Learn how LIMS functions as a workflow system within the laboratory

Key Learning Outcomes

• Understand how LIMS fits into the broader application landscape for pharmaceutical manufacturing organisations, using an ISA-95 layered architecture to map the relationships between development and QC laboratories, manufacturing operations, and enterprise systems.
• Learn how LIMS functions as a workflow system within the laboratory, covering sample registration, preparation, testing, result validation, approval, reporting, and archiving, and how integration with ERP systems connects laboratory operations to the wider supply chain.
• Discover the role of raw data management and scientific data management tools in securing instrument-generated data across the application landscape, and why reliance on local instrument storage presents a significant data integrity vulnerability.
• Explore how manufacturing execution systems, process control systems, data historians, and enterprise manufacturing intelligence layers work together to capture, manage, and consolidate time-based sensor data from manufacturing operations alongside laboratory results.

Event Overview

This session offers a practical, systems-level overview of how LIMS fits within the complete application landscape of a pharmaceutical manufacturing organisation. Drawing on extensive experience across pharma, biotech, contract laboratories, and water testing environments, the presenter employs the ISA-95 layered architecture as a structured framework for illustrating how data moves between instruments, laboratory systems, manufacturing systems, and enterprise platforms.

The presentation begins with the development and QC laboratory side of the landscape. LIMS is positioned as the central workflow system for the laboratory, optionally integrated with an electronic laboratory notebook to support electronic data capture at every stage from sample reception to archiving. The vital connection between LIMS and the ERP system is established early, emphasising that LIMS is not a standalone tool but an essential part of the supply chain, receiving sample and product information from ERP and returning results to it.

It then highlights the often-overlooked issue of raw data management. Instrument software often stores data locally on workstation hard drives rather than on backed-up network locations, creating vulnerability in the data chain. Scientific data management tools are introduced as the solution and are shown as vertical elements in the ISA-95 model because they span both the instrument and laboratory layers. The connection between LIMS and the quality management system is also discussed, including document management, change control, and complaint handling at the enterprise level.

The session then shifts to the manufacturing operations side of the landscape. Here, the key systems include process control systems and sensors at the factory floor level, a manufacturing execution system that connects recipes and batch records to the ERP layer, and data historians for managing the high-volume time-series data generated by manufacturing sensors. The distinction between laboratory data and manufacturing sensor data is clearly drawn, with LIMS regarded as unsuitable for time-based sensor data and data historians introduced as the suitable solution for both manufacturing and laboratory sensor environments.

The session concludes by introducing the enterprise manufacturing intelligence layer and data warehouse as mechanisms for consolidating information from all these systems into a single, coherent view, facilitating reporting and analytics through tools such as Power BI.

Who Should Attend?

Anyone responsible for laboratory informatics, manufacturing systems, or digital infrastructure in a pharmaceutical or biotech organisation seeking a clear, structured understanding of how LIMS integrates with the broader application landscape.

• Laboratory Information Systems Administrators
• Laboratory Managers and Directors
• IT and Digital Transformation Specialists supporting laboratory and manufacturing environments
• Quality Control and Quality Assurance Professionals
• Manufacturing Operations and Process Technology Specialists
• Validation and Compliance Scientists
• Scientific and Technical Managers overseeing laboratory and manufacturing operations

Unlock Additional Educational Resources

Register today for Paul’s presentation and gain access to exclusive bonus content, such as the insightful panel discussion on “LIMS as Part of the Manufacturing Application Landscape”.

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