EVOLV | The Validation Factory — AI-assisted Computer System Validation

01The credibility engine

Every validation vendor shows you customer logos. We're early — so we show you the evidence instead. It's the harder thing to fake, and the only thing an inspector actually accepts.

Self-validation

We validated EVOLV with EVOLV

A signed 12-page validation package — Plan, IQ, OQ, and a 253-requirement traceability matrix — generated by our own methodology, eval suite executed live.

Live screener

Try to get past our refusals

The five hard exclusion rules run in your browser. Type a use case; watch it pass or get refused, with the regulation cited. No form, no call.

Chained audit trail

Every AI decision, re-derivable

Hash-chained logging plus a Logic Archive per decision. "Show me how the AI decided that" has a literal, replayable answer.

Trusted evals

Proven on every change, in the open

136 deterministic checks gate CI on every push. When they find a hole in our own rules — they have — we publish it.

02The platform

One lifecycle. AI drafts the left arm. Humans sign every gate.

The GAMP 5 V-model, run as a living system — from a one-paragraph brief to a signed Validation Summary Report.

Paste a brief → AI-drafted requirements with regulatory citations → risk-adaptive test scripts → executed runs with defect capture → signed, inspection-ready PDFs.

AI drafts, human signs Human executes, AI assists

app.evolifeval.com / lifecycle

Lifecycle

The V-model, alive

Every phase shows its real state — done, in-flight, or blocked. The living traceability matrix updates itself as tests run and changes land, so "are we still validated?" is a number, not a memory.

app.evolifeval.com / dev-portal / trusted-evals

EVOLV Trusted Evals — 136 of 136 deterministic checks passing

Proof, on demand

Run the eval suite yourself

Every specialist function has a standing test set that gates CI on every push. Run all 136 from the Dev Portal, or bring your own golden set and test us on your requirements — same engine, same report.

03Live · runs in your browser

Screen your AI use case in 30 seconds.

Describe how you want to use AI in your GxP environment. This runs the same five hard-exclusion rules our Bounded Autonomy Profile engine applies — deterministic, no data leaves this page.

Your AI use case

Deterministic rules · nothing is sent to a server

⛔ BAP-X — OUT OF ENVELOPE

This isn't a "needs more controls" verdict — it's a shape problem. No tier of paperwork rescues it. The good news: most excluded use cases have a nearby re-scoped shape that works (AI proposes, human signs).

Email us this result — get the re-scope path

✓ NO STRUCTURAL EXCLUSION

Your use case clears the five hard-exclusion rules.

Now the interesting question — which assurance tier does it need? Pick the closest description:

Get the full signed BAP assessment → Signed PDF · tier-graduated controls · fragility markers

04The honesty contract

Five deployments we refuse. Regardless of revenue.

Reading this list is the fastest way to understand how EVOLV treats risk. These are structural exclusions — no amount of controls rescues them.

EX-1

AI executes an electronic signature

21 CFR Part 11 §11.50 binds a signature to a named human. An AI cannot be the named signatory.

EX-2

AI releases a batch or lot autonomously

Batch release is a Qualified Person responsibility under GMP. It cannot be delegated to an AI in any shape.

EX-3

AI closes a CAPA or deviation on its own

CAPA closure requires independent review and effectiveness assessment under 21 CFR §820.100.

EX-4

AI makes a clinical decision affecting a patient

That's FDA SaMD territory — a different product with a different regulatory pathway. Not ours.

EX-5

AI writes to a validated record without a human gate

Every modification to a controlled record carries an accountable signature — 21 CFR §11.10(e).

A vendor who never says no to your use case isn't assessing it. The exclusion rules run live in the screener above — try to get past them.

05What lands on your desk

Inspection-ready artefacts, signed and versioned.

Validation PlanPhase-1 PDF, signed

URS / UR / FRwith regulatory rationale

Risk AssessmentsGAMP 5 + CSA matrices

Test Scriptsper-step citations

Design Specificationtraceability included

Validation SummaryPhase-6 closing PDF

Traceability MatrixUR → test → defect → release

Audit Trail Exportfiltered, signed, chained

06Who built this

Sreejith Kanhirangadan, founder of EVOLV

Built by a practitioner. Not a holding company.

Most validation software is built by people who left the industry years ago — or by companies where nobody writing the code has ever sat through an inspection. I'm not that.

I still do CSV. I've used ValGenesis, Kneat, Veeva, Polarion — and hit the wall each one leaves you at. I've worked across big pharma, mid-size, and startups, so I've seen the whole landscape, not one corner of it. And I've taught it: 11 courses, 10,000+ CSV professionals across the globe.

I built EVOLV because I wanted the tool I kept wishing existed — fast and defensible, built as if the auditor is the most important person in the room. Not a headless product. If you want to know why it works the way it does, the answer is simple: because I've had to defend this work myself.

Still practicing CSVbig pharma → startup 11 courses10,000+ professionals taught

Sreejith Kanhirangadan

Founder, EVOLV · LinkedIn · sreejith@evolifeval.com

AI drafts your validation.
Then proves every decision it made.