QFINITY references - QFINITY
QFINITY · Our Company · References

Successful collaboration that speaks for itself.

References are not a showcase - they are proof that our methodology delivers in practice. From global corporations to specialist biotech firms, we resolve complex GxP questions and produce results that stand up to inspection.

References & Ratings

Trust is earned through results you can prove.

Rather than saying it ourselves, we let our clients speak: the voices below are quoted verbatim from projects, audits and industry committee work - from one-off projects to partnerships spanning many years.

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.

TW
Thomas Weber
Chief Product Officer - Tenthpin Solutions, Switzerland

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.

AM
Andrew Mitchell
AI for Pharmacovigilance / Patient Safety - YEZA.AI, USA

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.

MJ
Matt Jones
CEO - Digital Quality Associates, UK · Chair of the Board - Research Quality Association (RQA)

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.

JG
Jennifer Giles
IT Quality Assurance Professional - former Parexel, USA

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.

TD
Tom De Rudder
Former Chairman - ISPE GAMP Benelux CoP, Belgium

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.

MP
Morris Panner
Digital Health & Cloud Imaging Executive - USA

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.

WA
Wan Azman
Director Global IT GRC - B. Braun Group, Malaysia

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.

MS
Markus C. Schmidbauer
Founder - AiMS ISO & AiMS Safety, Germany
Two ways into our work

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Client range · breadth, not a showcase

From global corporations to niche specialists.

This range shows a method that scales - from the dossier volume of a global pharma group to a single validation question at a niche biotech. The sequence remains the same; only the level of detail adapts.

Global corporationsPharma, medtech, bioprocessing, industry
Mid-sized companiesEstablished manufacturers, CROs, software, industrial plant
Specialists & researchBioanalytics, CROs, diagnostics, phytomedicine, academia

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