Event Organizer: Labbit
Event Overview:
Most LIMS platforms treat 21 CFR Part 11 compliance as a checkbox exercise—capturing change events, logging user actions, and binding electronic signatures in a relational database. But compliance isn’t just about storing data; it’s about demonstrating trust, traceability, and intent behind every record.
In this webinar, we’ll explore how traditional relational systems—while technically compliant—often fall short of delivering a clear, audit-ready narrative. We’ll show how Labbit’s graph-based architecture reimagines electronic records as immutable, revisioned nodes that inherently preserve context, meaning, and purpose. From workbook drafts to final signature events, our model doesn’t just log actions—it tells the story of how a result came to be.
We’ll cover:
– What Part 11 really says about electronic records and electronic signatures
– The problem with field-level auditing during draft states
– Why audit trail usability matters just as much as audit trail completeness
– How a graph database naturally enforces ALCOA+ principles
Whether you’re in Quality, IT, or Lab Operations, you’ll leave with a deeper understanding of how modern architecture can reduce compliance risk, improve usability, and give auditors confidence—without over-engineering your system.
Presented by: Brian Jack, COO of Semaphore Solutions and Meghan Bowman, Senior Product Manager for Labbit
