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

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

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

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

Are your compliance and quality management processes up to date?
Tool-based validation (Jira, ADO etc.), CSA, Agile, CI/CD, XaaS-Cloud . We adapt your internal specifications within the regulatory framework so that you can benefit from current and upcoming innovations.
read more
What can and what must?
We support you in the implementation of regulatory requirements for the validation of computerized systems.
read more
Seeing through the GxP / CSV jungle?!
We offer training and workshops on general and specific topics in the CSV/GxP-regulated world.
read more
Do you have your suppliers under control or are you ready for an audit?
We support you in strategy, planning and execution of supplier assessments, postal audits and "on-site" audits.
read more

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

Our Costumer

Previous Next

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

MEET QFINITY^∞

Pharma 4.0 Conference with QFINITY | 9.-10. December 2025

Oliver Herrmann leads the Smart Validation Track at Pharma 4.0 Conference 2025. Our managing director Oliver Herrmann will be leading the track “Smart Validation (CSV) & QA for Smart Technologies: AI and Beyond” at this year’s ISPE Pharma 4.0 Conference.…

all dates

Q Page AI shutterstock_2544949177 [Konvertiert]

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.

OUR COMMITMENT

Previous Next

Q_FINITY CONTACT

Subscribe newsletter
I consent to my contact details and assignment being saved for possible queries. Note: You can revoke this consent at any time with effect for the future by sending an email to [email protected]. However, previous data processing remains valid. Details can be found in the data protection declaration.

*required