Classic eQMS
Document at the centre, process "grafted on" via a workflow.
agentiQMS
Process at the centre. Documents emerge as outputs.
17 specialized AI agents run your quality processes themselves — from intake to PSUR. Human-in-the-loop by design.
I'll walk you through the website in about 3 minutes.
Classic eQMS are document managers with a workflow on top. We start where quality actually happens — in the process. Six things change:
Document at the centre, process "grafted on" via a workflow.
Process at the centre. Documents emerge as outputs.
Staff must know which form, when. Steep onboarding.
The agent knows the context and guides. HITL by design.
AI as an isolated feature: "smart search", "auto-tagging".
AI throughout: classification, root cause, signal detection.
Audit as a document review after the fact.
Continuous audit — native to the agentiQMS Core, in real time.
Risk as a static Excel FMEA, updated manually.
Live risk model updates on every NC, complaint, PSUR.
Validation as a one-off project at go-live.
Continuous validation — native to the Core, evidenced daily.
The agentiQMS Core is always its own platform — you simply decide where your data lives. In Layer Mode your existing systems stay in charge and agents connect them. In Platform Mode everything runs natively in the Core. Both are permanent paths — switching is possible, but never required.
An event-driven architecture: the agentiQMS Core at the centre, the Shared Event Bus as its communication channel, 17 agent modules attached — fed from your systems. Here, AI isn’t bolted on — it’s the system’s DNA. That’s agentiQMS.
Before we automate a single process, we build the foundation: agentiQMS Core connects your systems (ERP, CRM, DMS …), understands your QMS as a connected whole, and surfaces where logic and compliance have gaps. It ships as a Core package — and delivers massive value on its own.
The Core alone monitors compliance continuously, validates itself, keeps the tamper-evident audit trail and keeps the document register alive — without a single specialist agent running. The 17 specialist agents build on top and take over the processes.
Every module takes administrative, documentation and follow-up work off your team — so your experts can focus on the real quality work, while the agentiQMS Core keeps the entire audit landscape continuously visible.
Indicative estimates — the exact leverage varies by company size, product portfolio, CAPA volume and module selection.
Less firefighting, less paperwork. Teams focus on judgement, not data entry.
Your most experienced people stop being clerks — they make quality decisions.
CAPAs close faster — quality turns from bottleneck into driver.
Real AI capability in the quality organisation — before competitors get there.
Visible quality costs are only the tip of the iceberg. The DeFeo/Juran framework quantifies the true cost of poor quality.
agentiQMS is not just validatable — the agentiQMS Core continuously validates itself. An architecturally independent watchdog inside the Core monitors the platform continuously.
Inline check of every agent output before it reaches the user or downstream systems.
Periodic, independent regression runs against QA-approved reference datasets. Signed ALCOA+ audit trail.
Responds to relevant changes with proportionate revalidation depth — up to full requalification.
Hosting in your region (EU or US), regional residency, encryption in transit & at rest, five-year tamper-evident retention — all under external audit procedures.
Established ISMS for change management, access control, encryption, audit logging.
Annual audit on security, availability, confidentiality.
DPA, processing register, DPIA-ready, subprocessor list.
By HITL-by-design and excluding autonomous clinical decisions.
Your data is never used to train AI models. Regional hosting of your choice — EU or US (AWS), AES-256 at rest, TLS 1.3 in transit, 5-year ALCOA+ retention.
Full support from pilot to live operation. A team that knows your industry, your processes and the regulatory expectations.
Full support from phase 0 to go-live. IQ/OQ/PQ together with your validation team.
Structured onboarding for QA, RA and operations teams.
Ongoing support, module updates, regulatory adaptations. No sales pressure.
Your ideas feed into platform development. Additional modules possible.
Direct answers to the questions QA, RA and operations teams ask most often — from the architectural difference to compliance, data residency and deployment.
agentiQMS is an AI-native, process-first electronic Quality Management System (eQMS) for MedTech. It is built on an event-driven architecture with a central agentiQMS Core and 17 specialized AI agents that operate quality processes end-to-end — from intake to PSUR — with continuous validation and human-in-the-loop oversight. Unlike a classic eQMS, the process is at the center and documents emerge as outputs. agentiQMS can be deployed as a layer on top of your existing systems (eQMS, ERP, MES, SharePoint …) — no system needs to be replaced.
A classic eQMS is document-centric: the document sits at the center and the process is grafted on via workflow. agentiQMS is process-first — each of the 17 agents owns its process, knows the context and guides staff through it, while documents emerge as outputs. AI is not an isolated add-on feature but runs throughout (classification, root cause, signal detection). Auditing and validation run continuously and in real time rather than as after-the-fact projects, and the risk model updates live with every NC, complaint or PSUR. And while a new eQMS usually means rip-and-replace, agentiQMS can run in Layer Mode on top of your existing systems — no system needs to be replaced.
The agentiQMS Core is the central event-driven platform with a Shared Event Bus that connects your systems in real time. It delivers value from day one — continuous compliance, self-validation, audit trail, e-signatures and a living document register — before any agent runs. Connected to it are 17 specialized AI agents (Intake, Risk Intelligence, Change Control, Complaint, NC, CAPA, PSUR, Regulatory Affairs, Management Review and more) that run quality processes themselves — always with a human in the loop.
Yes — both. agentiQMS models the QMS value chain along ISO 13485 (the standard the FDA QMSR now incorporates), and it meets 21 CFR Part 11 with qualified e-signatures, review queues on Hard-HITL approvals and a complete, tamper-evident audit trail from day one. The platform also addresses GAMP 5, IEC 62304, IQ/OQ/PQ, ISO 14971, ALCOA+ and the EU AI Act — with continuously demonstrated validation rather than one-off commissioning projects.
Hosting is in the region of your choice — EU or US (AWS) — with regional data residency: your data stays in the chosen region. Data is encrypted with AES-256 at rest and TLS 1.3 in transit, and retained tamper-evidently for five years under ALCOA+. Your data is never used to train AI models. Operations run under external audit procedures, and through HITL-by-design and the exclusion of autonomous clinical decisions the system sits outside Annex III of the EU AI Act.
There are two permanent deployment paths. In Layer Mode your existing systems (eQMS, ERP, MES, PLM, SharePoint) stay the system of record; the agents connect them through the event-driven Core and write results back — no rip-and-replace, low barrier to entry. In Platform Mode everything runs natively in the Core on a single data layer, with no connectors or synchronization, delivering the highest performance and end-to-end Continuous Validation. You can migrate module by module, but you don't have to.
agentiQMS is human-in-the-loop by design — people decide, while agents pre-fill and escalate intelligently. Every agent output is first checked inline and, based on its confidence, routed into one of four bands: Auto-Approve (high), Soft-HITL with one-click release (medium-high), Hard-HITL with a review queue and qualified Part 11 e-signature (medium-low), or Block + Alert with an auto-incident and CAPA trigger (low). Autonomous clinical decisions are excluded by design.
Thirty minutes are enough to see what an AI-native QMS changes for your team. Tell us briefly what it’s about — we’ll get back to you as soon as possible with a proposal for a call or a live demo. No strings attached, no sales-pipeline pressure.
Executive Partner — MedTech & Strategic Accounts
1. We get back to you as soon as possible.
2. Short discovery call (30 min).
3. Tailored demo or pilot proposal.
Under NDA on request — and with data residency of your choice: your data stays in your region, EU or US.