Volume 28 covers AI tools for quality records, regulatory organization and guidance updates, and Connexo’s plans to attend the RQA European QA Virtual Conference.
AI support for quality records
QualityWise.ai helps quality teams classify events, identify patterns across non-conformances and incidents, and produce summaries of complex records. Auto-tagging and links between related records can make information easier to find and review within a QMS.
These functions support the work of reviewing quality data and investigating recurring issues. Learn more about QualityWise.ai.
FDA organization and QP declaration guidance
The FDA’s October 2024 reorganization established a unified Human Foods Program and renamed the Office of Regulatory Affairs as the Office of Inspections and Investigations. The changes reorganised responsibilities for food oversight and field operations.
Read the FDA’s overview of the reorganization.
Revision 8 of the QP declaration questions and answers is also covered in this issue. The revision addresses updates to declarations under Chapter F variations and removes veterinary-specific material.
Read the update on QP declaration guidance.
RQA European QA Virtual Conference
Connexo will participate in the Research Quality Association’s European QA Virtual Conference on May 20–22, 2025. The online program covers AI in quality assurance, ICH E6(R3), the EU AI Act, GxP data integrity, and digital transformation.
Sessions will also address audit communication and team leadership. Honeywell Life Sciences is scheduled to give a keynote presentation.
For inquiries, contact [email protected].