QFINITY GxP Compliance: Consulting for Regulated Processes, Data and Systems.
QFINITY GxP compliance encompasses consulting, implementation, training and audits for pharma, MedTech and their service providers. We build control architectures for quality processes, data, computerized systems and AI applications, from paper-based workflows to agile, cloud-based ways of working. The evidence for regulators and client audits is produced as part of the project work.
Four tasks that are decisive for GxP compliance.
We present three of them here. How we approach AI follows in the next section. In the intro call, we clarify which task is on your desk.
QMS, processes and quality culture
We build quality management systems whose processes reflect how the work is actually done, and we train the teams that operate these systems. Along the way, the teams embed Critical Thinking in how they work.
Explore the QMS services →Data Governance, Quality and Integrity
Compliance follows the data, from collection to archiving and across system boundaries. We apply ALCOA++ to the data flows of your processes and check at every system handover whether the evidence trail remains traceable.
Explore Data Integrity →Validation and CSA
The scope of testing follows the risk, not habit. What gets tested is decided by your subject matter experts using Critical Thinking. The rationale for that decision is part of the evidence, not a substitute for it. We embed validation in your tools and release cycles, for classic systems and SaaS alike.
Explore validation →All four tasks sit within the digital transformation in the GxP environment. We also offer training and workshops as well as supplier audits, delivered by post, on site or remotely.
Artificial intelligence in the GxP environment: positioned, governed, demonstrated.
Explore our AI overview →Contributors to the standards you apply.
QFINITY consultants served on the core team of GAMP 5 2nd Edition and contributed to the GAMP Good Practice Guide Enabling Innovation. We know the methodology behind our validation work from the inside.
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.
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.
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.
QFINITY publishes in the ISPE trade press.
What we publish on artificial intelligence in regulated environments and present at the leading conferences comes out of real projects.
How AI Will Transform Computerized System Validation
The article sets out what AI-supported validation depends on: documented processes, precise requirements and structured risk assessments. AI-enabled tools can shorten validation cycles and raise test coverage. Accountability stays with people.
Read the article at ISPE Pharmaceutical Engineering↗Human-in-the-Loop as an Illusion of Control?
Human-in-the-Loop alone does not establish control. The article describes the conditions under which Human Oversight becomes effective. That requires the reviewer to understand the model's operating context and limits, and to have the authority to object.
Read the article→Go deeper and build capability.
Where you can meet us next
Start with a readiness assessment.
The European Commission has published drafts of a new Chapter 4, a revised Annex 11 and the new Annex 22 on AI. The version of Annex 11 in force today was published in January 2011 and took effect on 30 June 2011. The lead time back then was no more than half a year. In three to six weeks, the readiness assessment shows where your data, systems and AI applications stand against these drafts.
What might the start of our collaboration look like?
In a free intro call (about 30 minutes), we work out together whether your starting point is your QMS, validation, CSA, Data Integrity, AI Governance or audits, and define the next concrete step. You talk directly with experienced GxP consultants, not with sales.
Book an intro call
