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Audit smarter, ensure global compliance, and catch risks earlier

Simplify supplier audits, track CAPAs effortlessly, and allocate resources more effectively with AI-powered insights.

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Qualifyze dashboard showing CAPA observations: 12 critical, 45 major, 80 minor, and 137 total, with donut charts for CAPA overall status, adequacy, plan response time, and closure time

How Qualifyze empowers your Audit Team

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

Instant access to ready-to-use audits

Access 5.000+ ready-to-use audit reports to cut execution time and let your auditors focus on high-risk, high-impact areas.

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
Audit Plan 2025 calendar view showing scheduled supplier audits across months, with a detail card for Sorlo Llorens inc showing audit date 19/11/2025 in Hartmell with action needed to provide billing info

Full audit oversight in real time

Get live oversight of internal and external audits with AI-powered tracking, all in one intuitive dashboard.

Audit Plan 2025 calendar view showing scheduled supplier audits across months, with a detail card for Sorlo Llorens inc showing audit date 19/11/2025 in Hartmell with action needed to provide billing info
Observations and remarks by audit table showing MediPharma Lab SLL with GMP APIs standard in Taizhou, listing 4 observations: 1 critical, 2 minor, and 1 remark, all referencing ISO 15378 clauses

CAPAs under control, always on time

Track CAPAs automatically and get instant flags on overdue actions, without chasing suppliers.

Observations and remarks by audit table showing MediPharma Lab SLL with GMP APIs standard in Taizhou, listing 4 observations: 1 critical, 2 minor, and 1 remark, all referencing ISO 15378 clauses
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

Proactive risk detection, not just reporting

Identify and prioritize risks early with AI-driven insights, so you can act before issues escalate.

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
Members management panel showing four team members: Victoria Soto, Manuel Lombardo (Admin), Alexandra Casas (Member), and Ricardo Soles (Admin), with options to invite, remove, or edit members

Built for collaboration, without limits

Enable seamless teamwork across Quality, Audit, and Procurement teams with unrestricted user access, no seat limits, no silos.

Members management panel showing four team members: Victoria Soto, Manuel Lombardo (Admin), Alexandra Casas (Member), and Ricardo Soles (Admin), with options to invite, remove, or edit members

Proven outcomes for
Audit management teams

40% reduction in audit costs

65% faster audit execution with ready-to-use audit reports

95% accuracy of risk predictions with AI

Explore the tools driving Proactive Compliance and Site 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.

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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.

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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

Simplify audits and gain proactive compliance visibility

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