The only AI that investigates your entire deviation with you
From intake to closure—Qwyn helps you solve it, not just document it.
Built for industry by experts who've done the work
Enterprise builders
Building and scaling enterprise software—led by outcomes and strategy.
Domain veterans
Combined manufacturing and quality expertise across the team.
THE STAKES
Drug shortages make headlines. Deviations cause them.
dollars in pharma manufacturing is lost to poor quality—deviations, investigations, recalls
burned every year fixing problems that started as a single unresolved deviation
active drug shortages in 2026—and the number is still climbing
Mounting investigation backlog
01Every deviation gets the same slow, manual process. Investigations pile up and batch releases slip.
Investigation quality crisis
"Human error" becomes the catch-all root cause—masking the real manufacturing, equipment, and process failures.
Increased recurrence rates
Shallow non-systemic root causes lead to ineffective CAPAs letting the same failures recur and escalate—straining teams already underwater.
Mounting investigation backlog
Every deviation gets the same slow, manual process. Investigations pile up and batch releases slip.
Investigation quality crisis
"Human error" becomes the catch-all root cause—masking the real manufacturing, equipment, and process failures.
Increased recurrence rates
Shallow non-systemic root causes lead to ineffective CAPAs letting the same failures recur and escalate—straining teams already underwater.
Speed and rigor have always pulled in opposite directions. Qwyn brings them together—quality and depth, side by side. So deviations get solved, not just documented—and patients get their medicine faster.
QWYN AI PLATFORM
One platform for the entire GMP lifecycle
Agentic investigations, historical trend analysis, predictive quality, and regulatory intelligence—purpose-built for GMP on one auditable agentic platform.
Qwyn SimRA
Similarity & Risk Analytics
Search historical deviations and trends to find precedent, patterns, and recurring risk.
Qwyn Predict
Predictive analytics for manufacturing quality trends
Qwyn Regulatory
Regulatory intelligence and compliance monitoring
One system of intelligence. One audit trail. Built for GxP.
Investigations aren't a conversation. They're an engineered process.
Chat tools give a different answer every time. GMP demands standardized, defensible outcomes—so Qwyn reimagines the entire investigation workflow as an engineered agentic system, not a prompt box.
Chatbots & copilots
- Freeform prompts—a different answer every time
- Outcomes depend on who's asking
- No standardization across sites or shifts
- Hard to validate, audit, or defend
Qwyn: engineered workflow
- Reimagined investigation workflow—not a prompt box
- Standardized structure on every case
- Repeatable process across sites and shifts
- Systemic root cause, audit-ready by design
Top Hypothesis
Environmental monitoring protocol gap—HVAC filter maintenance schedule misaligned with production cycles
Confidence
94%
Same engineered workflow, every investigation—standardized, structured, audit-ready.
CAPABILITIES
The intelligence layer for GMP investigations
From disparate data to defensible root cause, Qwyn Investigate unifies, reasons, and proves across the entire investigation lifecycle.
Unify
Connect & standardize
Unify every signal
Batch records, LIMS, deviations, SOPs, and documents, unified into one picture.
Standardize every investigation
One defensible workflow across every site, team, and shift.
Configured to your quality system
Adapts to your SOPs, deviation types, and frameworks.
Reason
Investigate at depth
Evidence-based hypotheses
A full hypothesis set grounded in your data, not the easy answer.
Industry-leading RCA frameworks
5 Whys, causal chains, and 6M, run at machine speed.
Systemic root cause, not human error
Pushes past 'operator error' to the gaps that drive recurrence.
Prove
Trust & scale
Auditable, human-in-the-loop AI
Every decision and citation traceable, with your experts in control.
Audit-ready reports, automatically
GMP-aligned reports with full evidence trails, in minutes.
Analysis on any data
Interviews, batch records, or raw data, turned into review-ready analysis.
HOW IT WORKS
From deviation alert to closed CAPA
Here's how Qwyn works alongside your team—at every stage.
Deviation Logged
Your system captures a deviation. Qwyn instantly ingests event data, batch records, and historical context.
Hypotheses Generated
Qwyn applies industry-standard frameworks—starting with 6M—to generate a comprehensive hypothesis set. Not just the obvious answer.
Investigation Plan Built
A risk-ranked plan delivered to your team, prioritizing highest-probability root causes.
Root Cause Identified
Analyzes incoming evidence against its hypothesis tree, narrowing to true root cause with full justification.
HVAC filter maintenance schedule misaligned with production cycles. Filter replacement intervals exceeded manufacturer specifications during peak production periods.
CAPA & Report
Compliant, audit-ready investigation report with targeted CAPA recommendations to prevent recurrence.
Implement condition-based HVAC filter maintenance aligned with production scheduling system.
Outcomes
Measurable impact across your operations
Qwyn delivers depth and speed—so investigations close faster, root causes drive to systemic gaps, and repeat deviations decrease.
Cycle Time Reduction
Reduce investigation cycle time from intake to closure—without adding headcount.
Human Factor Root Cause Reduction
Move beyond the default 'operator error' to systemic level root cause.
Recurrence Reduction
CAPAs that address true root causes—fewer repeat deviations on the same failure mode.
Results reflect trending improvements observed across Qwyn customer deployments. Individual outcomes may vary and are not guaranteed.
What leading manufacturing and quality teams say
Trusted by investigators who refuse to settle for surface-level answers
Since implementing Qwyn Investigate, we’ve seen a measurable reduction in human error as a root cause category. We’re finally fixing the right things.
DDirector of QualityGlobal CDMOThe CAPAs we generate now are tied directly to verified root causes. Our recurrence rate has dropped because we’re not guessing anymore.
VVP of Quality AssuranceGlobal PharmaQwyn Investigate gave us a consistent, repeatable investigation process across our team — something we struggled to achieve before.
QQuality Systems ManagerGlobal CDMOWe were live on day one. No months-long implementation, no consultants — just the tool working.
HHead of Manufacturing OperationsGlobal PharmaThe Qwyn team responds faster than any vendor we’ve worked with. They feel like an extension of our quality team.
SSenior QA ManagerGlobal CDMO
TRUST & COMPLIANCE
Where AI transformation meets enterprise-grade control
Your quality data stays protected while meeting the regulatory standards your auditors expect.
Security and Compliance
Aligned to industry-leading standards including ISO 27001, with enterprise-grade features like complete audit trails and human-in-the-loop oversight on every decision.
No Training on Customer Data
Your data is never used to train models. Zero data retention policy with LLMs. You retain complete control over your data.
Flexible Deployment Options
Built on industry-standard multitenant SaaS architecture. Single-tenant deployments available for organizations requiring a dedicated, isolated environment.
Risk-Based CSA Validation
The Qwyn team works with you to complete CSA risk-based validation, ensuring your deployment meets GxP computerized system assurance requirements.
INTEGRATIONS
Integration-ready for your environment
Qwyn AI connects to your quality ecosystem through secure, purpose-built integrations tailored to your environment.
Quality Management (QMS)
Veeva Vault Quality, TrackWise, MasterControl, and others
Laboratory (LIMS)
LabWare, STARLIMS, Benchling, and others
Enterprise Resource Planning (ERP)
SAP QM, Oracle, and others
Environmental Monitoring (EMS)
Vaisala, Particle Measuring Systems, and others
Every integration is tailored for your environment in weeks not months.
Our team works with yours to design, build, and validate secure integrations that meet your specific workflows, data requirements, and compliance standards.
Assess
Map your systems
Build
Secure connectors
Validate
GxP-compliant
BUILT FOR YOU
Built for the people who own pharmaceutical quality
VP / Head of Quality
Investigate deeper without scaling headcount. AI-powered depth across every deviation, turning quality from cost center to competitive advantage.
Quality Investigators
Focus on what needs your expertise. Qwyn handles hypotheses, plans, and reports so you focus on complex cases.
Operations & Manufacturing
Fewer repeat deviations, less downtime. Accelerates resolution and identifies systemic issues before line impact.
Compliance & Regulatory
Stronger posture before the inspector arrives. Audit-ready documentation and true root cause analysis.
BACKED BY
Backed by investors who believe in the future of quality
Supported by leading investors in pharmaceutical innovation and enterprise AI.
Coming soon
Frequently Asked Questions
We're compiling answers to the questions teams ask most. Check back soon.
Your next deviation is already waiting. Qwyn should be too.
See how AI-powered deviation investigation reduces your backlog, accelerates root cause analysis, and delivers CAPAs that actually prevent recurrence.