Regulated quality that grows with digital change.
QFINITY is the management consultancy for risk-based quality management, GxP compliance and data integrity. Our engagements range from a single validation question to the digital transformation of entire quality organizations. We work with pharmaceutical, medical technology and life science companies, from start-ups to global corporations.
Quality is not a state, but a direction of travel.
We stand for quality management that runs end to end and scales to what is actually needed. It builds people into the control architecture and aims every control at the purpose it is meant to serve. Our focus: spotting risks in your processes and turning them into effective measures with you.
Thought through across processes, delivered as one.
Working with 200 clients has taught us to look at GxP risks alongside the relevant business risks. The result is a risk matrix that shows GxP and business risks in a single view. We align decisions with that overall risk.
Consulting
Strategy and implementation for compliance, quality and risk management across the entire product life cycle.
Training
Training and workshops that prepare teams for day-to-day practice. Topics range from the fundamentals to specialist questions in CSV and GxP.
GxP project management
Risk-based planning and delivery of regulated IT and validation projects with a GAMP 5-based set of methods built up across our projects since 2004.
An expert network, built around your needs.
Our network reaches across Germany and works internationally. For each engagement we assemble the consultants whose experience fits the need. That gives you consulting, training and audit from a single source, plus support in meeting the regulatory requirements of your project.
We don't just apply the standards of our industry - we help create them.
Evidence for a claim like that can rarely be photographed. This time it can: the photo shows Frank Henrichmann, Oliver Herrmann and Martin Heitmann at the ISPE booth at the 2026 AI in Life Sciences Summit in Boston, pointing at the GAMP guides on display, and with them at their own work. Frank Henrichmann and Oliver Herrmann contributed to the GAMP 5 Second Edition and co-led the Good Practice Guide for computerized GCP systems (2nd edition, 2024); Martin Heitmann co-led the GAMP Guide: Artificial Intelligence. The evidence is in our publications. See for yourself.
The expertise behind QFINITY.
Oliver Herrmann
Oliver Herrmann helps shape the standards for regulated IT quality. Founder and CEO of QFINITY, he is an expert in quality management, the validation of computerized systems, qualification, data integrity and the use of artificial intelligence in the GxP environment in a form that holds up with regulators. As GAMP Europe Chair, co-author of several ISPE GAMP guides and a contributor to program committees and conference tracks, he drives the field forward. His topics range from classic CSV to AI-supported computerized systems. At QFINITY he leads a team of specialists covering all GxP disciplines from GLP to GDP.
Who we work for.
We work for pharmaceutical, biotech and medical technology companies as well as pharmaceutical contract manufacturers (CMO/CDMO). Our clients also include software and service providers that supply these companies. Their products and processes are governed by European, American or Asian regulations. We cover the entire GxP range including medical devices. We know the requirements for validating computerized systems and for the electronic records held in those systems, and we implement them.
Who comes to us, and with what question.
One methodology, many frameworks.
The same methodology applies to each of the frameworks listed below. The level of detail follows the scope at hand.
- GLP, GCP, GMP, GDP and Medical Device GMP from a single source
- CSV across all GxP domains
- Electronic records and signatures (ERES) under Part 11 and Annex 11
Beyond compliance: the digital quality of tomorrow.
Regulatory obligation is the foundation. We take quality further, to where it becomes a competitive advantage: in digital transformation, data governance and the responsible use of AI.
Quality Management and Processes
Quality management systems, quality assurance processes and process management that work day to day and stand up in an inspection.
Digital Transformation
Digital transformation strategy, business process management and continuous improvement.
Data Governance and Data Integrity
Approaches to data quality, data integrity and the handling of electronic records and signatures (ERES).
Validation & Qualification
Process validation, qualification of equipment and facilities as well as validation of ERP and other computerized systems.
AI & IT Infrastructure
Artificial intelligence in the GxP environment and qualification of the IT infrastructure, both backed by evidence that holds up in inspection.
The people, references and expertise that make QFINITY what it is.
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 project and lay out the concrete next steps, whether that is a single system question or the redesign of your entire QMS.
Book an intro call
