Last updated: February 11,  2025.
 

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At Hoodin, we are committed to transparency and responsible use of artificial intelligence (AI) in regulatory intelligence and compliance monitoring. Our AI-powered system is designed to support Regulatory Affairs and Quality Assurance (RAQA) professionals by enhancing efficiency, accuracy, and decision-making.
 

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AI as a Supportive Tool – User Control First

 

The foundation of our AI policy is clear:

• AI is always and only used to generate suggestions – It does not make final decisions.

• Users always have full control – They can reject, edit, or accept AI-generated proposals as they see fit.

• Transparency is key – Every AI-generated suggestion is clearly marked, ensuring users understand that it comes from a trained AI model.

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Understanding AI in Hoodin

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• Data-Driven Insights – Our system utilises AI-powered tools to analyse vast amounts of regulatory data and deliver actionable intelligence, helping users stay compliant with evolving regulations.

• Automation of Routine Tasks – AI streamlines information gathering, categorisation, and summarisation, allowing users to focus on strategic decision-making.

• AI-Assisted Compliance Monitoring – The AI identifies and tracks regulatory changes, providing structured insights on amendments, proposals, and emerging trends.

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AI Transparency & User Control

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• Decision Support, Not Decision Making – Hoodin’s AI-enhanced tools assist in regulatory workflows but do not replace human judgment. Users should validate AI-generated insights before making compliance decisions.

• Source-Based Analysis – Our AI-powered tools process data from verified regulatory sources, ensuring reliability. Each AI-generated insight includes references to original documents.

• Continuous Learning & Improvement – We continuously update and refine our AI integrations to improve accuracy, adaptability, and alignment with regulatory standards.

 

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Ethical & Responsible AI Use

 

Hoodin follows strict guidelines for data integrity, fairness, and reliability when using AI-powered technologies in regulatory intelligence. We are

committed to:

• Avoiding Bias – The AI tools we use are designed to provide objective regulatory insights without bias.

• Protecting User Privacy – AI analysis is conducted in compliance with data protection regulations and industry best practices.

• Ensuring Explainability – We prioritise transparency so that users understand how AI-generated insights are produced.

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Regulatory Alignment

 

Hoodin aligns with emerging AI governance frameworks, including:

• EU AI Act – We follow risk-based principles ensuring transparency, human oversight, and regulatory compliance in AI-powered insights.

• FDA AI Guidance – Our AI-driven tools support regulatory intelligence for life sciences in accordance with the FDA’s AI and Machine Learning principles.

• Global AI Best Practices – We continuously monitor evolving AI regulations and adapt our approach to align with industry and legal requirements.

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Your Role in AI Literacy

 

To maximise the value of AI-powered compliance monitoring, we encourage Hoodin users to:

• Review AI-generated insights critically and validate key findings against primary sources.

• Engage with AI recommendations proactively and provide feedback to enhance system performance.

• Stay informed on evolving regulatory landscapes and how AI assists in managing compliance.

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Hoodin’s AI-enhanced tools are built to empower RAQA professionals, providing clarity and efficiency while ensuring control remains with the user.

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For further information, please contact Hoodin via the contact form at https://www.hoodin.com/contact

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Hoodin AB
Humlegatan 4
211 27 Malmö, Sweden

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