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Computerised Systems in Analytical Laboratories

7 November 2017

Objectives

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?

Effective LIMS validation will be another focus area of this course. A paperless laboratory case study will show how close analytical labs can get there today. 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.

Background

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. br>
Topics that could be addressed are:

  • Similarities, differences and potential of different applications like LIMS, ELN, SDMS, PLM, ERP, etc.
  • Regulatory Requirements
  • Importance of Laboratory Data Integrity
  • How to connect analytical instruments
  • Preparing a paperless lab project
  • Standardization: S 88, raw data management, etc.
  • ELNs (Electronic Laboratory Notebooks) Leveraging Analytical Instrument Qualification (AIQ) for Computerised System Validation (CSV)
  • Approaches to apply data analytics to laboratory processes
  • Strategies to adopt the “smart factory" concept in lab operations. including how and if Industry V4.0 strategies can be applied to laboratory operations

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

Programme

A risk-driven Approach to Data Integrity (Keynote Presentation)
Niek Janssen, Astellas Pharma Europe
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, Astellas Pharma Europe

  • 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?

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)?

From Sample to Decision: Role of Informatics in Laboratory Workflows
Dr Ruud Verpoort, Waters, NL

  • Typical flow of a sample through the lab
  • Data integrity including ALCOA+
  • Impact of false data, not meeting data integrity requirements
  • Difference between data back up and archiving, and the importance of this

How Informatics will enable better Quality - One Process, one Record Solution
Robert Lutzkus, 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

Moderator

Peter J. Boogaard
Industrial Lab Automation, The Netherlands

Speakers

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

Niek Janssen, Astellas Pharma Europe
Validation, industrial automation and information Management.

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

Dr. Ruud Verpoort, Waters, The Nederlands
European Informatics Business Development Manager.

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