Login
Schedule a Demo

From Compliance Gaps
to AI-Powered Quality Managementt

Centralize quality data, predict risks early, and stay ahead of compliance issues, before they escalate.

Watch 3-Minute Demo
Qualifyze Site Analytics dashboard showing 341 total sites with an overall risk score of 70.5 (Good), 68 sites with poor scoring (20%), 121 sites with open CAPAs (35%), 148 with medium scoring (54%), and 2 with warning letters. Quality Assistant panel highlights alerts including warning letters for Chio Pharma and Terrassa IND, 5 sites with critical observations, 50 with major observations, and updated FDA Nitrosamines and EU GDP guidelines

How Qualifyze solves your challenges

Quality Assistant panel showing alerts: Chio Pharma received a Warning Letter on 22 Nov 2024, Terrassa IND received a Warning Letter on 15 Jan 2025, 5 sites with unresolved critical observations, 50 sites with unresolved major observations, and FDA revised Nitrosamines guidance

Unified Quality Data Hub

Leverage Qualifyze AI capabilities to unify audit reports, supplier data, and regulatory insights, streamlining workflows and ensuring greater accuracy.

Quality Assistant panel showing alerts: Chio Pharma received a Warning Letter on 22 Nov 2024, Terrassa IND received a Warning Letter on 15 Jan 2025, 5 sites with unresolved critical observations, 50 sites with unresolved major observations, and FDA revised Nitrosamines guidance
Risk score of sites scatter chart plotting supplier risk scores against last audit date, with colour coding for Excellent, Good, Acceptable and Poor ratings. Chio Pharmaceuticals is highlighted with a Poor score of 40

Efficient and effective Quality Risk Management

Smart resource allocation powered by AI. Prioritize risks and equip auditors with global market insights for stronger preparation.

Risk score of sites scatter chart plotting supplier risk scores against last audit date, with colour coding for Excellent, Good, Acceptable and Poor ratings. Chio Pharmaceuticals is highlighted with a Poor score of 40
Site risk score histogram showing scoring distribution with a bell curve, highlighting Chio Pharmaceuticals with a Poor score of 40, positioned in the lower end of the distribution

Proactive Quality Risk Identification

Spot potential supplier compliance issues before they escalate, using predictive analytics to stay ahead of risks and maintain uninterrupted operations.

Site risk score histogram showing scoring distribution with a bell curve, highlighting Chio Pharmaceuticals with a Poor score of 40, positioned in the lower end of the distribution
Audits Library dashboard showing 3,100 total audits (2,925 existing, 165 planned), listing suppliers such as Hunan Judian, Dullberg Konzentrat, and Dupont Nutrition with their audit standards, countries, and scheduled dates

Accelerate Supplier Compliance

Gain instant access to over 5.000 audit reports, speeding up supplier qualification by 65%, saving valuable internal time and resources.

Audits Library dashboard showing 3,100 total audits (2,925 existing, 165 planned), listing suppliers such as Hunan Judian, Dullberg Konzentrat, and Dupont Nutrition with their audit standards, countries, and scheduled dates
CAPA Overall status donut chart showing 75% open and 25% closed, alongside CAPA Closure time chart showing 40% closed in 0–2 months, 25% in 3–12 months, 30% in 2–6 months, and 5% over 12 months

Simplified CAPA Management

Digitally manage CAPAs while AI benchmarks supplier performance, ensuring timely closures and driving continuous quality improvement.

CAPA Overall status donut chart showing 75% open and 25% closed, alongside CAPA Closure time chart showing 40% closed in 0–2 months, 25% in 3–12 months, 30% in 2–6 months, and 5% over 12 months

Proven outcomes for Quality teams

Shift from reactive to proactive supplier risk management

Real-time view of your supplier performance

Benchmark your supplier compliance

Explore the tools driving Proactive Compliance and Supplier Risk Management

Audit Management Platform

Centralize and simplify global audit management. Plan, execute and track audits with AI, so your team can focus on what really matters.

Learn more

Quality Insights Platform

Turn disconnected compliance data into AI-powered insights. Monitor supplier performance in real time, detect risks early, and drive smarter, faster decisions.

Learn more

What they say about us?

”It’s the closest to having an extra member in our team. From alerts to CAPA follow-ups to structured reports, Qualifyze gives us everything we need while making the most out of our resources.”

Àngels Llarch, Head of Quality Assurance, Qualified Person and Pharmacovigilance
Head of Quality Assurance, Qualified Person and Pharmacovigilance - Noucor

“We chose to collaborate with Qualifyze, not only for their extensive audit database and fast delivery times but also for the precision and high quality of their reports.”

Anna Prats Huguet
Quality Assurance Technician at Qualix Pharma

“Aenova is aware of this responsibility and therefore prefers to work with excellent partners, such as Qualifyze”

Dr. Irayani Berger
VP Corporate Quality at Aenova Group

“Qualifyze helped us reduce costs and time thanks to their team of experienced auditors.”

Ramona Seemann, Quality Management
Advance Pharma GmbH, part of Aristo Pharma – Customer

“When Qualifyze audited us in 2021, we were impressed by the auditor’s qualification, precision, and profound knowledge. The audit also helped us a lot since it was comparable to an authority audit.”

Dirk Berrisch, Deputy Head of Quality Assurance
Caesar & Loretz (Caelo) – Auditee

“We have valued our experience working with Qualifyze on audit reports because of their reliable customer service, collaboration and thoroughness.”

Jurate Singh
Global Quality Audit Planner and Systems Lead – Teva

“We chose Qualifyze because of their reliable customer service and the good quality of the audit reports at a fair price. Our requests were handled with flexibility and willingness to compromise.”

Dr. Ralf Grulke, Head of Quality Unit
Dr. Pfleger – Customer

Digitize your quality processes and proactively reduce compliance risk

Watch 3-Minute Demo