Amsterdam 13-14 May 2014 Sponsors & Partners -1- Welcome by Chairman Discover the enormous potential of Paperless Data Management It is pure waste to perform labor-intensive hunting for information across multivendor, multi-technique databases, manual transcription checking and manually creating reports. The need to be able to cross-functionally collaborate between R & D, integrate with external partners (CMO & CRO's), support Quality assurance and manufacturing, is exponentially expanding. Continues processing, extended regulations, e-submission processes, QbD and increased externalization, requires a start-to-finish lifecycle approach to reduce process variability. Today's significant social and technological breakthroughs will require a fundamental re-think and re-design of how companies integrate new scientific methods in their research and manufacturing operations. Paperless laboratory is the result of a mindset change. The theme of the congress focusses on the relevant aspects moving from paper towards “less paper” operations. A selection of over 20 Industry presentations and 12 targetted detailed 1 hour hands-on interactive workshops, will help you, to integrate your heterogeneous laboratory landscape from begin to end. I like to welcome you at The Paperless Lab Academy to get concrete answers from domain experts, solution providers and industry peers, how to address these challenges in your organization. The congress will start on May 13 and last two full days. Convenient venue location nearby Schiphol airport. (Holiday Inn / RAI). Several optional post congress training courses will be available. Thanks to our event sponsors we are able to offer industry visitors a free entry to the congress. Peter J. Boogaard CEO Industrial Lab Automation and organizer of the Paperless Lab Academy -2- Content Welcome by Chairman ................................................................................ 2 Content ..................................................................................................... 3 Program Day 1 - Tuesday 13 May 2014 ....................................................... 6 Program Day 2 - Wednesday 14 May 2014 .................................................. 8 The journey towards a data driven R&D organization ................................. 10 Progress toward Creating an Intelligent and Automated Analytical Laboratory ............................................................................................................... 11 ACD/Labs ................................................................................................ 12 Breathing Life into Dead Data ................................................................... 13 Tracking and tracing of documents in a GMP environment .......................... 14 PerkinElmer ............................................................................................. 15 Medtronic Supplier Owned Quality Program Supplier Quality Portal, iLab Integration into SAP® ............................................................................... 16 Accelrys ................................................................................................... 17 Deployment and impact of a Reference Standard Database ........................ 18 Business improvements in DMPK using Morphing Software ......................... 19 IDBS ....................................................................................................... 20 Mobile Technology and the Changing Face of the Lab ................................ 21 SIEMENS ................................................................................................. 22 Integrated Quality from Design to Manufacturing ....................................... 23 Integrated ELN & SDMS betters your chances for becoming Paperless......... 24 Lonza ...................................................................................................... 25 Looking beyond LIMS: A results-oriented approach to QC Automation ......... 26 Workflow implementation in lab balances .................................................. 27 -3- Dotmatics ................................................................................................ 28 Paperless Collaborative Research .............................................................. 29 Requirements for a holistic Approach to Solve Long Term Archiving Issues .. 30 Workshop 1: Best practice integration of ELN & LIMS ................................. 31 Workshop 1: More Science, Less Paper – use the technology, see the benefits ............................................................................................................... 32 Workshop 1: Simple approaches to map lab processes ............................... 33 Workshop 1: Integrated Quality from Design to Manufacturing ................... 34 Publications ............................................................................................. 35 “From Paper to the Cloud – Minimising the Risk” ........................................ 36 Improving Efficiency in Laboratory Sample Management ............................ 37 Agilent ..................................................................................................... 38 Data flow and processing.......................................................................... 39 The Next Generation R&D Cloud to Integrate and Maximise the Value of Scientific Data .......................................................................................... 40 Workshop 2: 1Lab - Innovation in Lab automation ..................................... 41 Workshop 2: Impact of a LES when working in a SAP-QM environment ....... 42 Workshop 2: Reference Architecture for Lab Integration & Data Standards Requirements .......................................................................................... 43 Workshop 2: Managing and Controlling the Life Cycle of Impurities in Drug Development ........................................................................................... 44 Workshop 3: Effective Scientific Data Management and process optimisation45 Workshop 3: Making the most of your ELN data with smart searching, reporting and analysis .............................................................................. 46 Workshop 3: A novel software approach to improving sample management with laboratory efficiency .......................................................................... 47 Workshop 3: Going Mobile in the Lab – Just a Hype or Useful for the Lab? .. 48 -4- From Paper to Paperless – More than LIMS with LES .................................. 49 In the year 2525... A brief look at technology trends .................................. 50 iVention ................................................................................................... 51 The agile lab: Advantages of lab automation in the cloud ........................... 52 Five things you always missed in Excel ...................................................... 53 Delivering Scientific Data Anywhere using the AnIML Data Standard ........... 54 Self-documenting paperless processes to support ICH Q10 knowledge management ........................................................................................... 55 Industrial Lab Automation ......................................................................... 56 -5- Program Day 1 - Tuesday 13 May 2014 8:15 8:45 9:00 9:40 10:00 10:20 10:40 11:10 11:30 11:50 12:10 12:30 12:50 Registration Opening remarks and Welcome The journey towards a data driven R&D organization Progress toward Creating an Intelligent and Automated Analytical Laboratory Breathing Life into Dead Data Tracking and tracing of documents in a GMP environment Coffee break Medtronic Supplier Owned Quality Program Supplier Quality Portal, iLab Integration into SAP® Reference Std. Management Deployment and Impact of a Reference Standard Database Business improvements in DMPK using Morphing Software Mobile Technology and the Changing Face of the Lab Integrated Quality from Design to Manufacturing Networking Lunch -6- Peter Boogaard Lawrence Barratt Gerhard Noelken Industrial Lab Automation Unilever Nick Nugent Ineke Verweire Allotrope Foundation / Pfizer Inc. ACD/Labs Anabiotec NV Iraida Quinn Medtronic Gudrun Speidel Novartis AH Gayle Dagnell Evotec Dr. Paul Denny- IDBS Gouldson Jan Verelst / Siemens Patrick Bossuyt 14:20 14:40 15:00 15:20 15:40 16:40-17:40 Parallel Workshops 1 16:00 16:10 Integrated ELN & SDMS betters your chances for becoming Paperless Looking beyond LIMS: A results-oriented approach to QC Automation Workflow implementation in the laboratory Paperless Collaborative Research Requirements for a holistic Approach to Solve Long Term Archiving Issues Elevator workshop pitches Afternoon networking break Mukunth Venkatesan Agaram Technologies Sinéad Cowman LONZA Kai Gloth Sartorius Dr Mariana Vaschetto Wolfgang Colsman Dotmatics Best practice integration of ELN & LIMS More Science, Less Paper use the technology, see the benefits Simple approaches to map lab processes Integrated Quality from Design to Manufacturing Guido von Dahlen Sinéad Cowman / Rob Lutskus Claire Hill LabWare Jan Verelst / Patrick Bossuyt SIEMENS 17:40- Networking reception 19:45 -7- Osthus GmbH LONZA IDBS Program Day 2 - Wednesday 14 May 2014 8:20 8:30 9:10 9:30 9:50 11:00-12:00 Parallel Workshops 2 10:10 10:30 12:00 Recap and opening Day 2 From Paper to the Cloud – Minimising the Risk Improving Efficiency in Laboratory Sample Management Data flow and processing The Next Generation R&D Cloud to Integrate and Maximise the Value of Scientific Data Elevator workshop pitches Tea & Coffee break Vince Woodall David Stokes limsqc.com LLC Venostic Dan Chapman Waters Innovation in Lab automation Gerben de Haan / Oscar Kox Jeroen de Haas 1Lab / Asystance / iVention PerkinElmer Wolfgang Colsman Osthus / Allotrope Foundation ACD/Labs Impact of a LES when working in a SAP-QM environment Reference Architecture for Lab Integration & Data Standards Requirements Managing and Controlling the Life Cycle of Impurities in Drug Development Change workshops -8- Martin Hermsen Eurofins BV Steve Yemm Core Informatics Albert Van Wyk 12:05-13:05 Parallel Workshops 3 13:05 14:30 14:50 15:10 15:30 15:50 16:10 16:30 Effective Scientific Data Management and process optimisation Making the most of your ELN data with smart searching, reporting and analysis A novel software approach to improving sample management with laboratory efficiency Going Mobile in the Lab. Just a Hype or useful? Networking Lunch From Paper to Paperless – More than LIMS with LES In the year 2525... A brief look at technology trends The agile lab: Advantages of lab automation in the cloud Five things you always missed in Excel Delivering Scientific Data Anywhere using the AnIML Data Standard Self-documenting paperless processes to support ICH Q10 knowledge management Closing of Paperless Lab Academy 2014 -9- Freek Varossieau Agilent Alister Campbell Dotmatics Dan Chapman Waters Jack Gibson Accelrys Annemarie Braber Vince Woodall Nizo Food Research limsqc.com LLC Peter Balk Peter Vijn NSure Burkhard Schaefer Peter Boogaard The Edge Consulting BSSN Software Industrial Lab Automation The journey towards a data driven R&D organization Name Company Job Title Email Lawrence Barratt Unilever Discover Program Director: Digital R&D [email protected] Abstract: Double the size of our business, whilst reducing our environmental footprint and increasing our positive social impact: A number of corporate initiatives are in place to achieve this goal. The ‘Digitally enabled R&D’ thrust is one of the responses in R&D to the challenges of the Compass. Major global change programmes in Product Lifecycle Management, Knowledge Management and e-Science have been established. Among our e-Science challenges are: - How to embrace the acceleration in the advances of Big Data and IT which are changing the face of exploratory Science? - How to continue to build and exploit on our Islands of excellence while creating a core infrastructure and toolset which will reach everyone in our Research organisation, driving change in the way we value and use data? The flagship project for the programme is the global launch of an Electronic Laboratory Notebook. This presentation will outline the progress and challenges overcome on our e-Science journey so far. - 10 - Progress toward Creating an Intelligent and Automated Analytical Laboratory Name Company Job Title Email Gerhard Noelken Pfizer Inc. Business IT Lead Science & Technology - Allotrope Foundation [email protected] Abstract: Can you find the data you need in seconds, regardless of who, what, when, where, why, or how it was generated? Can you click-and-create complex technical reports or large sections of regulatory submissions in seconds? Can you click-and-share data with colleagues in your organization? Or click-andcompare your data with data obtained from your partner organization? Are your laboratory systems smart enough to prevent errors before they occur? Being able to answer "Yes" to these questions is our motivation for building an open framework for laboratory data using common information standards. This presentation describes our development of a commercial-quality framework in partnership with a professional software company, with funding and support from the pharmaceutical industry. The framework is supplemented with limited feature, proof-of-concept software to demonstrate how future commercial software solutions could use the framework to acquire, record, search for, and automatically archive HPLC-UV data. The framework contains three key components: 1) a common, non-proprietary file format that stores laboratory data in a human-readable format (e.g., AnIML-XML); 2) a metadata repository that ensures accurate, complete, and consistent experimental context is stored with raw data, creating an archive-ready file format; and 3) freely distributable class libraries (software tools) that instrument and software providers can use to create novel, innovative solutions using common information standards. We will also discuss how we are evolving iterative solutions using agile development to achieve this vision and to help create an open "ecosystem" for new, innovative software for laboratory informatics. - 11 - Breathing Life into Dead Data Name Company Job Title Email Nick Nugent ACD/Labs International Manager [email protected] Abstract: Recent surveys from the International Data Corporation (IDC) suggest that knowledge workers spend 15-35% of their time searching for information. A previous study by the same firm estimated that an enterprise with 1,000 knowledge workers loses a minimum of $6 million a year in the time workers spend searching for-and not finding-needed information. These types of issues are very relevant in the pharmaceutical and chemical industries. As a result, many laboratory experiments represent expensive, time-consuming repeats of previous experiments, simply because the data cannot be found or, if found, cannot be re-used. 'Dead' data is prevalent throughout the industry as the direct result of the traditional one-and-done life cycle whereby one experiment produces information that is analyzed and interpreted once; thus the resulting knowledge is stored in a static format. Once the knowledge is extracted from the data by the scientist, the initial lab information effectively becomes 'dead' data and is no longer useful beyond the specific initial purpose. As a result massive opportunities for transforming this information and knowledge to corporate intelligence are squandered. New technology strategies need to be applied to help solve the challenges related to data management and knowledge sharing. Unified Laboratory Intelligence is a technology framework that can address these challenges headon and requires contributions from a broad range of technology vendors. With this framework in place, organizations can create a chemical intelligence-frominformation ‘live’ cycle that enables research scientists across an R&D organization to easily search, quickly retrieve, and efficiently gain insight and reapply it to improve decision-making, accelerate development, and decrease cost. - 13 - Tracking and tracing of documents in a GMP environment Name Company Job Title Email Ineke Verweire ANABIOTEC NV COO [email protected] Abstract: Thinking about the function of LIMS systems, you immediately associate the saving, processing and tracing of samples and raw data. But what with the related documents? The SOP’s, the protocols, methods, reports? All documents for which in a GMP environment, you have to demonstrate version management, approvals and history track? Anabiotec has found a solution using the document manager module of the Labware LIMS system. The big advantage is the integration of the documents is the linking between data and documents. This makes the daily use of the lab technician a lot more comfortable. - 14 - Medtronic Supplier Owned Quality Program Supplier Quality Portal, iLab Integration into SAP® Name Company Job Title Email Iraida Quinn Medtronic Galway Ireland Program Manager, Supplier QA Engineering [email protected] Abstract: QA/QC laboratories in organizations that use SAP® are facing the need to implement tighter integration between the data that they are producing and the enterprise system. In some cases organizations are looking to further leverage their investment in SAP by consolidating technologies across the organization in order to reduce IT costs and to ensure timely, accurate delivery of data into SAP in order to support decision making in the manufacturing process. This presentation will discuss the Supplier Owned Quality Program (SOQ) at Medtronic which is a new process of executing quality control analysis at the suppliers premises via web portal access using the PerkinElmer iLab and SAP QM connector to SAP®. The SOQ Program allow Medtronic to be more efficient in accepting products at their manufacturing sites without duplicating tests at product arrival. When an order is entered in SAP® the system will request samples to be tested by the Suppliers per the Medtronic specifications; the supplier is requested to enter their test results through the PerkinElmer’s iLab web portal which is connected to the Medtronic SAP® system; if test results met the quality specifications, the system will generate a SOA which authorizes the supplier to ship their product to Medtronic. The implementation of uploading quality control data directly into SAP® will benefit product quality, cost savings, increase the efficiency and will have a positive impact on operational excellence at Medtronic and its key Suppliers. - 16 - Reference Standard Management - Deployment and Impact of a Reference Standard Database Name Company Job Title Gudrun Speidel Novartis Animal Health Global QC Project Support Abstract: The purpose of a Reference Standard database is to verify analysis and shipment of reference standards in due time, to reduce administrative work, and to improve the collaboration between customer, supplier and recipient by providing a worldwide access to one database a clear overview of disposability from quantity and shelf life online availability of all relevant data and documents (e.g. Certificates of Analysis) in one system completion of order form directly in the database - 18 - Business improvements in DMPK using Morphing Software Name Company Job Title Email Gayle Dagnell Evotec (UK) Ltd Senior Research Scientist 1 [email protected] Abstract: Evotec, a drug discovery organization, utilises BioRails to manage Drug Metabolism and Pharmacokinetics (DMPK) and biological experimentation. BioRails software is a unique solution, flexible enough to address the full range of activities from routine in vitro screening to in vivo studies. BioRails combines traditional data management with an electronic laboratory notebook. It has been designed to be flexible enough to cover everything from HTS to in-vivo studies and simple enough so that scientists can be largely self-sufficient, defining their own data capture templates, searching, analysing and reporting on research studies. Evotec medicinal chemistry teams use BioRails Project Tracking and Optimisation (PTO) to make requests for assays and after submission the requester can track the status of the request and when complete, retrieve the results. Evotec DMPK teams use BioRails Data Management (DM) to design flexible processes and workflows for capturing experimental data, allowing scientists to use the system across the full range of scientific investigations. Evotec understands that each customer has different needs, internal capabilities and capacities. BioRails allows Evotec scientists the freedom to choose the best approach for their needs. Leveraging the benefits of its large, flexible, highquality organisation allows Evotec to offer cost-effective one-stop solutions. By working with Evotec and leveraging its integrated platform, customers are able to drive down cycle times to allow for the advancement of drug discovery programmes at a faster pace. The unique flexibility of the BioRails software allows Evotec to provide innovative and efficient solutions that are always focused on the needs of its customers. - 19 - Mobile Technology and the Changing Face of the Lab Name Company Job Title Email Dr. Paul Denny-Gouldson IDBS VP Translational Medicine [email protected] Abstract: The nature of science shares striking similarities across many industry verticals. Whether it’s biologics, chemicals or new product formulations, they are all performed with a high degree of similarity from company to company. This is exemplified by the fact that R&D informatics platforms such as LIMS, ELNs and SDMS are used, and provide real benefits in all science-related sectors. Although this seems fairly straightforward, things are changing. Organizations are under increasing business pressure to innovate faster and improve efficiency and throughput, all while boosting profitability. With all of these challenges ahead, they’re changing the way they work and the informatics they use. One way of innovating is by becoming mobile. - 21 - Integrated Quality from Design to Manufacturing Name Company Job Title Email Jan Verelst / Patrick Bossuyt Siemens Business Development Manager SIPAT & Life Sciences [email protected] / [email protected] Abstract: • Applying Collaborative manufacturing • Shifting from Quality by Inspection to Quality by Design • Tearing down the wall between R&D and manufacturing - 23 - Integrated ELN & SDMS betters your chances for becoming Paperless Name Company Job Title Email Mukunth Venkatesan Agaram Technologies CEO & Director [email protected] Abstract: A new approach to become a paperless lab by deploying an electronic lab notebook (ELN) that is fully integrated with a Scientific Data Management System (SDMS). Agaram will discuss about a real project experience in deploying such a solution, its benefits, achievements and down-side etc in this presentation. - 24 - Looking beyond LIMS: A results-oriented approach to QC Automation Name Company Job Title Email Sinéad Cowman Lonza Bioscience EU Business Development Manager [email protected] Abstract: New demands are coming from QC to further automate processes in the production area and the lab as well as deliver better analytics demonstrating control of critical production areas, such as clean room suites and water systems. IT and QC personnel must adjust accordingly, looking beyond traditional LIMS and ELN features that deliver a paperless and more compliant process well beyond the lab. This talk will discuss the following: • Current IT Challenges and Quality Systems • LIMS as the Center of Quality Systems • Customer Requirements for automated solution • TCO Considerations and Business Benefits - 26 - Workflow implementation in lab balances Name Company Job Title Email Kai Gloth Sartorius Lab Products and Services Software Engineer Embedded Computing [email protected] Abstract: With the new Q-Apps individual workflows (SOP´s) can be implemented directly in Cubis laboratory balances. By this it can be ensured that the SOP is fulfilled always 100 %. With the additional web based communication interface connectivity to LIMS or middleware is easily possible. - 27 - Paperless Collaborative Research Name Company Job Title Email Dr Mariana Vaschetto Dotmatics Limited VP Marketing [email protected] Abstract: Today’s research involves combined efforts from multiple laboratories. The concept of collaborative research goes beyond the ability of seamlessly exchanging data between groups, labs or institutions. It involves the creation of knowledge from real-time discussions between scientists who not only generate data, but contribute to a project with data analysis and conclusions. Informatics is at the centre of this process, facilitating the exchange of ideas relating to a project in a paperless manner. In this presentation we will introduce examples of how different research teams utilise the web-based Dotmatics Platform to enable scientists to: • • • • • • request work or tests to be performed program, capture and store experiments exchange results and information execute extensive queries perform analysis and reports, and… engage in real-time discussions to generate true novel knowledge The ability to perform all of these tasks via mobile devices, computers or laptops in a secure and compliant way allows users to substitute pen and paper with efficient electronic devices. - 29 - Requirements for a holistic Approach to Solve Long Term Archiving Issues Name Company Job Title Email Wolfgang Colsman Osthus GmbH CTO [email protected] Abstract This session will present requirements for long term archiving solutions. We will share some results from the Allotrope foundation work on archiving. - 30 - Workshop 1: Best practice integration of ELN & LIMS Host E-mail Date/Time Guido von Dahlen [email protected] Tuesday 13 May 2014 / 16:40-17:40 Opportunity / Problem statement Organizations that are considering purchasing an ELN and integrating it with an existing LIMS have to make important decisions about how to make best use of the functionality each type of application provides. This workshop will provide an overview of the core capabilities of LIMS and ELN, and provide “best practice”, practical advice on how to integrate the two applications to maximize their potential and minimize functional overlap. At the conclusion of this education session, participants will be able to • • • • Understand the core capabilities of LIMS and ELN Understand how best to use ELN, in the context of using it with an existing LIMS Avoid the potential pitfalls of LIMS+ELN interfacing, and functional overlap Use a best practice approach to reconfiguring methods to work efficiently in a LIMS+ELN environment. - 31 - Workshop 1: More Science, Less Paper – use the technology, see the benefits Host E-mail Date/Time Sinead Cowman and Rob Lutskus [email protected] / [email protected] Tuesday 13 May 2014 / 16:40-17:40 Opportunity / Problem statement New demands are coming from QC to further automate processes in the production area and the lab as well as deliver better analytics demonstrating control of critical production areas, such as clean room suites and water systems. This workshop will take participants through an analysis of a typical sample lifecycle for QC environmental and utility monitoring: • • • Identifying the areas where paper still is required, even with traditional lab systems in place Highlighting steps that add no value to the sample lifecycle, and even introduce opportunities for compliance errors. Illustrating the unique data analysis and trending needs to demonstrate control of production areas and systems, and the inadequacy of current methods to deliver critical information. The workshop then will allow participants to experience hands-on usage of technology to solve these problems, such as: • Paperless sampling with cleanroom-ready tablet PCs. • Accurate bulk lab sample processing with barcode technology. Ad hoc analyses with visualization and trending analytical tools. At the conclusion of this education session, participants will be able to • • • • Analyze the steps in their own Quality Control sample lifecycle that introduce waste or compliance errors. Identify technology solutions to eliminate these non-value added steps and improve process compliance. Specify analytical tool requirements for excursion investigations, CAPA and routine reporting. Quantify the net benefits of a paperless sample lifecycle in terms of increased and improved quality control. - 32 - Workshop 1: Simple approaches to map lab processes Host E-mail Date/Time Claire Hill [email protected] Tuesday 13 May 2014 / 16:40-17:40 Opportunity / Problem statement The increasingly sophisticated instrumentation and software environments that support today’s labs make process understanding more important than ever. Process mapping can be a powerful tool to help you understand how functions and activities interact, reduce workflow complexity, manage change, and prepare for the future. In this workshop we will: • • Introduce some tips and techniques to make process mapping both simple and effective Review case studies where these techniques have been successfully applied. At the conclusion of this education session, participants will be able to • • • Understand and communicate some of the benefits of process mapping Understand and apply some techniques for gathering and presenting process information to a cross-functional audience Understand and apply some techniques for identifying process improvements - 33 - Workshop 1: Integrated Quality from Design to Manufacturing Host E-mail Date/Time Jan Verelst / Patrick Bossuyt [email protected] / [email protected] Tuesday 13 May 2014 / 16:40-17:40 Opportunity / Problem statement Speed up time–to–market and ensure sustainable quality by At the conclusion of this education session, participants will be able to • Applying Collaborative manufacturing • Shifting from Quality by Inspection to Quality by Design • Tearing down the wall between R&D and manufacturing - 34 - Publications – www.industriallabautomation.com/Publications.php It is pure waste to perform labour-intensive hunting for information across multi-vendor, multi-technique databases, manual transcription checking and to manually create reports. What are these challenges to create value for the consumers of the laboratory data? When considering data integration, we must first stop thinking ‘technology’. Integration is not just about instruments or other software platforms. Instead, it is about integrating processes, accelerating ideas and facilitating mandatory compliance requirements more economically. The power of a Paperless Laboratory is the ability to enable organizations to implement self-documenting processes that produces GxP-compliant documentation which eliminates unnecessary tasks from the workflow, to result in a significant cost of non-compliance to support corporate Cost of Goods Sold (COGS) optimization. Headaches about upgrading your software? Considerations for software expansions and upgrades. Before you decide to rock the boat, several key decision-making steps can help to ensure a smooth and successful upgrade. The last thing to do is to start is a project to change a working enterprise application environment.... It is time to put more emphasis on the preventing facet and reorder the sequence of the CAPA abbreviation into PACA. It is proven that his theory to adopt continuous improvement strategies to decrease variability resulted in significantly better products and financial performance. For years, other industries, including the automobile, aviation and food & beverage industries, have adopted, very successfully, the Six Sigma QbD philosophy. An introduction how informatics will drive Pharma development towards Quality by Design. Food companies are becoming pharma companies. Developing pro-active approach adapting QbD as a standard model and implementing new tools such as PAT, KQI and CQA will leverage learning’s from both industries. Agile processes integrating “intelligent Equipment” will result in a new systemlandscape allowing a seamless dataflow from start-to-end. Headaches about upgrading your software? Considerations for software expansions and upgrades. Before you decide to rock the boat, several key decision-making steps can help to ensure a smooth and successful upgrade. The last thing to do is to start is a project to change a working enterprise application environment.... - 35 - “From Paper to the Cloud – Minimising the Risk” Name Company Job Title Email David Stokes Venostic Global Lead, Life Sciences [email protected] Abstract: Use of ‘The Cloud’ for computing purposes makes the use of paper documents and traditional record keeping virtually redundant – or does it? In this 40 minute session, well-known ‘regulated Cloud pundit’ David Stokes will provide an update to his ISPE Pharmaceutical Engineering article “Compliant Cloud Computing - Managing the Risks”. Bringing the 2013 article up-todate, the session will show how a significant number of regulated companies are moving their GxP data and applications into the Cloud – and how specialist Cloud Service Providers are meeting the needs of the industry by developing compliant Infrastructure as a Service and Software as a Service applications. In keeping with the theme of the conference, the session will also look at how regulated organisations can do away with paper as they move into the Cloud, at how paper based processes need to be adapted to become compliant Cloud based applications, and where paper just might need to be retained in order to assure regulatory compliance. - 36 - Improving Efficiency in Laboratory Sample Management Name Company Job Title Email Dan Chapman Waters Informatics Solutions Consultant, Europe [email protected] Abstract: The management of samples and results is an ongoing challenge for laboratories faced with continuously increasing analysis requests, a need for more rapid turnaround times, and legacy paper based processes. This session will highlight recent innovations in the Waters Informatics portfolio that aid sample management, data retrieval and lab efficiency to make the connected paperless lab a closer prospect. - 37 - Data flow and processing Name Company Job Title Email Martin Hermsen Eurofins BV in Barneveld R&D Laboratory Technician [email protected] Abstract: At Eurofins Analytico we have changed our traditional paper based registration process to an electronic alternative. This presentation will include our experiences by moving these registration, storage, achieving processes to such an electronic data handling system. I’m working for about 30 years at Eurofins Analytico. I started as organic analyst on the section PAH with LC. Later on I also work with GC and GCMS for analysis pesticides and volatiles. For 6 years I was team leader of the department Special components and assistant department manager organics. The last 8 years I’m R&D analyst and my duties are automation of data handling (Review Browser and Run Master) and implantation of new technics and applications (LTM and LCMS) and improvement of applications - 39 - The Next Generation R&D Cloud to Integrate and Maximise the Value of Scientific Data Name Company Job Title Email Steve Yemm Core Informatics UK Sales Director [email protected] Abstract: Modern R&D organizations are rapidly adopting cloud-based IT infrastructures as they externalize a growing segment of operations spanning product research, discovery, and development. This is particularly evident in the life sciences industries where companies are moving from centralised, corporate-based facilities to a virtual network of contract research, development, and manufacturing organizations (CRDMOs), and academic institutions and corporate partners to enable product discovery and development. Software providers possessing commercial cloud-based infrastructures and services are poised to meet the needs of the life science industry as this externalized, collaborative IT paradigm shift matures. What is presented is a platform technology with the capability to integrate disparate data (LIMS, federated systems, data warehouses, ERPs, ELNs) while providing security measures that enable remote access across a range of devices for employees, and restricted access for CRDMOs. - 40 - Workshop 2: 1Lab - Innovation in Lab automation Host E-mail Date/Time 1Lab / Oscar Kox / Gerben de Haan [email protected] / [email protected] Wednesday 14 May 2014 / 11:0012:00 Opportunity / Problem statement The laboratory environment is in motion. Demands from the market, authorities and internal customers increase. Customization in services whilst improving the quality level is required to stay competitive. At the same time budgets are under pressure. At the conclusion of this education session, participants will be able to At the end of this session participants will have an insight in the way new technology and license models will change the lab automation market. Cloud based lab automation tools will improve the agility/flexibility of the lab, reduce costs, improve knowledge and scientific awareness throughout the organisation. Smart deployment principles significantly reduce the timespan and costs of implementation projects. - 41 - Workshop 2: Impact of a LES when working in a SAP-QM environment Host E-mail Date/Time Scott Chiu, Global IT Manager Medtronic SAP Quality Processes & Jeroen de Haas, Product Manager QA/QC PerkinElmer [email protected] Wednesday 14 May 2014 / 11:0012:00 Opportunity / Problem statement The experiences of implementing SAP QM for quality control at various Medtronic laboratories. The project of interfacing instruments and Waters Empower to SAP QM with the PerkinElmer SAP connector. The Impact of a Laboratory Execution System when working in a SAP-QM environment when you want to provide access to your suppliers for executing quality tests for incoming goods analysis. At the conclusion of this education session, participants will be able to • • • How to address laboratory specific requirements outside of SAP to reduce costs and provide flexibility for the lab. How to enhance lab efficiency and productivity by Including an integrated platform in the lab as part of SAP How to go paperless in the lab to ensure real operational excellence - 42 - Workshop 2: Reference Architecture for Lab Integration & Data Standards Requirements Host E-mail Date/Time Wolfgang Colsman [email protected] Wednesday 14 May 2014 / 11:0012:00 Opportunity / Problem statement Analytical laboratory processes have to deal with different instruments from different vendors, different ELN/LIMS or LES systems, different sites and collaboration with external partners like CROs and CMOs. This situation leads to inefficient processes and high costs due to insufficient data integration and accessibility. Data mining, data analytics and predictive modelling capabilities are limited by incomplete or inconsistent metadata and proprietary data formats. The workshop will provide the audience with a concept of a reference architecture for lab integration and a laboratory data framework which is based on open standards. At the conclusion of this education session, participants will be able to The participants will learn how the use of a data standards framework can leverage the integration across applications, laboratories and contractors. The high level requirements from different industries will be discussed in the workshop. The results will be summarized by Osthus and shared with the participants. - 43 - Workshop 2: Managing and Controlling the Life Cycle of Impurities in Drug Development Host E-mail Date/Time Albert van Wyk, Application Scientist, ACD/Labs [email protected] Wednesday 14 May 2014 / 11:0012:00 Opportunity / Problem statement The presentation highlights how a relatively new approach, Impurities Resolution Management (IRM), can be applied to help organization manage their impurity knowledge in a process environment. The most successful strategies are those that address needs in the context of sub-disciplines. This presentation illustrates how various groups within drug development have applied technology advances and good data management strategies to reduce cycle times in drug development. At the conclusion of this education session, participants will be able to Participants will learn more about some best practices and lessons learned that some organizations have used to be successful in a vastly evolving drug development and scientific technology environment - 44 - Workshop 3: Effective Scientific Data Management and process optimisation Host E-mail Date/Time Freek Varossieau [email protected] Wednesday 14 May 2014 / 12:0513:05 Opportunity / Problem statement Nowadays organizations are confronted with an increase in the amount of files created and the management of these files in time. And this is not limited to pharma industry, but also the ISO 17025 forces non-pharma organisations to think about how they organize their data management. However, organisations only benefit when the retrofit their workflows to match the new technologies offered in the market. At the end it is all about the ROI you achieve by improving your quality systems. Learn in more detail how you can streamline your dat flow by integration large data producers (QQQ, TOF) and on-line data management At the conclusion of this education session, participants will be able to • • • Identify the bottlenecks in their organisation Where to go paperless Streamline their processes using new technologies at hand - 45 - Workshop 3: Making the most of your ELN data with smart searching, reporting and analysis Host E-mail Date/Time Alister Campbell [email protected] Wednesday 14 May 2014 / 12:0513:05 Opportunity / Problem statement The shift from paper to paperless labbooks heralded a boom in laboratory data storage and should have led to increased efficiency, transparency and accessibility of the generated data. The reality is that with many commercial paperless systems this hasn’t been the case. Dotmatics’ laboratory informatics bucks this trend with the use of Browser and Studies Notebook applications. At the conclusion of this education session, participants will be able to See how data uploaded into or generated within the Studies Notebook can seamlessly be queried and shared, leading to increased efficiency by reducing repetition. Furthermore the workshop will explore the use of Studies Notebook to collaborate with third party organizations and highlight how the now transparent data can be utilized to drive scientific discussion and postulation. - 46 - Workshop 3: A novel software approach to improving sample management with laboratory efficiency Host E-mail Date/Time Dan Chapman [email protected] Wednesday 14 May 2014 / 12:0513:05 Opportunity / Problem statement The Management of samples and results is an ongoing challenge for laboratories faced with continuously increasing analysis requests, a need for more rapid turnaround times and legacy paper based processes. This workshop will explore a unique approach to sample management that combines SDMS, ELN, Stability testing and sample submission using mobile technologies to improve laboratory efficiency and accelerate decision making. At the conclusion of this education session, participants will be able to • • • Identify the weak points in lab workflows Understand the benefits of combining systems such as SDMS, ELN and stability management platforms See examples of how sample submission and mobile technology can enhance a laboratories efficiency - 47 - Workshop 3: Going Mobile in the Lab – Just a Hype or Useful for the Lab? Host E-mail Date/Time Jack Gibson [email protected] Wednesday 14 May 2014 / 12:0513:05 Opportunity / Problem statement In the laboratory the entry of data created is one of the bottlenecks in the process. Even for organizations that have moved from paper to electronic systems efficiency gains are limited. Users need to walk out of the lab and still make notes on paper or queue at central lab PC’s that are used by different users and for different applications. Hard copies of SOPs and procedures are used for lookup and carrying around laptops is also not considered as an option. In this workshop attendees can try out the applicability of a dedicated mobile application on small mobile devices for the entry of diversity of laboratory data. At the conclusion of this education session, participants will be able to • • • • Try out dedicated mobile applications on small devices for entering lab data and looking up procedures verify the usability of dedicated mobile applications vs. more complex web browsers find out if the usage of mobile devices will be able to satisfy their ergonomic needs assess a possible increase in data quality through mobile data capture - 48 - From Paper to Paperless – More than LIMS with LES Name Company Job Title Email Annemarie Braber Nizo Food Research BV QA manager/Projectmanager Processing Centre [email protected] Abstract: How a Lab Execution System supports a Processing Centre to replace paper and maintain a full tracking and tracing environment. By using the ProcessStations, all end users can be guided in their Project Workplan (SOPs) and on how to execute on their work. All in a paperless environment. - 49 - In the year 2525... A brief look at technology trends Name Company Job Title Email Vince Woodall limsqc.com, LLC President [email protected] Abstract: How technology may shape the way your lab keeps pace with integration, security, efficiency and perhaps employee satisfaction. Expect a framework presentation with a chance to participate with your questions and ideas! Trends and themes I see as important, emerging or available and not leveraged: • Security around the portability of information tablets, phones, pc’s, google glasses, USB, Bluetooth, cloud • Efficiency, ‘green’ movements, doing more, faster, with less and with a skilled labor force that is more technology savvy than ever and impatient with a boring job, good pay or not! • PAT, Process Analytical Technology, ICH 8,9,10,11 the vision of a decade is evolving into action, what is on the horizon? Will it move the job of the lab into the production line and see the analytical lab collecting cob webs? • Paperless technology, evolved but still useful, in the airport we still hang onto our printed boarding passes even with barcode read from our iPhone or galaxy phone. • Big Data – remember that old movie with Tom Cruise, ‘Minority Report’? Where just waving your hands over transparent wall sized display screens allowed you to zoom in on a crime of the future BEFORE it happened. Impact of new scientific statistical vitalization processes. - 50 - The agile lab: Advantages of lab automation in the cloud Name Company Job Title Email Peter Balk NSure CTO [email protected] Abstract: The laboratory environment is in motion. Demands from the market, authorities and internal customers increase. Customization in services whilst improving the quality level is required to stay competitive. At the same time budgets are under pressure. NSure is a certified high-tech laboratory for the agro-food industry based in Wageningen, The Netherlands. The company sells and develops tests for a wide range of quality aspects in fruit, vegetables, forest trees and ornamentals. NSure uses Alis as Lab automation solution to eliminate paper. The cloud technology that Alis runs on enables NSure to easily integrate the processes of their locations and partners around the world. - 52 - Five things you always missed in Excel Name Company Job Title Email Peter Vijn The Edge Senior Scientific Consultant [email protected] Abstract: "A new type of spreadsheet technology is presented that allows you to upgrade from data-handling to data-modelling. Major benefits of this approach are: • Improved comprehension and readability • Increased re-use • Reduced errors • Shaping automatically to any dimensionality of the data The robustness and inherent flexibility of spreadsheets written in this technology has been recognized within the pharmaceutical industry, massively reducing the effort required to accommodate the high degree of variability within biological systems. Five novel and key characteristics will be explained and demonstrated with simple practical cases, which will leave you wondering how you managed to use a spreadsheet without them." - 53 - Delivering Scientific Data Anywhere using the AnIML Data Standard Name Company Job Title Email Burkhard A. Schaefer BSSN Software GmbH President [email protected] Abstract: Making scientific data accessible to stakeholders in an integrated and unified fashion is a problem many organizations are struggling with. Traditionally, we see two types of data consumers: human beings and software tools. This talk describes a platform which allows delivering scientific data to both. The platform collects data from a number of different instruments in proprietary data formats. A conversion pipeline translates the data into the AnIML XML format, normalizing the data into a single structure. This data can then be shared and presented on a number of different platforms. Desktop applications on Windows and MacOS enable rich interaction and data analysis. A web application allows accessing the data from a web browser. Mobile apps support data access from locations where no computer is nearby. All delivery platforms handle not only result data, but also raw data from many analytical techniques. To complement the end user applications, a powerful data mapping middleware is available. It allows propagating experiment data to third party tools such as LIMS, ELN, databases, visualization, statistics and ERP systems. This approach reduces the number of interfaces required to connect the different components in a paperless laboratory and facilitates interoperability. - 54 - Self-documenting paperless processes to support ICH Q10 knowledge management Name Company Job Title Email Peter Boogaard Industrial Lab Automation Director Peter.Boogaard@ industriallabautomation.com Abstract: This presentation will highlight how QbD and Paperless Lab processes enables organizations to create start-to-finish knowledge management repository to adopt cross functional collaboration between management, scientists and engineers responsible for products in development and manufacturing, processes, equipment and facilities. The power of a paperless process is the ability to reduce variability significantly and enable organizations to implement self-documenting processes that produces both non and GxP-compliant documentation - 55 - 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 rethink 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]
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