GxP compliance consulting for regulated processes, data and systems.

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.