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.

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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.

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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

Explore Platform

Trusted by the people whose name is on the audit.

1666788345753 (1)
"Entelion is the first tool I've seen that genuinely rethinks CSV instead of just digitizing it. By putting AI at the core they take the process to another level and cut the manual work to the bare minimum, I haven't seen anything else come close."

Yannick Waumans

CellCarta

Joseph Turton
"From a CSV perspective, Entelion takes a genuinely useful and innovative approach to applying AI to validation. It goes beyond simply digitising existing templates, helping users build more structured requirements, risk assessments and traceability while keeping expert review and judgement at the centre. It has real potential to reduce the manual effort involved in validation and improve the consistency of the resulting documentation."

Joseph Turton

External CSV Adviser to Entelion (Turton Consulting)

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.

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