Navigating your path to success: Real-life examples of how large enterprises set up their LIMS for success (CTEC highlights)

Date: 27 November 2024

Time: 4 PM CET/10 AM ET

Language: English

Duration: 2 Hours

Abstract:

In today's data-driven laboratory environments, large enterprises face complex challenges in managing vast amounts of labs, maintaining operational efficiency, and ensuring regulatory compliance. Join us for an exclusive session where we highlight key presentations from the recent CTEC EMEA, featuring the success stories of five leading global organisations that have successfully implemented LIMS on an enterprise-wide scale. We will explore the implementation strategies, success factors, and approaches to driving user adoption, all of which have transformed their lab operations. Whether you're considering implementing a LIMS or looking to optimise your current system, this session offers valuable insights to guide your journey.

Broadcast Agenda:

4:00 PM CET / 10:00 AM ET | Enriching LIMS Data with MetaData – an Enabler for the Flexible, Automated Laboratory
Speaker - Henrik Behrndt, Senior Product Architect, Novo Nordisk

When automating laboratory processes, the robots and equipment need structured information, that previously was present as unstructured data. Procedural details may be available from documents like SOP, Instructions, mails, post-it notes or even by the lab technicians knowing. When we initially started our laboratory automation journey, we had a list of 119 potential system modifications to our LabVantage LIMS system that all aimed at structuring the unstructured data. Instead of working by the list of requirements we developed a generic framework, that can be applied to any piece of data in LabVantage. With this approach, we reduced 119 system change requirements into development of one solution, that could meet all of the requirements.

4:30 PM CET / 10:30 AM ET | How Novo Nordisk Has Configured LIMS to Support Their Daily Operation
Speaker - Lone Bladt Norden, Christian Gamsgaard, Ulrika Krus, Hanne Orlof Mogensen, Novo Nordisk

Novo Nordisk is using LabVantage LIMS (globalLIMS) in all our production sites and R&D areas across 8 countries with more than 10.000+ users globally. Our globalLIMS system is a core system in our strive to lean and automate all our laboratory processes across the whole value chain. Out of the box functionalities are used together with dedicated solutions for additional requirements.

5:00 PM CET / 11:00 PM ET | Unleashing Potential: Richter BioLogics Strategic Shift to LIMS in QC Labs 
Speaker - Marko Gentzsch & Alexander Junemann, Richter BioLogics 

Richter BioLogics has developed a comprehensive vision for QC lab activities, utilizing LabVantage LIMS to transition into a paperless environment. Our phased implementation strategy prioritizes user needs and minimizes customization, showcasing a practical approach to technological adaptation. Notably, the Batch Management module of the LIMS has been significantly adapted to manage all lifecycle activities of physical containers used in the QC labs and to improve data integrity. The initial success of the project is evident in the considerable value already generated and the positive user feedback, promising a bright future for further optimizations and extensions.

5:30 PM CET / 11:30 PM ET | Leverage Your QC Operational Efficiency Through Digitalization of Environmental Monitoring
Speaker - Ylhem Logon, Environmental Monitoring Global Marketing Manager, Biomerieux 

In today’s pharmaceutical industry, there is a myriad of GMP data being generated in the field of environmental monitoring. This is a challenge, knowing the increasing demands for additional testing. The new EU annex 1 further increases the requirement for improved data integrity to ensure that facilities are maintained in a state of GMP compliance. Data integrity is not restricted to electronic records and electronic signatures (as described in CFR 21 Part 11); it should be considered as a holistic and consistent approach, taking into account the role of people, processes, and technologies. In this presentation we will explore the data integrity principles and discuss how the automation and digitalization of the Environmental Monitoring (EM) process allows a facility to:

• have better control of manufacturing
• secure product safety, mainly related to pharmacovigilance
• eliminate low value, manual, error-prone tasks
• Increase the confidence of regulatory agencies in facility’s quality systems by strengthening the approach to data integrity