Backlog Burnout? Ask about our Services.

Backlog Burnout? Ask about our Services.

NEW

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Resolve Deviations Faster

AI-Powered Deviation Management for Life Sciences
Dramatically Accelerate Your Path from Investigation to Resolution

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When Quality matters, let Qwyn AI help.

When Quality matters, let Qwyn AI help.

Platform

As Quality evolves, systems must transform.

Quality demands are rising faster than ever. Traditional QMS struggle to adapt—Qwyn AI is here to help.

Platform

As Quality evolves, systems must transform.

Quality demands are rising faster than ever. Traditional QMS struggle to adapt—Qwyn AI is here to help.

Smart Planning

Transform deviation management from reactive to revolutionary. Our platform instantly analyzes your data, builds risk-based investigation plans keeping you ahead of regulatory requirements. Your teams knows exactly what to work on, finding root causes and resolving issues quickly—because that's what matters.

Automated Risk Analysis

Enhanced Decision Making

Guided Interface

Cross-Team Collaboration

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Guided Analysis & Investigation

Accelerate product releases while strengthening quality assurance by automating routine investigation tasks, standardizing best practices, and maintaining a complete audit trail that satisfies regulators and keeps your products moving to market.

Guided Investigation

Trend Detection

Enhanced Audit Trail

Regulatory Checks

Document Automation

Automate investigation reports with AI that intelligently structures findings and ensures compliance with your SOPs. Our system verifies documentation against known regulatory actions, strengthening risk assessment while maintaining complete audit trails. Generate comprehensive, compliant reports in minutes—not days—so your teams can focus on resolution rather than documentation.

Automated Verfication

Accelerate Approvals

Standarize Reporting

Enhanced Agility

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Flexible

Redefining Modern Quality Systems

Seamlessly adapts to how you work - whether as a standalone solution or integrated with your current systems, you'll be up and running fast without disrupting your proven processes.

Flexible

Redefining Modern Quality Systems

Seamlessly adapts to how you work - whether as a standalone solution or integrated with your current systems, you'll be up and running fast without disrupting your proven processes.

Rapid Implementation

Rapid Implementation

Deploy in weeks, not months. Our agentic AI learns your quality processes and adapts to your workflows without extensive configuration—accelerating your path to productivity.

Deploy in weeks, not months. Our agentic AI learns your quality processes and adapts to your workflows without extensive configuration—accelerating your path to productivity.

Built for Life Sciences

Built for Life Sciences

Optimized for life sciences, our AI platform delivers quality solutions tailored to Life Sciences manufacturing's unique regulatory landscape.

Optimized for life sciences, our AI platform delivers quality solutions tailored to Life Sciences manufacturing's unique regulatory landscape.

Security Focused

Security Focused

Our security-focused architecture protects your critical quality data while aligning with FDA, EU GMP, SOC 2, and ISO requirements for regulated environments.

Our security-focused architecture protects your critical quality data while aligning with FDA, EU GMP, SOC 2, and ISO requirements for regulated environments.

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BENEFITS

Built by Quality, for Quality!

Say goodbye to manual tasks and hello to efficiency, automation, and smarter decision-making with the Qwyn AI Quality Platform.

BENEFITS

Built by Quality, for Quality!

Say goodbye to manual tasks and hello to efficiency, automation, and smarter decision-making with the Qwyn AI Quality Platform.

Backlog Breakthrough

Eliminate quality investigation backlogs with intelligent automation. Our AI prioritizes critical issues and accelerates routine reviews—transforming overwhelming backlogs into manageable workloads while maintaining compliance.

Backlog Breakthrough

Eliminate quality investigation backlogs with intelligent automation. Our AI prioritizes critical issues and accelerates routine reviews—transforming overwhelming backlogs into manageable workloads while maintaining compliance.

Backlog Breakthrough

Eliminate quality investigation backlogs with intelligent automation. Our AI prioritizes critical issues and accelerates routine reviews—transforming overwhelming backlogs into manageable workloads while maintaining compliance.

Reduce Cycle Time

Reduce cycle times from weeks to days. Our AI analyzes patterns, prioritizes critical issues, and suggests proven solutions—helping you release compliant products faster while maintaining the highest quality standards.

Reduce Cycle Time

Reduce cycle times from weeks to days. Our AI analyzes patterns, prioritizes critical issues, and suggests proven solutions—helping you release compliant products faster while maintaining the highest quality standards.

Reduce Cycle Time

Reduce cycle times from weeks to days. Our AI analyzes patterns, prioritizes critical issues, and suggests proven solutions—helping you release compliant products faster while maintaining the highest quality standards.

Trend Detection

Identify emerging quality patterns before they become systemic problems. Our AI continuously analyzes deviation data across your manufacturing network, alerting you to developing trends that prevent costly escalations.

Trend Detection

Identify emerging quality patterns before they become systemic problems. Our AI continuously analyzes deviation data across your manufacturing network, alerting you to developing trends that prevent costly escalations.

Trend Detection

Identify emerging quality patterns before they become systemic problems. Our AI continuously analyzes deviation data across your manufacturing network, alerting you to developing trends that prevent costly escalations.

Institutional Memory

Never lose critical quality insights again. Our AI preserves your team's investigation knowledge, maintains consistency through staff transitions, and prevents recurring issues by remembering every solution your experts have developed.

Institutional Memory

Never lose critical quality insights again. Our AI preserves your team's investigation knowledge, maintains consistency through staff transitions, and prevents recurring issues by remembering every solution your experts have developed.

Institutional Memory

Never lose critical quality insights again. Our AI preserves your team's investigation knowledge, maintains consistency through staff transitions, and prevents recurring issues by remembering every solution your experts have developed.

Strategic Focus

Direct resources where they matter most. Our AI intelligently scores deviations based on product impact probability, helping your teams tackle critical issues first while efficiently handling routine cases with proven approaches.

Strategic Focus

Direct resources where they matter most. Our AI intelligently scores deviations based on product impact probability, helping your teams tackle critical issues first while efficiently handling routine cases with proven approaches.

Strategic Focus

Direct resources where they matter most. Our AI intelligently scores deviations based on product impact probability, helping your teams tackle critical issues first while efficiently handling routine cases with proven approaches.

Regulatory Inteligence

Strengthen regulatory compliance while minimizing risk exposure. Our AI identifies subtle relationships between seemingly unrelated deviations, helping you address systemic issues before they impact patient safety or trigger regulatory actions

Regulatory Inteligence

Strengthen regulatory compliance while minimizing risk exposure. Our AI identifies subtle relationships between seemingly unrelated deviations, helping you address systemic issues before they impact patient safety or trigger regulatory actions

Regulatory Inteligence

Strengthen regulatory compliance while minimizing risk exposure. Our AI identifies subtle relationships between seemingly unrelated deviations, helping you address systemic issues before they impact patient safety or trigger regulatory actions

  • Reduced Cycle Time

  • Identify Trends

  • Reduce Risk

  • Improve Margins

  • Redce Recurrence

Let Qwyn AI work for you.

Take the next step toward intelligen Deviation automation, and data-driven decisions.

Let's Chat

Privacy Policy

Terms

Qwyn AI © All Rights Reserved 2025

Let Qwyn AI work for you.

Take the next step toward intelligen Deviation automation, and data-driven decisions.

Let's Chat

Privacy Policy

Terms

Qwyn AI © All Rights Reserved 2025

Let Qwyn AI work for you.

Take the next step toward intelligen Deviation automation, and data-driven decisions.

Let's Chat

Privacy Policy

Terms

Qwyn AI © All Rights Reserved 2025