EVOLV drafts your requirements, test scripts, and traceability in minutes — then independently verifies every output against the GAMP 5 corpus. Every signature stays human. Every decision is inspectable by an auditor.
URS, FRs, risk assessments, OQ scripts, traceability matrices — written manually, per system, per change, per site.
The day validation closes, the documents start aging. Change requests pile up and nobody knows what's still in a validated state.
Generic AI tools can't survive an inspection. If the auditor can't re-derive the reasoning, the output is a liability, not an asset.
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.
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). We'll show you that path.
Now the interesting question — which assurance tier does it need? Pick the closest description:
EVOLV runs the full GAMP 5 V-model as a living system — from a one-paragraph brief to a signed Validation Summary Report, with a traceability matrix that updates itself as tests run and changes land.
Every AI output is independently verified, hash-chained, and signed by your people. The Logic Archive lets an inspector replay any decision. You stay the signatory — EVOLV just removes the authoring grind.
GAMP 5 Rev 2, 21 CFR Part 11, EU Annex 11, ICH Q9, FDA CSA — cited per requirement and per test step, with version detection when guidance changes underneath you.
The Bounded Autonomy Profile gives every AI deployment a tier, a control catalogue, and hard exclusions. It's the governance framework your AI strategy is missing — validation is where it starts.
Most AI tools ask your QA team to trust a black box. EVOLV is built so nobody has to trust anything — every claim below is verifiable in the product.
Every AI agent carries a machine-readable permission envelope: allowed actions, forbidden actions, data classifications, and which outputs require human sign-off. Malformed passports crash the server rather than serve bad data.
Inspectable via APIA separate verification agent checks every AI draft against the GAMP 5 regulatory corpus — criticality alignment, rationale relevance, contradiction scan. Non-compliant drafts are rejected and logged as compliance exceptions.
Rejections are audit eventsEvery AI decision writes its full reasoning chain — inputs, steps, outputs — hash-linked (SHA-256) to a tamper-evident audit trail. An inspector can re-derive any decision from its inputs alone.
21 CFR Part 11 audit trailPhase completion, change control, release go-live — every irreversible step gates on a named human signature with a Manifestation of Signature page. The AI proposes; it never has the last word.
Enforced in the passport layerReading this list is the fastest way to understand how EVOLV treats risk. These are structural exclusions — no amount of controls rescues them.
21 CFR Part 11 §11.50 binds a signature to a named human. An AI cannot be the named signatory.
Batch release is a Qualified Person responsibility under GMP. It cannot be delegated to an AI in any shape.
CAPA closure requires independent review and effectiveness assessment under 21 CFR §820.100.
That's FDA SaMD territory — a different product with a different regulatory pathway. Not ours.
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.
"With every project you worked on, you went over and above what was asked for, and your attitude was always positive, bright, and inspiring."
— Director, IT CSV · on working with EVOLV's founder
"You were such an integral part of our successes. You made my job easier just knowing I had your support along the way."
— Sr Manager, GxP Global Quality Systems · on working with EVOLV's founder
"I built EVOLV because validation deserves better than choosing between speed and defensibility. Every design decision starts from one question: will this survive an inspector asking 'show me how the AI decided that'? If your QA team wants to try to break it, I'd genuinely love that meeting."
Bring one real requirement from your current validation backlog. We'll draft it, verify it, risk-rank it, and hand you the signed PDF — live.