Quality by Design (QbD) & Paperless Lab Consultancy
Making Informatics Work Across Your Teams
Academy 2014
  • DISCOVER THE ENORMOUS POTENTIAL OF PAPERLESS DATA MANAGEMENT

    Over 120 delegates were able to find the Paperless Lab Academy, which at the same time is also the first in Amsterdam. The Paperless Lab Academy is the ideal learning platform, for those considering the latest Paperless Lab initiatives or enhancing their present processes. The network reception was an ideal opportunity to network across the delegates, solution providers and experts from the market.
     
    Over 20 presentations and 12 workshop sessions with live demonstrations showed the power of a paperless laboratory to enable organizations to implement self-documenting processes, to create a start-to-finish knowledge management repository. 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.


    "One of the best attended congresses for Lab Automation" - Vincent Hentzepeter - Chief Editor LabMagazine (Read full report)

    Peter J. Boogaard    CEO Industrial Lab Automation and organizer of the Paperless Lab Academy
     

    Tom Wilkie debriefs

    2014 Program booklet 
    2014 SPONSORS  - 2014 WORKSHOPS  2014 ABSTRACTS
 

 


Recent Publications Peter Boogaard
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 economical
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 re-order 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 system-landscape allowing a seamless dataflow from start-to-end

Related Publications
Developing a strategy for a regulated electronic bioanalytical laboratory
R D McDowall

This perspective paper considers the strategy, design and implementation of an electronic bioanalytical laboratory working to GLP and/or GCP regulations. There are a range of available automated systems and laboratory informatics that could be implemented and integrated to make an electronic laboratory.
Compliant Cloud Computing – Managing the Risks
David Stokes
This article presents pharmaceutical business process owners with an explanation of what cloud computing is, how it differs from traditional Information Technology (IT) outsourcing, and how the specific risks associated with cloud computing’s essential characteristics can be understood, assessed, and mitigated.
Introducing Paperless Lab
Andreas Schild & ulf Fuchslueger
How optimization and simultaneous electronic support of actual laboratory processes can boost efficiency.
Electronic Signatures in a Regulated GMP environment
R D McDowall
Are Part 11 and Annex 11 requirements the same? In this article, Bob McDowall will be taking a tightly focused view of Annex 11,3 specifi cally the interpretation of clause 14 for electronic signatures.
A Fresh Look at the AnIML Data Standard
Burkhard Schaefer
Data standards promise easier collaboration, data exchange and interoperability in the informatics world. This article takes a deeper look at the Analytical Information Markup Language (AnIML), an emerging open format for scientifi c data, which is gaining momentum in the community as the standard is nearing completion.

 2014 presentations Presenter / abstract Outline
Peter Boogaard - Industrial Lab Automation Opening remarks and Welcome

KEYNOTE
Lawrence Barratt - Unilever The journey towards a data driven R&D organization
Gerhard Noelken - Allotrope Foundation / Pfizer Inc. Progress toward Creating an Intelligent and Automated Analytical Laboratory
Nick Nugent - ACD/LAB
Email for more information
Breathing Life into Dead Data
whitepaper
  Ineke Verweire - Anabiotec BV Tracking and tracing of documents in a GMP environment
  Iraida Quinn -Medtronic Galway Ireland Medtronic Supplier Owned Quality Program Supplier Quality Portal, iLab Integration into SAP®
Gudrun Speidel - Novartis Animal Health Reference Standard Management - Deployment and Impact of a Reference Standard Database
Gayle Dagnell - Evotec Business improvements in DMPK using Morphing Software
  Dr. Paul Denny-Gouldson - IDBS Mobile Technology and the Changing Face of the Lab
  Jan Verelst & Patrick Bossuyt - Siemens Integrated Quality from Design to Manufacturing

Mukunth Venkatesan - Agaram Technologies
Integrated ELN & SDMS betters your chances for becoming Paperless
 

Sinead Cowman - LONZA

Looking beyond LIMS: A results-oriented approach to QC Automation
  Kai Gloth - Sartorius Workflow implementation in the laboratory
  Dr Chris Collins - Dotmatics Paperless Collaborative Research
 
WORKSHOP
Wolfgang Colsman - CTO - Osthus GmbH
Email for more Workshop information
Requirements for a holistic Approach to Solve Long Term Archiving Issues 
Wolfgang Colsman - CTO - Osthus GmbH Requirements for a holistic Approach to Solve Long Term Archiving Issues
 
KEYNOTE
David Stokes - Venostic
White paper Compliant cloud computing
From Paper to the Cloud – Minimising the Risk
  Dan Chapman - Waters Improving Efficiency in Laboratory Sample Management
 

Martin Hermsen - Eurofins BV

Data flow and processing
  Steve Yemm - Core Informatics The Next Generation R&D Cloud to Integrate and Maximise the Value of Scientific Data
  Annemarie Braber - Nizo Food Research From Paper to Paperless – More than LIMS with LES
 

Vince Woodall - limsqc.com LLC

In the year 2525... A brief look at technology trends
  Peter Balk - NSure The agile lab: Advantages of lab automation in the cloud
  Peter Vijn - The Edge Five things you always missed in Excel
  Burkhard Schaefer - BSSN Software Delivering Scientific Data Anywhere using the AnIML Data Standard
  Peter Boogaard - Industrial Lab Automation Self-documenting paperless processes to support knowledge management
 




Paperless Lab Academy - Presentation abstracts
Presenter Abstract
Lawrence Barratt
Unilever
The journey towards a data driven R&D organization: Challenges and progress so far to double the size of our business
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.

Gerhard Noelken
Pfizer
Progress toward Creating an Intelligent and Automated Analytical Laboratory

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-and-compare 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. 

Nick Nugent
ACD/LABS
Breathing Life into Dead Data
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 head-on and requires contributions from a broad range of technology vendors. With this framework in place, organizations can create a chemical intelligence-from-information ‘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.

Ineke Verweire
Anabiotec BV
Tracking and tracing of documents in a GMP environment
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.
Iraida Quinn
Medtronic Galway Ireland
Medtronic Supplier Owned Quality Program Supplier Quality Portal, iLab Integration into SAP®
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 Medtroinic.

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 opertional excellence at Medtronic and its key Suppliers.
Gudrun Speidel
Novartis Animal Health
Reference Standard Management - Deployment and Impact of a Reference Standard Database
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
Gayle Dagnell
Evotec
Business improvements in DMPK using Morphing Software
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, high-quality 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.
Dr. Paul Denny-Gouldson
IDBS
Mobile Technology and the Changing Face of the Lab
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.
Martin Hermsen
Eurofins BV
Data flow and processing
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.
Mukunth Venkatesan
Agaram Technologies
Integrated ELN & SDMS betters your chances for becoming Paperless
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.
Sinead Cowman
LONZA

Looking beyond LIMS: A results-oriented approach to QC Automation
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
  • Case Study QC Micro case presented by customer (TBC)
  • Considerations and Business Benefits
Kai Gloth
Sartorius

Workflow implementation in the laboratory
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.

Dr Chris Collins
Dotmatics
Paperless Collaborative Research
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 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.
Wolfgang Colsman
Osthus GmbH
Requirements for a holistic Approach to Solve Long Term Archiving Issues
This session will  present requirements for long term archiving solutions. We will share some results from the Allotrope foundation work on archiving.

Reference Architecture for Lab Integration & Data Standards Requirements
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 concepts of a reference architecture for lab integration and a laboratory data framework which is based on open standards.

Vince Woodall
limsQC.com
In the year 2525...  A brief look at technology trends
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.

David Stokes
Venostic
From Paper to the Cloud – Minimising the Risk
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.
Dan Chapman
Waters
Improving Efficiency in Laboratory Sample Management
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.
Jan Verelst & Patrick Bossuyt
Siemens
Integrated Quality from Design to Manufacturing
  • Applying Collaborative manufacturing
  • Shifting from Quality by Inspection to Quality by Design
  • Tearing down  the wall between R&D and manufacturing
Steve Yemm
Core Informatics
The Next Generation R&D Cloud to Integrate and Maximise the Value of Scientific Data
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.
Annemarie Braber
Nizo Food Research
From Paper to Paperless – More than LIMS with LES
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.
René van Opstal
van Opstal Consulting
Applying ISA-88 in a lab environment
ISA-88 is a worldwide applied standard in the manufacturing industries like Food and Life Science. The standard will set clear definitions for process flow, equipment and automation structures. In his presentation the question is asked if and how this standard can be used in a lab environment.
Peter Balk
NSure
The agile lab: Advantages of lab automation in the cloud
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.
Peter Vijn
The Edge
Five things you always missed in Excel
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.

Burkhard Schaefer
BSSN Software
Delivering Scientific Data Anywhere using the AnIML Data Standard
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.

Peter Boogaard
Industrial Lab Automation
Self-documenting paperless processes to support knowledge management
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