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Qualifyze Audit Reports benefits

5.000+ audits and counting

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Get instant access to our unmatched GxP audit database, featuring over 5.000 audits and counting

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150+ new audits conducted every month

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Improve efficiency and expedite your audit process. From request to delivery, a new audit can take months to finalize. Our audit library lets you spend less time chasing audit dates and dealing with urgent audit requests, and more time to focus on other tasks.

Explore all the audits
Qualifyze is specialized in:

Bespoke audits

Internal audits | Mock inspections | Gap analysis

Upon agreement

Cosmetics

ISO 22716

Packaging materials

Primary and Seconday

ISO 15378 | ISO 9001
Applicable parts of the EU GMP Part 1 when necessary

Other vendors

ISO 9001

Excipients

IPEC, PQG Joint GMP Guide for Pharmaceutical Excipients

Food

IFS/BRC | FSSC/ISO

API (Active Pharmaceutical Ingredients) / Drug substances

ICH Q7, EU GMP Part II

Clinical Trials

Investigational sites | Vendors/Suppliers | Laboratories

ICH GCP and applicable GxP guidances when necessary

ESG

GRI Sustainability Reporting Standards

Software vendors

GAMP 5

Medical Devices

EU MDR (GMP) | ISO 13485

FDF (Finished Dosage Forms) / Drug products

EU GMP Part I (Including its Annexes when necessary)

Transport and/or Distribution (raw materials and FDF)

EU GDP (2015/C/95/01) and/or EU GDP (2013/C/343/01)

Pharmacovigilance

Services | Vendors

EMA GVP and applicable GxP guidances when necessary

Subcontracted Laboratories

Physicochemical testing | Microbiological testing | Bioanalytical testing | Stabilities | …

Applicable GxP guidances

We’ve helped more than 1500 companies stay compliant

Trusted by our clients

”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