AI-powered Quality Oversight & Site Risk Management

Predict, manage, and mitigate site risk globally with AI-driven compliance.

Measurable Impact for Life Sciences Leaders

Predictive Risk Insights

Spot site compliance issues early and prevent costly disruptions.

65% Faster Qualification

Access 4,500+ ready-to-use audits with 450+ new reports monthly.

40% Lower Audit Costs

Switch to flexible, on-demand audits with our global network of expert auditors.

Audits that protect, Insights that prevent. AI-powered. Proactive. Outcome-driven.

Audit Platform

Streamline audit execution and manage compliance at scale with ease

Monitor upcoming audits, track progress, and quickly access reports, all in one intuitive platform.

Identify follow-ups, check renewal audit availability, and request new audits seamlessly.

Instantly access our extensive library of 4,500+ audit reports, reducing audit execution time by 65%.

Efficiently manage and close CAPAs with automated tracking, actionable alerts, and clear compliance dashboards.

Audit Platform

Quality Insights Platform

Predict and manage Site Risks Proactively with AI-Driven Insights.

Identify issues before they become critical, minimize disruptions, and maintain a resilient supply chain.

Select the best suppliers faster, avoid last-minute surprises, and secure reliable alternatives when needed.

Break down information silos with shared, standardized data, enabling faster decision-making and operational efficiency.

QIP

Tailored solutions built for your needs

Own supplier quality data

Digitize supplier site data, simplify compliance, and proactively manage risks.

Quality assurance

Track audits in real time

Streamline audits, monitor CAPAs, and access site quality risk assessments in ensure compliance visibility in real-time.

audit management

Qualify suppliers, fast​

Accelerate supplier selection, minimize sourcing risks, and secure trusted suppliers faster.

procurement professionals

Trusted by Industry Leaders

”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
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Check out our latest resources

Sync Space Session – Yin and Yang: Customized Quality Audits vs. Broad Coverage

Prof. Asena Serbezova explores how philosophical principles like Yin and Yang can guide the strategic alignment of customized audits with...

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Sync Space Session – Next generation Quality Oversight for Biomanufacturing

Dr. Juan Torres outlines how the future of quality in biomanufacturing depends on real-time supplier data, predictive analytics, and connected...

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Sync Space Session – AI in Compliance: Industry Innovations

Zuzana Horakova introduces the latest in digital compliance, including AI’s role in audit readiness, quality management, and real-time decision-making. See...

SyncSpace 2025 - 146

Ready to Digitize Audits and Transform 
Site Risk Management?