Beyond Sample Tracking – LIMS as the Backbone of Laboratory Data Integrity

Sponsorship opportunities are available for this event. Please contact Dean Graimes or Jeroen Reiniers for more information.

Event Overview

Laboratory Information Management Systems (LIMS) have evolved beyond basic sample tracking. In today’s Good Practice (GxP)-regulated environments, LIMS are expected to enforce data integrity, drive automation, and serve as a central hub for laboratory data. However, implementation is complex, validation is critical, and integration with other systems often poses significant challenges.

This Expert Forum brings together industry experts to share their insights, experiences, and practical strategies for successfully deploying and optimising LIMS in pharmaceutical and biotechnological quality control laboratories.

PART 1: Implementing and Validating LIMS in GxP Laboratories

This session focuses on best practices for selecting, configuring, and validating a LIMS that meets regulatory requirements. Topics include risk-based validation strategies, GAMP 5 alignment, integration with laboratory systems (e.g., ELN, CDS, QMS), and lessons learned from implementation projects.

Objective:
To provide a structured overview of how a Laboratory Information Management System is selected, implemented, and validated in Good Practice (GxP) regulated environments (e.g., Good Manufacturing Practice – GMP).

Topics:

• Key criteria for selecting a commercial or custom-built Laboratory Information Management System
• Aligning LIMS implementation with Good Automated Manufacturing Practice version 5 (GAMP 5) and risk-based validation strategies
• Managing configuration versus customization for long-term maintainability
• Integration challenges: Electronic Laboratory Notebook (ELN), Chromatography Data System (CDS), Quality Management System (QMS), Enterprise Resource Planning (ERP)
• Project management pitfalls and success factors in regulated environments
• Case study: LIMS deployment in a Good Manufacturing Practice-compliant Quality Control laboratory

PART 2: LIMS for Data Integrity, Integration, and Future-readiness

The second session explores how LIMS can support ALCOA+ compliance, enable automated data capture, and connect with cloud-based and AI-enhanced infrastructures. It also addresses how to future-proof LIMS strategies in an evolving regulatory and technological landscape.

Objective:
To explore the role of LIMS in ensuring data integrity, enabling laboratory automation, and supporting digital transformation initiatives.

Topics:

• ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, and Available) principles and how LIMS supports their implementation
• User access control, audit trails, and electronic signatures in a regulatory-compliant setup
• Instrument interfacing and automated data capture via standardised communication protocols
• LIMS as a data hub: real-time dashboards, structured reporting, and laboratory analytics
• Cloud-based LIMS solutions: validation strategies and regulatory expectations
• Applications of Artificial Intelligence (AI) and Machine Learning (ML) within LIMS-enabled environments

What you need to know:

Dual-time broadcast, with starting times as follows:

PART 1: Wednesday, 19 November 2025

• Broadcast #1 (Europe / Asia): 09:00 h GMT (London) / 10:00 h CET (Paris/Berlin) / 14:30 h IST (New Delhi) / 17:00 h SGT (Singapore) / 18:00 h JST (Tokyo)
• Broadcast #2 (North America / Europe): 08:00 h PST (Los Angeles) / 11:00 h EST (New York) / 16:00 h GMT (London) / 17:00 h CET (Paris/Berlin)

PART 2: Wednesday, 3 December 2025

• Broadcast #1 (Europe / Asia): 09:00 h GMT (London) / 10:00 h CET (Paris/Berlin) / 14:30 h IST (New Delhi) / 17:00 h SGT (Singapore) / 18:00 h JST (Tokyo)
• Broadcast #2 (North America / Europe): 08:00 h PST (Los Angeles) / 11:00 h EST (New York) / 16:00 h GMT (London) / 17:00 h CET (Paris/Berlin)

Duration: Approximately 60 – 90 minutes, incl. Q&A.

• Registrants attending this online event’s live broadcast sessions will receive a ‘Certificate of Attendance’.
• Join the BioQC user community for ongoing discussions after the event.

Who should attend?

• Quality Control (QC) professionals, Quality Assurance (QA), Information Technology (IT) and Computerised System Validation (CSV) specialists, laboratory managers, and regulatory affairs experts