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

Event Overview

Laboratory Information Management Systems (LIMS) have advanced significantly beyond basic sample tracking. In modern pharmaceutical and biotech settings, LIMS must not only maintain data integrity but also serve as the core of laboratory automation and a vital element of broader manufacturing systems. They support compliance with ALCOA+ principles and facilitate integration with ERP, MES, and QMS systems, ensuring both laboratory accuracy and enterprise data connectivity.

This Expert Forum brings together industry professionals to exchange practical insights, experiences, and lessons learned on implementing and optimising LIMS — highlighting their role as guardians of data integrity and fundamental components of the digital manufacturing landscape.

PART 1: Beyond Sample Tracking – LIMS as the Backbone of Laboratory Data Integrity

This session focuses on the evolution of LIMS from paper-based tracking tools to full-fledged data management systems. It explores how LIMS ensure compliance, reduce human error through automation, and support trustworthy, audit-ready laboratory data.

Objective:
To demonstrate how LIMS provide a foundation for reliable, compliant, and future-ready laboratory operations.

Topics:

• Evolution of LIMS: from sample tracking to digital data management
• Data integrity and ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available)
• Standardisation, traceability, and audit trails for compliance (ISO, GxP, FDA, EMA)
• Practical compliance examples: manual records vs. secure digital records
• Implementation challenges: change management, legacy integration, data migration
• Success factors: clear objectives, phased rollout, training, stakeholder adoption
• Looking ahead: cloud-based LIMS, AI-driven QC, IoT-enabled instruments, predictive analytics
  

PART 2: LIMS as Part of the Manufacturing Application Landscape

The second session expands the scope from the laboratory to the full manufacturing context. It highlights how LIMS interact with enterprise systems to ensure seamless data flows, efficient operations, and robust quality management.

Objective:
To position LIMS within the broader manufacturing IT ecosystem, showing its role as a central link between laboratory, production, and enterprise systems.

Topics:

• LIMS/ELN as the backbone of laboratory automation in Development and QC
• Integration with the supply chain via ERP: monitoring incoming goods, intermediates, and finished products
• Raw data management and long-term archiving
• LIMS and QMS: SOP management, change control, and complaints handling
• Interfaces with Manufacturing Execution Systems (MES), Process Control Systems (PCS), and sensors
• Time-based data sources and historians for process monitoring
• Enterprise management information: linking pilot batches, manufacturing, and development
• Data warehouses for KPI tracking and management insights
• ISO 95 levels and the role of LIMS in the layered application landscape

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’.
• If you’re unable to join the live broadcast, register anyway, and we’ll send you the recording.
• 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