1. Connexo Quality News
How Can AI Summarize and Classify Quality Data?
Spotlight on QualityWise.ai
As the volume of quality data continues to grow, the importance of automated analysis and intelligent insight has become critical.
Connexo’s QualityWise.ai leverages AI to classify quality events, recommend CAPA priorities, and detect recurring issues.
Key Capabilities:
- Pattern recognition across incidents
- Natural language summary of quality documents
- Auto-tagging linked with QMS
https://www.connexo.io/products/honeywell/qualitywise
Warning Letter at a Glance
2. FDA & Regulatory Updates
๐ FDA Reorganization – Unified Human Foods Program Now in Effect
As of October 2024, the FDA launched a major reorganization including:
- Rebranding of the Office of Regulatory Affairs → Office of Inspections and Investigations (OII)
- Launch of the Human Foods Program integrating food safety, nutrition, and inspection
- A future-ready structure for AI, global supply chain oversight, and food technologies
๐ https://www.fda.gov/about-fda/fda-organization/fda-modernization-efforts-establishing-unified-human-foods-program-new-model-field-operations-and
๐ QP Declaration Q&A – Updated to Revision 8
CMDh and CMDv updated their joint Q&A on QP Declarations in April 2025.
Key Changes:
- Clarified rules for submitting updated declarations in Chapter F variations
- Veterinary medicine-specific guidance was removed for clarity
๐ https://www.gmp-compliance.org/gmp-news/q-a-document-on-qp-declaration-updated
3. Connexo News
RQA’s 2025 European QA Virtual Conference – May 20–22
Hosted by the Research Quality Association (RQA), this fully virtual event gathers global quality professionals for interactive sessions and keynotes.
Highlights Include:
- AI in quality assurance
- ICH E6(R3), EU AI Act strategies
- GxP data integrity & digital transformation
- Leadership & communication in audits
- Keynote from Honeywell Life Sciences
๐๏ธ Dates: May 20–22, 2025
๐ Format: 100% Virtual
๐ https://www.therqa.com/learn-develop-connect/courses-and-events/conferences/2025-european-qa-virtual-conference/
๐ฉ Inquiries & Demo Requests:
[email protected] / www.connexo.io