Electronic Laboratory Notebooks
The use of Electronic Laboratory Notebooks (ELNs) technologies continues to grow and expand in their use across the pharmaceutical industry from research to development to quality control laboratories. With the increased focus on data integrity by regulatory agencies worldwide, the importance, as well as the risks associated with the use of these systems, continues to present some unique challenges for users as well as suppliers. This session will provide a unique opportunity for participants to learn from several key suppliers about their products, capabilities, and implementation strategies, as well as hear from industry experts about their experiences with implementing these products in research, development, and quality control environments. Attendees will also have the opportunity to participate in a workshop focused on understanding the risks associated with the use of ELN and identify potential mitigations strategies for improving reliability and compliance with today’s data integrity expectations.
Please click here ( 151 KB) to view the Agenda
This track will include:
Plenary Session: Lifescience Trends and Benchmarking
Introduction to ELN’s
Michael Rutherford, Consultant, Business Systems Support, Development Center of Excellence, Eli Lilly and Company, USA
A Company-wide ELN for Recipe-based Execution in Pharmaceutical Development
Pascal Maes, Principal Engineer Strategic Operations, Johnson & Johnson, Belgium
Janssen Research & Development (Johnson & Johnson) have recently deployed a company-wide ELN with more than 1000 users, spanning discovery, preclinical and development groups. This global ELN deployment includes diverse development areas such as process chemistry, formulation development and analytical characterisation.
Janssen also deployed a LES system to support supply chain activities in clinical release and stability development programmes, with a unique setup using parameterised procedures.
The ELN and LES have become key components in electronic lab environment to support our design-to-value strategies. Advantages include easy access and reuse of data on a global scale, improved paperless tech transfers, simplified submissions of files for approval by regulatory authorities, and thus faster and more efficient introduction of new products to the market.
One of the major goals was to help standardise the various development activities based on common recipe data models and recipe development tools (based on ISA-88). As such, the ELN has become the key enabler of a recipe-based data warehouse.
Demonstrating Traceability of Data, Results, and Observations by Using ELN for Laboratory Execution
Heather Longden, Informatics Solution Consultant Team Manager Europe, Waters Ltd, United Kingdom
The presentation will show how an ELN designed for both free flow and Laboratory Execution, suitable for use in a development laboratory, can be used to create permanent links between records, even between data from disparate software solutions. This greatly eases the analytical burden of requiring defined , but manually entered, metadata for traceability purposes. As well as automated validated data and meta data transfer between different documents or even completely separate applications, the ability to follow the links backwards, from result to raw data, can greatly simplify the review process.
Case Study: The Use of Nugenusis in Product Research and Development
Karen McCune, Senior Research Scientist, Eli Lilly & Co, USA
The Convergence of Automation IT Systems in R&D and cGMP QC/QA Environments
John Helfrich, Senior Director, Accelrys Inc.,USA
Today, innovative life science companies, are looking at the next decade and actively planning to harmonise their global R&D and cGMP IT systems. The goals are to gain significant productivity improvements, dramatic cost reductions and improved infrastructure dynamics by minimising the number of supported “systems” through a clear and compelling convergence strategy. In many companies this results in a three tier structure with SAP, a commercial LIMS and ELNs. For some, it is an elimination of the LIMS layer all together by utilising the QM module of SAP and the administration modules in the ELNs. Either way, reported results include 20%+ cost/productivity improvements, 50%+ cycle time reductions, the elimination of paper in the process and assured compliance documentation.
This paper will outline the key issues facing the R&D and Quality cGMP environments and presents key IT-based solutions that have been implemented by leading pharma and biotech companies. Key regulatory and industry initiatives on QbD and technology transfer from R&D to manufacturing will be outlined. This technology solution represents a convergence of traditional LIMS designs/functions and purpose-built research and cGMP ELN designs/functions.