"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."
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.
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
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.
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
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.
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.