Key Learning Outcomes
- Understand how LIMS establishes complete traceability throughout the sample lifecycle, linking every action, user, and timestamp to support compliance and streamline audits.
- Learn how LIMS enforces ALCOA+ principles to protect data integrity, eliminate manual errors, and maintain accurate, trustworthy records throughout the data lifecycle.
- Discover how LIMS addresses regulatory compliance gaps through electronic signatures, audit trails, role-based access controls, and automated alerts for out-of-specification results.
- Explore the role of validation and automated testing in maintaining LIMS reliability during system upgrades, ensuring consistent performance and regulatory readiness.
Event Overview
This presentation examines the critical challenges laboratories face without a LIMS and demonstrates how implementing one transforms operations by enhancing traceability, data integrity, and compliance. Melanie explores how LIMS provides end-to-end visibility of the sample lifecycle, captures every action with secure audit trails, and enforces ALCOA+ principles to eliminate common risks like missing entries and human error.
The session covers validation fundamentals using the GAMP framework and explains how validation establishes documented evidence that your system consistently performs as intended. We’ll demonstrate why validation isn’t just a regulatory requirement but a sound business practice that helps identify defects before go-live and maintains systems in a validated state throughout their lifecycle.
Finally, Melanie discusses how automation strengthens LIMS reliability through master data verification and regression testing during upgrades. Automated scripts validate large datasets for accuracy and quickly verify core workflows, minimising downtime and ensuring updates don’t disrupt critical laboratory operations. Whether managing a small lab or a global network, these principles apply across the board.
Who Should Attend?
Anyone involved in laboratory operations, quality management, validation, and regulatory compliance who wants to understand how LIMS solves critical challenges in traceability, data integrity, and compliance.
- Laboratory Managers and Directors
- Quality Control and Quality Assurance Professionals
- Validation and Compliance Specialists
- Laboratory Information Systems Administrators
- Regulatory Affairs Professionals
- Scientific and Technical Managers overseeing laboratory operations
Unlock Additional Educational Resources
Register for Melanie’s presentation today and enjoy access to exclusive bonus content, including the insightful panel discussion on “Beyond Sample Tracking – LIMS as the Backbone of Laboratory Data Integrity”.
