1. Connexo Quality News
AI-Powered Insights: How Can AI Summarize and Classify Quality Data?
As life sciences organizations generate more quality data than ever, automation has become essential. QualityWise.ai, CONNEXO’s intelligent automation solution, uses advanced AI to classify quality events, identify patterns, and generate clear summaries for informed decision-making.
Key capabilities include:
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Pattern recognition across non-conformances and incidents
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Natural language summarization of complex quality documents
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Auto-tagging and smart linking within QMS environments
These features help teams focus on prevention and continuous improvement by transforming raw data into actionable intelligence.
🔗 Learn more about QualityWise.ai
2. FDA & Regulatory Updates
📍 FDA Reorganization: Unified Human Foods Program Now Live
In October 2024, the FDA launched a significant reorganization that includes:
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Renaming the Office of Regulatory Affairs to the Office of Inspections and Investigations (OII)
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Establishing the Human Foods Program, integrating food safety, nutrition, and inspections
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Adopting a future-ready structure with focus on AI, food technologies, and global oversight
These changes reflect the agency’s modernization goals to align regulatory operations with emerging risks and innovations.
📍 QP Declaration Q&A – Now at Revision 8
In April 2025, the CMDh and CMDv released an updated Q&A on Qualified Person (QP) Declarations, now at Revision 8.
What’s new:
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Clearer guidance on updating QP declarations under Chapter F variations
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Veterinary-specific content removed to improve focus and usability
This update helps ensure better compliance alignment during EU submissions.
🔗 Read the updated Q&A document
3. Connexo News
CONNEXO to Join RQA’s 2025 European QA Virtual Conference
From May 20 to 22, 2025, CONNEXO will participate in the Research Quality Association (RQA)’s fully virtual European QA Conference, bringing together global quality experts across GxP domains.
Conference themes include:
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The role of AI in quality assurance
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Implementation strategies for ICH E6(R3) and the EU AI Act
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GxP data integrity and digital transformation frameworks
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Leadership skills for audit communication and team management
The event will also feature a keynote from Honeywell Life Sciences, offering insights into innovation and compliance in the digital era.
🗓️ Dates: May 20–22, 2025
🌐 Format: 100% Virtual
🔗 View the full agenda and register
Inquiries & Demo Requests
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