Automate Your Compliance with Deterministic AI Agents.
One framework for every team accountable for compliance, built on the knowledge you already have.
Put specialised AI agents to work inside your QMS
One framework for every team accountable for compliance
Change Management
01 / 08Build a change management agent from your existing SOP, running under your governance with the right human in the loop.
The framework
From your SOPs to auditable agents - build, deploy, and monitor in one place
Caryon turns your procedures into agentic workflows that execute the process, enforce the rules, and produce the evidence as they run, always under your control.
From SOP to executable workflow
Start from an empty canvas, a certified library template, or let the Caryon AI generate the workflow from your procedures and documents. Each block is bound to the requirement it satisfies, so the process is compliant by construction.
Deterministic by design
Your SOPs, records and controls stay the source of truth. The agents do the work around them.
Built on top of your existing knowledge
Existing procedures, templates and technical documentation become the ground the agents reason on.
Fits your organisation
No migration. The software adapts to your processes and tools, so your organisation never has to adapt to the software.
Deterministic and sovereign
Same input, same output. Every answer traced to its source. Runs in your infrastructure - your data never leaves it.
Stays compliant
When regulations and standards such as ISO 13485 evolve, a full gap analysis shows what needs updating.
Specialised and frugalLess compute, less energy
Our models are specialised and frugal. They run next to your confidential data. A small model trained for one task consumes a fraction of what a general-purpose one does. Less compute, less energy, cheaper to run and easier to host.
You're in the right place if
- you maintain several device families across multiple jurisdictions
- your QMS, PLM and documentation live in separate systems
- regulatory updates land faster than you can adapt your QMS and TDs
- impact analysis depends on a few people who know how everything connects
- your confidential data can't leave your infrastructure
- you don't trust an LLM to write your technical file - and you're right not to
Our model
A compliance engine at the core. A solution shaped around your use case - running on your existing knowledge, from day one.
We start from your problem
A working session with your QARA and teams to pin down one recurring pain, in your words.
We build it on top of our framework
Your data, your documentation, your procedures, your standards, structured by our compliance framework. No complex migration to handle.
Your teams take it over
We onboard the people who will use it day to day, then measure against a T0 we freeze before starting - so the gain is a number you set, not a claim we make.
You get the result, not just the tool.
Discuss your use caseThe compounding effect
Where the value shows up over time.
Your knowledge stops living in people's heads
What one person wrote becomes usable by everyone. Finding what applies no longer depends on knowing who to ask.
Quality stops being a relay race
R&D, operations and clinical teams can act inside quality processes, with guidance. Reviews run in parallel instead of queuing at QA/RA.
Agents built with ethics & control
Agents propose and execute; people approve. No step is bypassed, and every decision traces back to its source.
Our technology
A digital twin of your compliance system. A proof engine on top of it.
Caryon builds a complete ontology of your QMS and your technical documentation: every artefact, every requirement, every link between them. On top of it, a neuro-symbolic engine combines high-level reasoning with formal mathematical validation - so every output is checked against the constraints and policies, not just generated. The engine sits on top of the stack you already run.
From ingestion to a complete ontology
Collect
Curate
Analyze
Evaluate
Categorize
Ontology
Ontology
Sovereign by architecture
Confidential design data stays inside your infrastructure.
Your premises. Our GPUs.
On-premises
A Caryon GPU server, rented and installed in your datacenter. Nothing to procure.
Your dedicated VPC
Your own private cloud environment, provisioned and operated by Caryon.
No external inference calls with your confidential data. No third-party API in the loop without your approval. No training on your files. End-to-end encryption.
This is architectural, not contractual. There is no configuration in which your confidential files reach an LLM vendor by mistake.
Enterprise-grade security and controls
ISO 27001
The international standard for information security management. Certification in progress.
ISO/IEC 42001
The management system standard for AI, aligned with the EU AI Act. Certification in progress.
GDPR
DPA available, data minimisation by design, documented sub-processors, EU hosting.
21 CFR Part 11
Electronic records and signatures: audit trails, access control, signature integrity.
ISO/TR 80002-2
Software validation approach applied to our own platform and to the CSV use case.
End-to-End Encryption
Data encrypted in transit (TLS 1.3) and at rest (AES-256). Strict access controls.
Book a demo
Helping Every Teams To Maintain Quality & Compliance Across The Full Product Lifecycle
Q&A
The questions QARA teams
ask first.
Inside your perimeter. Either on a Caryon GPU server installed in your datacenter, or in a dedicated VPC we provision and operate for you.
Something else? Ask us directly.