Regulated quality that grows with digital change.
QFINITY is the management consultancy for risk-based quality management, GxP compliance and data integrity - from a single validation question to the digital transformation of entire quality organizations. We support pharmaceutical, medical technology and life science companies of every size, from start-ups to global corporations.
Quality is not a state, but a direction of travel.
We are committed to an integrated quality management approach - one that scales scope and detail to what is actually needed, keeps people part of the control architecture and stays focused on the right control objectives. We focus on identifying and evaluating process risks, then working with you to turn them into measures that are appropriate and effective.
Thought through across processes, delivered as one.
Years of experience across many client engagements have taught us not to treat GxP risks in isolation, but to weigh them together with the relevant business risks. The result is a risk matrix that shows process and business risks in a single picture - and aligns decisions with the overall risk.
Consulting
Strategy and implementation for compliance, quality and risk management - across the entire product life cycle.
Training
Training and workshops that genuinely build capability - from the fundamentals to specialist topics across the CSV/GxP world.
Audit
Strategy, planning and delivery of supplier assessments as well as postal, remote and on-site audits.
GxP project management
Planning and steering regulated IT and validation projects - risk-based, with a GAMP 5-based method set grown in projects since 2004.
An expert network, built around your needs.
Our network of experts reaches across Germany, and we select dedicated consultants to match your specific needs. Consulting, training and audit from a single source - a reliable roadmap through regulatory requirements.
We don't just apply the standards - we help create them.
That is rarely a sentence you can photograph - here it is. At the ISPE booth of the 2026 AI in Life Sciences Summit in Boston, Frank Henrichmann, Oliver Herrmann and Martin Heitmann are pointing at the GAMP guides on display - at their own work: Frank Henrichmann and Oliver Herrmann helped create the GAMP 5 Second Edition and co-led the Good Practice Guide for computerized GCP systems (2nd edition, 2024), and Martin Heitmann co-led the GAMP Guide: Artificial Intelligence. That network stands behind every engagement - assembled by experience and field of expertise, not an anonymous pool. The evidence is in our publications - see for yourself.
The expertise behind QFINITY.
Oliver Herrmann
Oliver Herrmann helps write the standards for regulated IT quality - he doesn't just apply them. Founder and CEO of QFINITY, he is an internationally recognized expert in quality management, computer and software validation, qualification, data integrity and the audit-ready use of artificial intelligence in the GxP environment. As GAMP Europe Chair, co-author of several ISPE GAMP guides and a contributor to program committees and digitalization & AI tracks, he drives the field forward - from classic computer system validation to the validation of AI-supported computerized systems. At QFINITY, he leads a team of top-tier specialists covering every GxP discipline - from GLP through GCP and GMP to GDP.
The full GxP scope, covered with confidence.
We work primarily with companies governed by European, American and Asian regulations. We cover the entire GxP range - from GLP, GCP and GMP to GDP, as well as medical devices and medical technology - with deep command of the resulting requirements for validating computerized systems and for the electronic records they hold.
One standard, many frameworks.
The same methodology carries across every relevant standard and regulation - only the level of detail adapts to the scope at hand.
- GLP, GCP, GMP, GDP and Medical Device GMP from a single source
- CSV of computerized systems across every domain
- Electronic records and signatures (ERES) put on a solid footing
Beyond compliance: the digital quality of tomorrow.
Regulatory obligation is the foundation - not the goal. We push quality further - to where it becomes a competitive advantage: in digital transformation, data governance and the responsible use of AI.
Digital Transformation
Digital transformation strategy, business process management and continuous improvement.
Data Governance & Integrity
Frameworks for data quality, data integrity and the handling of electronic records and signatures (ERES).
Validation & Qualification
Process validation, qualification of equipment and facilities, and validation of ERP and computerized systems.
AI & IT Infrastructure
Artificial intelligence in the GxP environment and IT infrastructure qualification - future-ready and built to hold up under regulatory scrutiny.
The people, references and expertise that make QFINITY.
Let's talk about your project →QFINITY supported us as a partner for CSV, CSA and AI in GxP throughout the development of Tenthpin Intelligent Certificate VerificAItion (T/ICV), our cloud-based, AI-driven certificate verification solution. Quality assurance and auditability were not treated as an afterthought but embedded in the agile development process from the outset: risk-based assurance, human in the loop as a design principle, quality oversight with clearly assigned responsibility. The result is a GxP-ready AI system with robust lifecycle evidence on which our customers can build their validation.
As a truly AI-native startup in the patient safety space, where there's no margin for error, we brought QFINITY in at the very start to help build our QMS from the ground up. Their guidance provided a framework that held up under scrutiny as we secured early adopters. We've since passed comprehensive client vendor audits, including leading CRO's, with zero major or critical findings, and are supporting client regulatory inspections. Quality is a competitive advantage, not a compliance tax.
QFINITY works with great passion and enthusiasm and has always been a valued contributor to the RQA DIGIT Committee's work during my time as chairman. I have worked directly with QFINITY, and they deliver above and beyond expectations time after time. I would have no problem at all recommending QFINITY as an inspirational, strategic partner.
I had the distinct pleasure of auditing one of QFINITY's clients. QFINITY worked with the client, first to understand their compliance position and then to work cooperatively with their leadership and workforce toward an advanced knowledge of regulatory requirements to create and improve processes and practices across the organization. I audited this technology provider before their collaboration with QFINITY and after, and the difference was remarkable and lasting. Excellent results.
QFINITY brings real passion and depth to GAMP and eClinical. A valued expert voice in the ISPE GAMP community - the ISPE GAMP Benelux Community of Practice had the opportunity to benefit from that expertise at our local GAMP CoP event.
QFINITY did a great job managing a sensitive process of quality control and approval for an emerging digital health company and a leading pharma sector customer. A pleasure to work with, and they understood how to drive business outcomes while ensuring quality and compliance.
Our IT Quality Management team engaged QFINITY to provide us a crash-course training on Computerized System Validation (CSV), and QFINITY delivered the course core content very clearly and answered our queries precisely.
I have been working with QFINITY for years and am very satisfied with the administration of project management, the flexibility, and, in particular, QFINITY's in-depth expertise in the GMP field. We look forward to continuing our collaboration with QFINITY.
Get your quality organization moving.
In a free intro call (about 30 minutes, by phone or online), we scope your needs - from a single validation question to the digital transformation of your QMS - and lay out the concrete next steps.
Book an intro call
