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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.

Topics that could be addressed are:

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