"Our audit preparation used to be a three-week project every time: gathering documents, matching versions, closing gaps. Now the audit trail stays continuously current. Our last inspection prep took us four days instead of fifteen."
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What is Entelion
We are building the category between tools and consultants.
Today, life sciences companies face a binary choice: buy a tool and do the validation yourself, or hire consultants who do it for you but cost a fortune and do not scale. Entelion is the third option: the execution capability of a consultant at the price and scale of software. We call it Autonomous Validation Lifecycle Management, and our ambition is to make continuous system assurance the invisible, effortless standard for the industry.
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Automation with human accountability
The AI proposes, the human disposes.
Audit trust
Transparency is engineered into every artifact, not promised in a slogan.
Continuous assurance
Validation is a living state, not a one-time document.
Compliance as an accelerator
The best way to protect patients is to make quality effortless, continuous, and intelligent, so teams get back to the work that matters.
Platform Summary
How we hold ourselves to it
Anyone can publish a list of values. We’ve built ours into the product itself. The checkpoints, the audit trail, the way the system asks before it acts.
Resource
The Entelion Blueprint
Our methodology in one place: how autonomous validation works, the four principles it is built on, and what inspection-defensible means to us. The reference document for anyone evaluating how Entelion actually operates.
01
Human accountability
The AI proposes, the human disposes. Every artifact carries a name and a signature.
02
Audit trust
Transparency engineered into every artifact, not promised in a slogan.
03
Continuous assurance
Validation is a living state, not a document you file away.
04
Single system of record
Every system, every piece of evidence, one traceable place.
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Resource hub
Practical guides and sessions for teams putting continuous validation to work.
Guide
Onboarding your first system: a step-by-step walkthrough
How to scope, document, and validate your first system in Entelion — from intake to signed IQ/OQ.
Guide
Risk assessment template for GAMP Category 5 systems
A ready-to-use framework for classifying risk and defining the depth of testing your auditors expect.
Webinar
From spreadsheet to continuous: a migration playbook
What changed for teams that left paper and Excel behind — and what they wished they had known earlier.
See how continuous validation actually works
Walk through the platform with our team. See how it tracks changes, evaluates risk, and keeps you audit-ready.
A walkthrough, not a pitch.
30 minutes with our team. We show how continuous validation actually works, and answer the questions specific to your role, whether that’s day-to-day validation or audit ownership.
Relevant to your role
Built for regulated teams
30 focused minutes
Whether you run validation day to day or own quality and compliance, we tailor the conversation to what’s relevant for you.
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We reply within one business day to schedule.
Security
Built for the most scrutinized industry on earth
You are handing us access to regulated systems, validation records, and audit trails. That requires more than a checkbox. Here is how we earn that trust — with dedicated expertise, data sovereignty, and controls built for GxP from day one.
Platform
One system for your validation portfolio
Entelion runs in two modes under one roof. For modern web and SaaS systems, the AI agent validates fully autonomously. For legacy or on-premise systems it cannot reach directly, it runs an AI-assisted manual mode that still removes most of the busywork. Every system, every piece of evidence, one platform.
Always Validated
The AI-native validation system that logs into your GxP software, runs the validation, and keeps it audit-ready as the system changes. Validation stops being a project you restart. It becomes a state you maintain.
Metrics
Helping teams stay focused and see measurable results
32
hours reclaimed per month
QA teams currently lose an estimated 70-80% of validation bandwidth to manual documentation.
€85k
saved per system
External validation typically runs $50k-150k per system, with consultant-driven portfolios reaching $250k-300k annually.
6
days, not 6 months
Continuous validation collapses a process that traditionally spans months into a matter of days.
01
Explore
Continuously map every regulated system, so nothing enters the picture unmapped.
02
Detect
Catch every change that affects the validated state, from updates to configuration to access.
03
Evaluate
Assess risk and impact before it becomes an audit finding, with the QA lead in control.
04
Generate
Produce validation evidence that holds up to inspection, not just internal review.
05
Maintain
Stay audit-ready year-round: a state you keep, not a project you restart.
Platform Summary
What CSV teams never stop doing
Trusted by the people whose name is on the audit.
"Entelion turned validation from a recurring project into a continuous state. We finally stay audit-ready without restarting the scramble every quarter."
Alex Rivera
BioNova Labs
"Inspection prep used to consume our QA team for weeks. With Entelion the evidence trail is already there — we walk in ready."
Sam Okonkwo
MediCore Systems
What is Entelion
Validation that does the work, not just the paperwork.
Computer System Validation today means months of manual clicking, hundreds of screenshots, and 200 to 500 pages of documents per system, all to prove a system does what it should. The moment you finish, the next vendor update makes part of it obsolete. Entelion replaces that. Our AI agent explores your system, maps it to requirements, executes the tests, captures the evidence, and generates the full validation package: User Requirements Specification, Risk Assessment, Test Scripts, Traceability Matrix, and Summary Report. The output is the product.
Video loop of the agent
Insights
See your whole compliance posture at a glance
Dashboards for validation status across the portfolio, audit readiness, open risks, and the hours and euros saved. Over time, cross-system intelligence: benchmarking and risk scoring learned from real validation outcomes.
Validation workflow/proces
The full lifecycle, from onboarding to signed package
Assistant
An AI agent that operates the software, not just describes it
If your team validates ten or more systems, most of their time goes to screenshots and cross-referencing, not quality. Entelion covers the whole portfolio, replaces 250k to 300k per year of external consultants with predictable software, and keeps every system continuously audit-ready. Your people move from compliance theater to actual quality work.
Knowledge
Requirements that hold up to an inspector
Entelion structures what it finds into a defensible requirements base: grouped by regulated process (not a flat list of buttons), with intended-use context, an explicit criticality rationale, and provenance tags on every requirement (observed, inferred, regulatory, assumed, or needs-confirmation). Every test and every piece of evidence traces back to a requirement, and every requirement traces to its source.