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Computerised Systems in Analytical Laboratories

7 November 2017, 09.00 – 18.00 h


It is the aim of this Conference to discuss the different applications of LIMS, ELN, LES, SDMS, PLM, ERP, etc. and to show how LIMS can be implemented in today’s QC and R&D environment. Technical issues will also be addressed, e.g. how to connect analytical instruments, or how to link Electronic Laboratory Notebooks (ELNs) and LIMS.

This year the current data integrity challenges in analytical labs will especially be addressed: which are the actual regulatory expectations (WHO, MHRA and FDA) and how to implement cGMP compliant data record management systems in practice.

The challenges of Audit Trail Reviews and how to implement these controls in a practical manner will be another focus area of this course. And a paperless laboratory case study will show how paperless processes are a key to achieve Data Integrity compliance. A team of experienced speakers will provide you the opportunity to learn more about their practical experiences and to discuss possible pitfalls and how to avoid these.


The paperless laboratory has been a dream in QC and R&D for a number of years. It offers the possibility to improve and accelerate the analytical processes in the laboratory on one hand, and to save money and costs on the other hand.

The power of a paperless lab is the ability to enable organizations to implement self-documenting processes that produce GxP-compliant documentation which eliminates unnecessary tasks from the workflow, resulting in a significant reduction of the cost of non-compliance and optimization of the corporate Cost of Goods Sold (COGS).

But the integrity and security of laboratory data, records, results, and information is fundamental for running a successful GMP regulated QC laboratory. This applies for the classic analytical lab as well as for microbiology or other labs both, for in-house labs or contract labs.

To develop a secure, stable and “validable” laboratory information management system (LIMS) - maybe even compatible with an already existing system - is a real challenge for LIMS suppliers. And the successful implementation and validation of a LIMS in compliance with GAMP and GMP requirements (EU Annex 11, US 21 CFR Part 11, PIC/S, etc.) is a huge challenge for all pharmaceutical QC and R&D departments.

Topics that will be addressed are:

  • A risk-driven Approach to Data Integrity
  • Regulatory Requirements Update (EU and US)
  • Competing in a Data-driven World - Transforming Scientific Information into Actionable Insights
  • Audit Trail Review
  • Case Study: Entering the Paperless and Digital Era @ UCB BioPharma
  • Case Study: Validation of a global Lab Execution System
  • How Informatics will enable better Quality - One Process, one Record Solution

Target Audience

This conference is aimed at the following attendees:

  • Laboratory personnel working in GMP laboratories in the pharmaceutical industry, contract research organisations, contract manufacturing organisations and API manufacturers
  • Employees involved in the implementation and use of LIMS
  • Quality Assurance /Quality Control (Quality Manager, Quality Systems Project Leader, Laboratory Head, QA Director)
  • Lab Information Management
  • ELN and LIMS Project Leader
  • IT, Informatics and Support
  • LIMS Suppliers


A risk-driven Approach to Data Integrity (Key Note Presentation at the Plenum)
Niek Janssen, ALTRAN Netherlands
According to the latest data integrity guidelines firms should implement meaningful and effective strategies to manage their data integrity risks based upon their process understanding and knowledge management of technology and business models. This key note presentation will provided a practicable risk management approach to ensure data integrity throughout the data life cycle.

Regulatory Requirements Update (EU and US)
Peter J. Boogaard, Industrial Lab Automation, The Netherlands

  • Importance of a Laboratory Data Governance policy
  • Update of regulatory requirements FDA and EU
  • Strategies how laboratory data standards may support reduction of validation efforts

Audit Trail Review
Niek Janssen, ALTRAN Netherlands

  • Why are audit trails so frequently mentioned in regulatory observations?
  • What are the true challenges of meeting current regulatory audit trail expectations?
  • Which controls are required at a minimum to review audit trails?
  • How to implement these controls in a practical manner ?
  • Can audit trails also serve other purposes?

Competing in a Data-driven World - Transforming Scientific Information into Actionable Insights
Peter J. Boogaard, Industrial Lab Automation, The Netherlands

  • Are we ready to adopt Internet of Lab Things in a regulatory setting (IoLT)?
  • What can we learn from a “smart factory” concept in science? Impact of industry 4.0 for lab operations
  • Will Q10 help as a guideline to apply new approaches for data integrity and data governance?
  • Impact of data creator’s vs data consumer’s mind-set. Learnings from other industries
  • Examples of automated self-documenting data capture processes in data lifecycle to reduce DI effort
  • New approaches to use audit trail as source to improve operational excellence

Case Study: Entering the Paperless and Digital Era @ UCB BioPharma
Eric De Maesschalck, UCB, Braine, Belgium

  • The challenge of simultaneous implementation of several ELNs : ensuring efficient paperless data flows through proper systems integration
  • Improving laboratory efficiency by: direct data capture from equipment, automatic check of reagents and solutions at analysis time and self-documenting processes
  • Streamlining communication between laboratory and manufacturing area: designing real time bi-directional data transfer
  • Integrating new technologies: smartphone apps, Kinect technology, Google Glass: what did not work and what was a success?
  • Paperless processes: a key to demonstrate compliance to Data Integrity Requirements
  • What’s next : IoT (Internet of Things)?

Case Study: Validation of a global Lab Execution System
Christophe Girardey, wega Informatik

How Informatics will enable better Quality - One Process, One Record, One Solution<
Robert Lutskus, Lonza

  • How to waste less time in coordinating and reviewing data from multiple sources
  • Faster Release by combining lab information and production records
  • New approaches to workflow and role-based analytics
  • How to apply technology trends and integration approaches required to achieve this vision


Peter J. Boogaard
Industrial Lab Automation, The Netherlands


Peter J. Boogaard, Industrial Lab Automation, The Netherlands
Founder Industrial Lab Automation. Member of the ISPE GAMP community.

Christophe Girardey, wega Informatik AG, Switzerland
Christophe Girardey manages the group CSV & QA at Wega Informatik. He is involved in different Lab Systems Projects (Lab Execution System, LIMS, …) as Validation Lead or Business Analyst accross Switzerland and Germany.

Niek Janssen, ALTRAN Netherlands
Life Sciences Consultant with strong background Computerised System Validation (CSV) and Industrial IT.

Eric De Maesschalck, UCB, Belgium
Head of Global e-Analytics, Corporate Analytical Sciences.

Robert Lutskus, Lonza, USA
Global Product Delivery Manager for MODA™ EM.