CONSULTING COMPANY FOR RISK-BASED QUALITY MANAGEMENT AND QUALITY ASSURANCE OF PROCESSES, DATA AND SYSTEMS

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WE SUPPORT PHARMACEUTICAL AND MEDICAL DEVICE COMPANIES IN ACHIEVING AND MAINTAINING GXP COMPLIANCE IN THE REGULATED DOMAIN.

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WE HELP WITH COMPUTERIZED SYSTEMS VALIDATION (CSV), COMPUTER SOFTWARE ASSURANCE (CSA), AND THE QUALIFICATION OF MODERN IT AND CLOUD INFRASTRUCTURES!

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We are a consulting company and support pharmaceutical and medical device companies in achieving and maintaining GxP compliance in the regulated domain.

We offer

ø15

Years of GxP experience of our consultants

80%

Employees active in GAMP/ACDM/ISACA

20+

Countries in which we support companies

130+

Customers in the GxP and supplier sector

20+

Speaker engagements per year

ARTIFICIAL INTELLIGENCE IN THE GXP-REGULATED ENVIRONMENT (AI/ML)

Artificial intelligence is the “next big thing” and is on a par with the invention of the steam engine, the automobile, the internet and the iPhone. The use of artificial intelligence will also fundamentally change the pharmaceutical industry in all areas, from research and development to the manufacture and distribution of medical products. AI systems are therefore also relevant to GxP and are subject to the same regulations.

MEET QFINITY

ISPE EU Annual Conference | 20.-22. April 2026

Meet QFINITY on site at the ISPE EU Annual Conference 2026 in Copenhagen and learn how digital compliance, AI, and GxP requirements can be brought together in a safe, future-proof, and practical way. Event: ISPE EU Annual Conference 2026 Location:…
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E-Learning Academy

The new QFINITY e-Learning Academy will go online this summer! It offers e-learning courses on various topics related to GXP and the validation of computerized systems.

From free short courses to get to know each other to modular e-learning courses with a certificate, there is something for everyone … and new content is constantly being added!

Current German-language courses:

GCP Basics for sponsors and sponsor service providers (modular GCP course with certificate)
GCP Basics: Risk-based quality management for sponsors and sponsor service providers
Current English-language courses:

GXP Micro-Training: funny animated short films on various GXP topics (free of charge)
Just take a look! Click here for the Academy

Q_FINITY CONTACT


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