS et ELN présents par imagerie 3D de masse sur le marché français • Datation par le carbone 14 • Authentifi cation d’extraits naturels • Datation par Résonance de parfums et d’arômes Paramagnétique Électronique • MÉTROLOGIE par la métabolomique • Spectrométrie de masse Traçabilité des mesures • Analyse protéomique physico-chimiques • Synoptique : Caractéristiques techniques des cheveux de momies des instruments LC/MS d’entrée de gamme • ADN disponibles sur le marché français

SPECTRA ANALYSE SPECTRA ANALYSE SPECTRA ANALYSE LA REVUE DES SCIENCES ANALYTIQUES LA REVUE DES SCIENCES ANALYTIQUES LA REVUE DES SCIENCES ANALYTIQUES N° 310 . JUIN - JUILLET 2016 . 30 € . . € N° 309 AVRIL - MAI 2016 30 N° 308 . JANVIER - FÉVRIER - MARS 2016 . 30 €

Caractérisation radiologique transportable • Développement d’un laboratoire mobile pour la caractérisation radiologique des sols et des structures de sites en assainissement • Réhabilitation des sols sur un site nucléaire en démantèlement

• Interprétation automatique des spectres de RMN de petites molécules organiques en solution : principe et exemples • La RMN à répétition rapide : gagner du temps pour une meilleure sensibilité

• NUMERO SPECIAL FORUM LABO & BIOTECHS

Métrologie dans le domaine micro-nano

• Métrologie pour les dispositifs • Conception d’un système portable médicaux de perfusion pour l’étalonnage des instruments de mesure de concentration massique particulaire dans l’air ambiant • Stabilité des principaux composants des e-cigarettes testés par analyse thermique (ATD-ATG) • Projet NANOMET : développement de protocoles de référence pour accompagner la mise en place d’une caractérisation Spécial dopage sportif métrologique des nanomatériaux au sein des PME

• L’informatisation à l’Agence Française • Détermination des bêta-bloquants dans l’urine de Lutte contre le Dopage par chromatographie en fl uide supercritique • Évolutions dans la détection du dopage sanguin • Stratégies analytiques pour les contrôles • La RMN : un excellent outil pour la caractérisation antidopage : besoins, challenges et perspectives structurale et dynamique des agrégats organolithiés

PRESSE Communication International www.pcipresse.com – www.spectraanalyse.com PCI • Presse Communication International • 176, rue du Temple • 75003 Paris • Tél : +33 (0)1 44 59 38 38 ® Program Paperless Lab Academy 2017

DAY 2 - APRIL 5TH

ROBERTO CASTELNOVO Chairman’s welcoming address 2nd day MANAGEMENT Event organizer / Founder at CONSULTING 08:30 - 09:00 Making the Complex Simple Results of international ELN survey NL42

Keynote: IoLT and information governance: understanding and SOFIE V.D. MEULEN 09:00 - 09:30 attacking the business, technical and Attorney at Law legal issues

Workshop elevator pitches 09:30 - 09:45 Introduction to workshops of sessions III, IV & V

3A. How to use your lab data for STEPHANE VELLAY tech transfer and better decision Lead Field Application Scientist making

3B. A platform and application JEFF NOONAN approach to genomics and Vice President, Business Development WORKSHOP 3 biologics R&D

3C. How data integrity elements 09:50 - 10:50 & aspects are audited during inspections (customer audit OSCAR KOX presented by customer) and how an Business Development integrated lab automation platform, Manager LES (LIMS & ELN) accommodates these elements/aspects

3D. Improve your lab maturity DR. ERIC LITTLE with data science Vice President Data Science

10:50 - 10:20 COFFEE BREAK

4A. Improving data integrity with end- DR. DIETER GENSKE to-end integration of ERP, LES, Senior Consultant LIMS and analytical instruments BURKHARD SCHAEFER with the AnIML data standard President

4B. Data integrity?: How to get the most out of your Empower data; DOMINIQUE AGRO WORKSHOP 4 Sales Development have secured your MS Excel

Digital Convergence ARJAN TIMMERMAN spreadsheets; and archived all

2020 Roadmap for Technical Business Development 11:25 - 12:25 your electronic data! 4C. Dealing with a lot of paperwork? Learn how laboratory informatics GORDON LORIMER simplifies the complexity of General Manager EMEA compliance data integrity

4D. Collaboration to insight: PATRICK ANSEMS Closing the gap between data Director, EMEA Field capture and real time decisions Applications Science 44 ® Program Paperless Lab Academy 2017 Welcome

DAY 2 - APRIL 5TH

5A. Unlock the value of your data with integrated lab and data CRISTINA ROMAN management combined with Senior Business Consultant

cloud capabilities Content

5B. An integrated lab informatics DR. ROB BROWN Vice President Product WORKSHOP 5 workflow for antibody discovery Marketing

5C. Eliminate the laboratory process 12:30 - 13:30 pains & enhance compliance assurance. Through electronic EDDIE RYAN

lab validation enabling significant Chief Executive Officer Program productivity gains, cycle time improvements and resource savings 5C. Data governance: Answering the ALCOA-based data integrity and GUNNAR DANIELSON Global Software Solutions data quality topics and to the Manager lifecycle of your data

13:30 - 14:30 LUNCH Presentation

Practical approaches for an effective KURT IN ALBON 14:30 - 14:50 Director Global Quality data governance program Assurance

Version control: The software KATRIN LEINWEBER 14:50 - 15:10 industry's solution to data integrity Process Manager Paperless Lab

problems Workshop

Management of research data in academia: development of a modern DR. NICOLE JUNG 15:10 - 15:30 research infrastructure with open Research manager source software

Internet of Laboratory Things – Visualizing your data and yielding ROSS EMERTON 15:30 - 15:50 important results without an army of Vice President / Chief Architect data scientists

15:50 - 16:00 CLOSING Digital Convergence 2020 Roadmap for

45 MANAGEMENT CONSULTING

Making The Complex Simple

Paperless Projects

Objectives and requirements definitions: business, users and technical needs

“As is” and gap analysis

Business process reengineering & KPI definitions

Provider selection and SWOT analysis

IT strategies for systems consolidation, harmonization and integration

Quality expertise from URS to final CSV.

www.NL42.com ® Welcome Paperless Lab Academy 2017 Welcome Chairman’s welcoming address

name Roberto Castelnovo

company NL42 Consulting Content MANAGEMENT CONSULTING job title Making the Complex Simple Founder & Owner

email [email protected]

website www.NL42.com Program On this second day, we’ll continue framing our In collaboration with Scientific Computing World, we roadmap and seeking for ideas on how to adopt best have launched an International Electronic Laboratory practices in our daily work. The additional 3 series of Notebook Survey. We are looking for your assessment workshops will provide further information on what’s on the use of ELN in your lab whether you have an available in the market. ELN in your lab, planning to get one or not. Action of the day is to collect all remaining pieces A summary of the results obtained from this survey to build the puzzle to visualize the future of our will be presented in this second day welcome talk. laboratory and how should the data flow in the Presentation company to generate valuable insight. Workshop Digital Convergence 2020 Roadmap for

47 Il portale dell’industria chimica www.industrychemistry.com

Il portale del laboratorio www.labworld.it

Editrice Industriale - Centro Direzionale Milanofiori - Palazzo Q8 Strada 4, 20089 Rozzano (MI) Italia Tel: +39 02 3032181 - Fax: +39 02 303218500 - [email protected] - www.editriceindustriale.it Paperless Lab Academy® 2017 Keynote DAY 2. 09:00 - 09:30 Welcome IoLT and information governance: understanding and attacking the business, technical and legal issues Content

name Sofie v.d. Meulen

company Axon Lawyers

job title Attorney at Law Program email sofie.vandermeulen@axonlawyerscom

website www.axonlawyers.com

Introducing IoT in your laboratory environment makes ensure the accuracy and integrity of the collected manual monitoring of equipment a thing of the past (personal) data and to protect the data against loss, as a large number of sensors, of example to measure alteration or theft? And what about cyber security? temperature and humidity, can be connected. The Presentation Non-compliance with cyber security requirements data of various sensors from multiple labs can be can give rise to potentially high administrative fines directly uploaded to a cloud server from where other and damage to (the reputation of) your business. This collaborating laboratories can read, analyze, and and more will be discussed. store the data. The benefits are plenty. But how to Workshop Digital Convergence 2020 Roadmap for

49 BIOVIA Unified Lab Management Complimentary white paper available at: 3dsBIOVIA.com/DigitalLab

BIOVIA UNIFIED LAB MANAGEMENT Integrating and standardizing data, resources and processes in research, development and quality labs to improve operational excellence, collaboration and time-to-market

The BIOVIA Unified Lab Management suite is a comprehensive software offering that optimizes operations, maximizes quality and drives innovation. As a collection of standardized solutions built on a single unifying technology foundation, the BIOVIA Unified Lab Management suite provides unique, role-based user experiences for the lab.

BENEFITS CUSTOMER VALUE To learn more about Reported customer benefits of BIOVIA’s • Design, develop, characterize and BIOVIA Unified Lab Unified Lab Management capabilities are: release products more effectively at • 30% reduction in errors and reworks reduced costs with data driven Management, visit: processes • 25% improvement in quality • Improve collaboration, innovation and • 25% improvement in regulatory decision making through easier 3dsBIOVIA.com/DigitalLab compliance exchange of more consistent data and • 35% reduction in review times information • 40% reduction in audit and report time • Increase Right First Time through standardization and improved • 50% decrease in cycle times compliance with procedures and • 25% improvement in productivity policies supporting quality and regulatory initiatives 3A 3B 3C 3D

Paperless Lab Academy® 2017 Workshop session 3A DAY 2. 09:50 -10:50 Welcome How to use your lab data for tech transfer and better decision making Content name Stephane Vellay company Dassault Systèmes Biovia job title Lead Field Application Scientist email [email protected]

website www.3ds.com/products-services/ biovia Program

Objectives Session learnings The lab creates an abundance of data that is of great See how: value to organizations for improving the quality of eeYour current lab data can be leveraged in an processes and products. In many organizations the automated way for better process and product access, aggregation and contextualization of data insights still requires significant effort. These tasks are non-value adding and prevent staff from focusing on eeYou can improve process design by identifying the Presentation science and decision making. When data is used for critical process drivers making GMP relevant decisions, proofing data quality eelate development can transfer knowledge with and integrity can be an issue. The integration of the manufacturing validation-ready BIOVIA Discoverant solution with Lab Informatics systems reduces time consuming eelaboratory and manufacturing data can be and error-prone work and delivers insightful reports gathered on demand and contextualised with the such as, stability reporting, without the need for data process itself. duplication. Depending on time and number of attendees, live Workshop demo may be replaced by an interactive hands-on session. Digital Convergence 2020 Roadmap for

51 3A 3B 3C 3D

Paperless Lab Academy® 2017 Workshop session 3B DAY 2. 09:50 -10:50

A platform and application approach to genomics and biologics R&D

name Jeff Noonan company Core Informatics job title Vice President, Business Development email [email protected] website www.coreinformatics.com

Objectives Session learnings Implementing genomics and biopharma R&D eeOverview of the NGS and Sanger sequencing app software can be challenging and time consuming. solutions that enable genomics data tracking from This workshop will describe how pre-built sample accessioning through sequencing applications from the Platform for Science eeOverview of biologics app solutions which support a Marketplace can simplify the implementation of these variety of biopharma R&D processes including, but workflows. The apps from this rapidly expanding not limited to, registration, screening, cell culture, ecosystem benefit from capabilities of Core’s and inventory management. Platform for Science, including Core Connect, which streamlines platform integration with other software eeOverview of Core Informatics’ latest product Core systems (via a standards-based API). Connect. Digital Convergence 2020 Roadmap for

52 3A 3B 3C 3D

Paperless Lab Academy® 2017 Workshop session 3C DAY 2. 09:50 -10:50 Welcome How data integrity elements & aspects are audited during inspections Content name Oscar Kox company iVention job title Business Development Manager email [email protected] website www.ivention.nl Program

Objectives execution functionality to support a complete lab automation process and how this is audited by a top 3 The workshop provides a platform to discuss the pharmaceutical company. regulatory focus with regards to Data Integrity. Delegates will get inside information from a large The workshop will have the following additional pre-clinical organization using a cloud based lab content: automation platform (iLES) about a recent audit eeGAMP Auditor, Mr. Frans Leijse, will explain the Presentation by one of the top 3 pharma to be granted a large impact of the new ruling and audits regarding data contract. How can a Lab Execution System, one integrity integrated cloud based platform with LIMS, ELN, LES and (S)DMS functionality provide the premise for eeLarge pre-clinical CRO will present a recent audit these audits. A new approach in lab automation vs on their lab automation platform the classic implementations. The workshop includes eeSalesforce will attend this workshop as “special functional demonstrations. supporting guest” on cloud systems for life science

Session learnings eeiVention will present unique functional areas of the Workshop iLES cloud lab automation platform. Workshop attendees will learn how to use a cloud based execution platform with LIMS, ELN and Digital Convergence 2020 Roadmap for

53 Paperless Lab Academy® 2017 Barcelona, April 4th & 5th

PLA2017 Satisfaction survey

YOUR OPINION IS IMPORTANT FOR US Share your views on the event! bit.ly/PLA20172lGvZJ6 3A 3B 3C 3D

Paperless Lab Academy® 2017 Workshop session 3D DAY 2. 09:50 -10:50 Welcome Improve your lab maturity with data science Content name Dr. Eric Little company Osthus job title Vice President Data Science email [email protected] website www.osthus.com Program

Objectives Session learnings We will discuss the move to truly digital laboratories. eeThe current state of laboratory data (paper-to- Currently many labs still rely heavily on paper, or, digital) and trends that show how this data is at best, paper-on-glass approaches, where ELNs changing or other tools provide paper-like data that can be eeWhat is the Internet of Things and how will it utilized more easily and with more control. However,

impact laboratories Presentation the move to purely digital laboratories is the next advancement, driven in part by the Internet of Things. eeWhat we mean by a truly “digital lab” and how to As devices become smarter and produce data about get there themselves, it will become increasingly important eeUnderstanding of semantic technologies and how for scientists to take advantage of more powerful they can help move to a digital lab machines, as well as more powerful data techniques, including: semantic technologies, analytics, machine eeUnderstanding of data analytics and how they can , natural language processing and trending/ help move to a digital lab alerting. eeUnderstanding of what is meant by Big Analysis as Workshop data science. Digital Convergence 2020 Roadmap for

55 iCD - 30 years of expert software for laboratory experts!

Since foundation of iCD. GmbH in 1986 this service-oriented company has doctoral degree in chemistry, physics, computer science and other natural been focusing on consulting services and software development in the sciences, and are experienced in the laboratory and LIMS environment field of technical-scientific data handling and management. since many years. The ability to work in teams is an essential requirement for our staff as the main business of iCD. is to focusing on the realization iCD. is a German company with its headquarter in Frechen-Königsdorf and implementation of often complex software projects. nearby to the city of Cologne. Here the complete application and system development takes place. Products of iCD. are sold world-wide by iCD. Vertriebs GmbH and local partners in foreign countries belonging to the Global Partner Network. www.icd.eu iCD. engages 40 full-time employees as well as a varying number of student assistants. Most of the permanent employees are graduated or have a Info: +49 (22 34) 9 66 34-0 4A 4B 4C 4D

Paperless Lab Academy® 2017 Workshop session 4A DAY 2. 11:25 - 12:25 Welcome Improving data integrity with end-to-end integration of ERP, LES, LIMS and analytical instruments with the AnIML data standard Content

name Dr. Dieter Genske company iCD. Vertriebs GmbH job title Senior Consultant email [email protected] Program website www.icd.eu

name Burkhard Schaefer company BSSN Software GmbH job title President email

[email protected] Presentation website www.bssn-software.com

Objectives Session learnings One of the challenges in laboratory data management Participants will experience first-hand: is integration across systems and across instruments. eehow AnIML can be used to connect multiple Today, most instruments produce data in their own instruments of different using a single interface Workshop proprietary formats. This leads to major difficulties to achieve integration and data integrity. eehow LIMS systems can be connected to ERP systems to achieve an end-to-end integration This workshop demonstrates how vertical interfaces and standard formats such as AnIML can be used to eehow the combination of such integrations and open create an end-to-end integration: A measurement standards can enable full traceability and data order may start at an ERP system (such as SAP), be integrity. orchestrated through a LIMS, passed to instruments eehow AnIML data can be used on the desktop, the for measurement, and reported all the way back up. web and in the cloud. In live sessions, SAP-to-LIMS interfacing, as well as instrument interfacing will be demonstrated. The AnIML format will be used to connect five different instrument types to the system. Digital Convergence 2020 Roadmap for

57 THE POWER OF TWO.

MAXIMIZE YOUR RESULTS.

How do you get more out of your Empower® Chromatography Data Software? Connect with NuGenesis® Lab Management System (LMS), driving enhanced INFORMATICS data management capabilities for sharing, storing, archiving and retrieving AND SOFTWARE chromatographic results across the enterprise. To more effectively manage the life-cycle of your Empower CDS data, visit waters.com/poweroftwo

PHARMACEUTICAL ■ HEALTH SCIENCES ■ FOOD ■ ENVIRONMENTAL ■ CHEMICAL MATERIALS

©2017 Waters Corporation. Waters, Empower, NuGenesis and The Science of What’s Possible are registered trademarks of Waters Corporation.

ThePowerOfTwo A4 advert.indd 1 13/01/2017 11:37

Please note this is a COMMON SIZE mechanical file, you will need to center file using the center marks Job Name: WATR18884_A_PowerOfTwo_2017_DBmec.indd provided when placing ad in the publication page area. (common size = smallest live/smallest trim/largest bleed) SPECS APPROVALS Small Trim: 7.75” X 10.5” PUBS: Food Processing Pharmaceutical Discovery Large Trim: 8.375” X 10.875” AD: PM: American Laboratory Food Quality & Development Food Safety Magazine Pharmaceutical Manufacturing Bleed: 8.625” X 11.375” CW: MK: American Drug Discovery American Pharmaceutical Review Genetic Engineering News (GEN) Pharmaceutical Technology Live: 6.75” X 9.5” CD: PP: Bio Business Genome Technology Pharmaceutical Technology EUROPE Colors: 4C Bio IT World Genomics & Proteomics Pharmaceutical Executive ST: QA: BioTech World Jour of The American Soc for Pharm Form and Quality Scale: 100% BioTechnology Focus Mass Spectrometry Proteomics Journal Other: copyright 2017 QR Code Check iPhone DROID BioPharm International Lab Asia Media Guide Scientific American BioProcess International Lab Business - Jesmar Scientific Computing & Instrumentation LCGC Asia Scientific Computing World RELEASE DATE 01-12-17 Chemical & Engineering News Drug Discovery and Dev LCGC N. America Drug Discovery News LCGC Europe Environmental Science & Technology Molecular and Cellular Protemomics Nature Methods 4A 4B 4C 4D

Paperless Lab Academy® 2017 Workshop session 4B DAY 2. 11:25 - 12:25 Welcome Data integrity? How to get the most out of your Empower data; have secured your MS Excel spreadsheets; and archived all your electronic data! Content

name Dominique Agro company Waters Corporation Sales Development Informatics job title Program Europe & India email [email protected] website www.icd.eu

name Arjan Timmerman company Waters Corporation

job title Technical Business Development Presentation Specialist, Europe & India email [email protected] website www.bssn-software.com

Objectives Session learnings

Everybody has analytical data, how do you get the eeEDS365, extracting Empower data to view and Workshop important information out your Empower database, access your important information and identify the critical information? eeSecurely access and use your MS Excel Securing your MS Excel spreadsheets? What solution spreadsheets, using NuGenesis LMS does Waters provide to help you securely access and eeArchiving your electronic data; vendor independent use your MS Excel spreadsheets? capturing of your printouts and raw data, indexed Archiving your electronic data: Do you follow the and ready for retrieval. guidance in archiving your data? Digital Convergence 2020 Roadmap for

59 One Partner One Powerful Solution Data integrity, accessibility and innovation for lab excellence.

LIMS

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ADVANCED MOBILE ANALYTICS

Visit www.informatics.abbott to learn more. Call us at +34 91 663 67 64 to request a demo.

See where it will take you at informatics.abbott 4A 4B 4C 4D

Paperless Lab Academy® 2017 Workshop session 4C DAY 2. 11:25 - 12:25 Welcome Dealing with a lot of paperwork? Learn how laboratory informatics simplifies the complexity of compliance with data integrity Content

name Gordon Lorimer company Abbott Informatics job title General Manager EMEA email

[email protected] Program website www.informatics.abbott

Objectives Session learnings Industry faces the everyday challenge of managing In this session, Abbott Informatics team will discuss cost efficient operations, producing high quality, safe how laboratory informatics simplifies the complexity products and having visibility of the operations and of compliance with data integrity: Presentation data. Ensuring the cost of quality adds value to the eeLaboratory informatics and why it matters operations, becoming lean, streamlined, improving process and complying with the industry regulations eeAdapting your delivery approach to leverage the are at the top level priorities. power of these trends eeThe importance of data transmission and fidelity, its meaning and effect of the data. Workshop Digital Convergence 2020 Roadmap for

61 ® Workshop session Paperless Lab Academy 2017 is a registered trademark of PerkinElmer, Inc. All other trademarks are the property their respective owners. ®

WHEN DATA CONNECTS, All rights reserved. PerkinElmer YOU CAN TAKE YOUR SCIENCE IN THE RIGHT DIRECTION Copyright © 2017 PerkinElmer, Inc. 400312_15

Informatics Solutions There’s so much great science buried in your data – problem is, TIBCO Spotfi re® much of it remains isolated and undiscovered in Research, in ChemDraw® Clinical, in Manufacturing, in scientists’ lab notebooks themselves.

Digital Convergence Our Informatics solutions connect all your disparate islands of Elements 2020 Roadmap for information through a unique, comprehensive combination of E-Notebook instrument control, scientific-based applications, and enhanced PerkinElmer Signals™ for Translational services – so you can not only manage your data, you can help drive the discovery process. This is how unconnected data becomes PerkinElmer Signals™ for Screening smart data. PerkinElmer Informatics solutions: Because when your

iLAB™ data connects, you can take your science in the right direction.

62 www.perkinelmer.com/informatics 4A 4B 4C 4D

Paperless Lab Academy® 2017 Workshop session 4D DAY 2. 11:25 - 12:25 Welcome Collaboration to insight: Closing the gap between data capture and real time decisions Content

name Patrick Ansems company PerkinElmer

job title Director, EMEA Field Applications Science email [email protected] Program website www.perkinelmer.com/informatics

Objectives Session learnings The promise of electronic lab notebooks has always eeIntroducing our new PerkinElmer Signals been to capture data so that it can be used to make Notebook; learn how this can be used in a better decisions. Fulfilling this promise has been collaborative framework whether you are capturing Presentation a challenge since the same flexibility required to chemistry, biological or formulation data make an ELN system easy to use has made it hard eeHad enough of all the data silos in your to organize the data for decision support. However, organization: We will showcase our Attivio recent advances in Big Data technologies have made technology which connects various data sources it possible to reshape and organize data in ELN and allows you to answer questions you never systems in situ without substantial data warehousing dared to ask before projects. Once in place, the reshaped data is ready- made for exploration, analysis and discovery with eeTo finalize our session we will showcase how that applications like TIBCO Spotfire. information from numerous data systems can be Workshop combined to generate dynamic reports using the TIBCO Spotfire platform. Digital Convergence 2020 Roadmap for

63 Compliance audits simplified Compliance audits simplified With Thermo Scientific Integrated Informatics Solutions

IfWith you’re a complianceThermo officer Scientific or a QA/QC manager Integrated in the pharmaceutical Informatics industry Solutions today, you need confidence that you can locate and retrieve a variety of complex analyticalIf you’re a datacompliance during anyofficer unannounced or a QA/QC or scheduledmanager in regulatorythe pharmaceutical audit. Thermo industry Scientifictoday, you™ SampleManagerneed confidence LIMS that ™you is ancan Integrated locate and Informatics retrieve a Solution,variety of deliveringcomplex analyticallab information data duringmanagement, any unannounced Scientific orData scheduled Management regulatory (SDMS) audit. and Thermo Lab Execution (LES). SampleManager Scientificgives you™ the SampleManager data confidence LIMS you™ isneed an Integrated without the Informatics expense Solution,of multiple delivering software solutions, service agreements andlab information the time spent management, in implementation Scientific and Data validation. Management (SDMS) and Lab Execution (LES). SampleManager gives you the data confidence you need without the expense of multiple software solutions, service agreements andWith the SampleManager time spent in implementationLIMS, your most and valuable validation. laboratory asset – your data – is secure, future-proofed and archived for whenever you need it Withand you SampleManager can rest assured LIMS, you’ll your be most Audit valuable Ready. laboratory asset – your data – is secure, future-proofed and archived for whenever you need it Findand you out can more rest assured at thermoscientific.com/RestAssured you’ll be Audit Ready. Find out more at thermoscientific.com/RestAssured © 2017 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.

© 2017 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. 5A 5B 5C 5D

Paperless Lab Academy® 2017 Workshop session 5A DAY 2. 12:30 - 13:30 Welcome Unlock the value of your data with integrated lab and data management combined with cloud capabilities Content

name Cristina Roman company Thermo Fisher Scientific job title Senior Business Consultant email [email protected] website www.thermofisher.com Program

name David Joyce company Thermo Fisher Scientific

job title Senior Product Manager, Emerging Technologies

email [email protected] Presentation website www.thermofisher.com

Objectives Session learnings Thermo Fisher Scientific provides a complete eeDiscover a complete lab software solution integrated lab & data management solution, comprising LIMS, CDS, SDMS, and LES (Procedural comprising LIMS, CDS, SDMS and Procedural ELN). Workshop ELN. This workshop will discuss the importance of Understand the benefits of such an integrated these multiple capabilities, explore the benefits of a solution: complete, integrated solution and demonstrate some common workflow examples. eeIncreased efficiencies and automation through secure data and information transfer IOT, cloud computing and mobile solutions are becoming commonplace in today’s homes - we will eeReduced costs and risks from deploying a complete show how Thermo Fisher applies these technologies single vendor solution to enable a smarter lab. eeAchieve secure, mobile access to data and instruments via Thermo Fisher Cloud. Digital Convergence 2020 Roadmap for

65 Presentation 13 DAY 2. 14:30 -14:50

Bridging business and IT to deliver adapted and stable solutions and services for the complex business or technical challenges of our

customers.

With more than 20 years experience of delivering effective solutions, we have established ourselves as a quality service provider for the Life Science industry. 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 services and solving complex issues. Requirement Analysis | Vendor Assessments | Project Realization Computerized System Validation | Continuous Lifecycle Assistance

wega Informatik AG | Aeschengraben 20 | CH - 4051 Basel | Tel.: +41 61 270 87 87 | [email protected] | www.wega-it.com

Paperless Lab Academy® 2017 Barcelona, April 4th & 5th

PLA2017 Satisfaction survey

YOUR OPINION IS IMPORTANT FOR US Share your views on the event! bit.ly/PLA20172lGvZJ6 5A 5B 5C 5D

Paperless Lab Academy® 2017 Workshop session 5B DAY 2. 12:30 - 13:30 Welcome An integrated lab informatics workflow for antibody discovery Content name Dr. Rob Brown company Dotmatics Ltd job title Vice President Product Marketing email [email protected] website www.dotmatics.com Program

Objectives Studies Notebook and Bio Register to capture experiments, processes, entities and tests. Antibodies have become an important and growing part of the discovery portfolio of many companies. Session learnings However, the informatics systems that are used to Participants will be able to: capture the experiments and associated results are often fragmented and involve manual process. eeSee the value of an integrated antibody workflow. Presentation In this workshop we will demonstrate the use of eeUnderstand how this can be configured to their the Dotmatics solution for antibody discovery that organization’s process and environment. provides a fully integrated workflow that uses the Workshop Digital Convergence 2020 Roadmap for

67 Kneat Software Validation Lifecycle Management

Optimize Validation & GxP Testing Processes Globally

End-to-end paperless

Increase Productivity by 100%

Cut Cycle Times by 50%

Cut Resource Time by 50 - 80%

Easy to Deploy

Easy to Use

Easy to Scale

Validation Lifecycle Management

Email: [email protected] Phone: +353 61 203826

Kneat advert A4 Design - Brainstorm 2.indd 1 30/01/2017 19:50 5A 5B 5C 5D

Paperless Lab Academy® 2017 Workshop session 5C DAY 2. 12:30 - 13:30 Welcome Eliminate the laboratory process pains & enhance compliance assurance Content name Eddie Ryan company Kneat Solutions Ltd. job title Chief Executive Officer email [email protected] website www.kneat.com Program

Objectives eeLimited visibility both globally and across sites Increasing levels of validation activities and higher eeData integrity concerns i.e. ALCOA principles. regulatory expectations across laboratory processes are increasing the demand for compliant validation services. Session learnings The laboratory process for equipment management Using an actual client example the workshop will Presentation and status tracking is a manual paper based process, explain: with the following issues: eeFrom existing paper to a future e-validation eeHigh level of effort/ time to create, execute and solution and the steps to justify, plan implement a maintain lab validation records i.e. requirements, lab e-validation system protocols, test scripts, risk assessments, trace eeStreamline and structured process to identify/ matrices track/ quality new equipment. eeCross lab and cross sites inconsistences

eeComprehensive dashboard with visibility to real- Workshop eeNo real time viewable lab equipment/ systems time data for lab equipment & systems status index eeAbility to share and leverage information across eeNo standardized/ structured new equipment labs/ sites process templates/ workflows eeEnsure compliance with data integrity eeNo efficient process to leverage previous requirements information for current tasks eeProvide easy controlled lab records e-access and eeNo best practice across projects and sites user friendly metrics eeAccurate Metrics not available eeAbility to verify user training before equipment/ system use. eeCumbersome record storage and retrieval Digital Convergence 2020 Roadmap for

69 Data Governance Begins at the Starting Point

In a typical QC lab, 40% of the benchtop instruments can operate on one instrument software – LabX

"Data should be maintained throughout the record‘s retention period with all associated metadata required to reconstruct the CGMP activity (e.g., §§ 211.188 and 211.194). The relationships between data and their metadata should be preserved in a secure Data Integrity and traceable manner." Data Quality FDA further definitions 2016 draft (source: FDA) Lean Lab "Data Integrity: The extent to which all data are complete, consistent and accurate throughout the data lifecycle." SOP guidance MHRA Guidance for industry on data integrity (source: MHRA)

For more information www.mt.com/labX 5A 5B 5C 5D

Paperless Lab Academy® 2017 Workshop session 5D DAY 2. 12:30 - 13:30 Welcome Data governance: Answering the ALCOA-based data integrity and data quality topics and to the lifecycle of your data Content

Name Gunnar Danielson Company Mettler Toledo Job Title Global Software Solutions Manager Email [email protected] Program Website www.mt.com

Objectives functioning system (not theory but a solution that has been installed globally for years using common To ensure data quality: the SOP steps, calculations, and current best technology standards) that is results and records are managed automatically and designed according to the guidance of ALCOA based electronically. regulations. Presentation To ensure data integrity: complete data must be fully eeData governance: Data integrity and data quality traceable and follow the guidance of ALCOA. Start at from the data source the beginning – typically at the balance (all benchtop instruments) – with data integrity and data quality eeSOP management optimized on a bench top from the source. Self-documenting labs begin on the instrument bench. eeMeta data from the start of the lifecycle to all The industry trend has changed from efficiency and informatics systems optimizing processes towards data integrity. Now eeSimplify integrated instruments and software Workshop with instrument control software it is possible to systems achieve both simultaneously – optimize and maximize efficiency in the Lab and achieve data integrity. This Minimize the total cost of ownership of an integrated workshop will demonstrate the comparison of the lab: cost of a system that supports regulation compliance eeLower implementation costs vs. the cost of non-compliance. eeLess expensive to validate a complete system vs. each instrument Session learnings eeVendor maintained instrument integration without programming Interact with a live system where the complete raw data/all meta data, is created, maintained and eeFrom instrument level software up to LIMS and accessible on any system within the lab. A fully cloud storage Digital Convergence 2020 Roadmap for

71 Paperless Lab Academy® 2017 Presentation DAY 2. 14:30 -14:50

Practical approaches for an effective data governance programme

name Kurt In Albon

company Lonza

job title Director Global Quality Assurance

email [email protected]

website www.lonza.com

The presentation will outline the implementation of a cycle, its impact on regulatory compliance and data global Data Governance structure, aiming at aligning integrity, from inception of a record to its destruction the diverse structures of information created in a Life after retention time. Science company. It will outline the information life Digital Convergence 2020 Roadmap for

72 Paperless Lab Academy® 2017 Presentation DAY 2. 14:50 - 15:10 Welcome Version control: The software industry’s solution to data integrity problems Content name Katrin Leinweber

company Vetter Pharma-Fertigung GmbH & Co.KG

job title Process Manager Paperless Lab

email [email protected]

website www.vetter-pharma.com Program

Programmers need to be able to collaboratively write, Because Git is Free and Open Source, a whole review and repair software source code. Various ecosystem of tools and workflows has sprung up to source/change/version control systems have been provide security features, automation options, easy- adopted since the 1960s to retrace, attribute, backup to-use interfaces and more. Thus, Git is no longer only and restore changes throughout a software’s lifecycle. useful for programming, but also for validation, data

analytics, document & project management, and even Presentation Since 2005, companies research institutions and for marketing, design, etc. volunteer projects have converged on one such system: Git. This presentation will explain, why Git can This presentation will explain Git’s basic jargon, be considered to have the last word on data integrity connect some of its core functions to pharma for all kinds of digital files. Most importantly, it puts requirements and highlight potential use-cases in our the audit trail front and center, and (figuratively) industry and its regulators. expands it into 3D, so that review and continuous learning moves from possible to inevitable. Workshop Digital Convergence 2020 Roadmap for

73 Paperless Lab Academy® 2017 Barcelona, April 4th & 5th

PLA2017 Satisfaction survey

YOUR OPINION IS IMPORTANT FOR US

Share your views on the event! bit.ly/PLA20172lGvZJ6

@Paperless_Lab Paperless Lab Academy www.paperlesslabacademy.com Paperless Lab Academy® 2017 Presentation DAY 2. 15:10 - 15:30 Welcome Management of research data in academia: development of a modern research infrastructure with open source software Content

name Dr. Nicole Jung

company Karlsruhe Institute of Technology (KIT)

job title Research manager

email [email protected] Program

website www.kit.edu

Modern infrastructure for the collection, processing collection of research results in a cost-effective and and storage of research data is the prerequisite for a simple manner, and to optimally network researchers. structured documentation of research projects and While being applicable in other fields of research, the

their preparation for an efficient re-use. As many ELN allows in particular the input and organization of Presentation other institutes, the Karlsruhe Institute of Technology all research-relevant data in the field of chemistry. By (KIT) has hitherto faced a lack of freely usable, creating an interface between the two systems ELN specific software for the modern handling of research and repository, a direct combination of acquisition data in the field of chemical sciences. and documentation as well as publication and storage of data sets and information is implemented. In Recently, the department of Chemistry at the KIT contrast to the maintenance of other repositories, the initiated the development of two independent IT additional effort for the contribution to the repository systems, an ELN and a web repository, to establish with additional data is no longer required. a freely available infrastructure that introduces Workshop new ways of data collection, management and the The infrastructure will be prepared for its use in the provision of the obtained information. The Open related discipline biology, so that biological research Source project for the development of both systems, work will benefit from a modern infrastructure. is intended to make a significant contribution to Digital Convergence 2020 Roadmap for

75 Presentation 13 DAY 2. 14:30 -14:50 Paperless Lab Academy® 2017 Presentation DAY 2. 15:30 - 15:50 Welcome Internet of Lab Things – Visualizing your data and yielding important results without an army of data scientists Content

name Ross Emerton

company Astrix Technology Group

job title Vice President / Chief Architect

email [email protected] Program

website www.astrixtechgroup.com

Internet of Laboratory Things – Lessons Learned eeMajor benefits of IoT that may be applicable to the from Other Industries. The Internet of Things (IoT) laboratory is expected to become a large industry of its own, eeIoT lessons from other industries that are projected to hit the $7 trillion to $20 trillion revenue applicable to the Internet of Laboratory Things Presentation mark by 2020. However, there still is a certain amount (IoLT), including 4 highly-applicable lessons dealing of hype and it may take a few years before industries with data collection, data enrichment, visualization see IoT fully mature as an integrated technology tools, and predictive analytics and become fully mainstream. Since the term “IoT” was coined in 1999, industries have been working to eeApplicable IoT challenges faced in other industries apply the technologies to gain insight, save cost, and including cost, integration, security, and the improve revenue. The resulting explosion means application of industry-specific knowledge smart devices are now in use in homes, as wearables,

eeProven techniques for overcoming challenges: Workshop and in many industries. from strategy to implementation platforms and Ross Emerton, VP / Chief Architect from Astrix where the lessons learned can be applied. Technology Group will discuss the following four aspects. Digital Convergence 2020 Roadmap for

77 Paperless Lab Academy® 2017 Digital Convergence 2020 Roadmap for

78 ® Media Partners Paperless Lab Academy 2017 Welcome

THANKS TO OUR

MEDIA PARTNERS Content Program Presentation Workshop

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79 Paperless Lab Academy® 2017

Transform scientific 2020 information into Roadmap for actionable insight digital convergence

Barcelona, April 4th & 5th

Paperless Lab Academy® 2017

@Paperless_Lab Paperless Lab Academy www.paperlesslabacademy.com