EVOLV | The Validation Factory
The first AI-native Computer System Validation platform built for GAMP 5, 21 CFR Part 11, and FDA QMSR. Generate compliant URS, automate risk assessment, and govern AI model changes — in minutes, not months.
The Problem
Life sciences teams spend months on documentation that should take days. Regulatory guidance has changed. Most platforms haven't.
Requirements written manually in Word, reviewed in meetings, rewritten after audit findings. No regulatory traceability. No version control. Just documents.
FDA's QMSR replaced the QSR on February 2, 2026. The PCCP final guidance landed August 2025. Most validation plans still cite rules that no longer exist.
Drug interaction predictors and defect classifiers are being deployed with no PCCP, no change control, no audit trail. FDA inspectors are starting to notice.
The Platform
From first requirement to post-market governance — every step compliant, auditable, and powered by AI that knows GAMP 5.
Generate GAMP 5-compliant URS from plain English. SMART refinement, PCCP verification, UR/FR decomposition, CSA test scripts, and PDF export with e-signature — in one guided workflow. What took days takes minutes.
ServiceNow change requests cross-referenced against your system portfolio in real time. GxP classification, GAMP-aware risk calculation using Severity × Occurrence × Detectability, and automatic revalidation flags. No spreadsheet required.
Validated AI models treated as GAMP Category 5 assets. PCCP-aware change assessment aligned to FDA final guidance August 2025. Human-in-the-loop approval queue with 21 CFR Part 11 compliant audit trail.
Every system, every site, every phase — one view. RAG status, action items, regulatory due dates. Register new systems with GxP classification and track their full validation journey from plan to monitor. Built for QA Heads and CTOs.
See It In Action
Three real workflows. No voiceover scripts. No slides. Just the platform doing what it's built to do.
Demo 01
URS generation from plain English → SMART refinement → risk assessment → CSA test script → PDF with e-signature.
Demo 02
ServiceNow CR received → portfolio cross-reference → GAMP risk calculation → revalidation decision. Automatic.
Coming Soon
Recording this weekDemo 03
Architecture change on a validated AI model → PCCP assessment → Governance Hub → HITL approval. 21 CFR Part 11 audit trail.
Generate a real GAMP 5-compliant URS from your own requirement. No login required.
▶ Open Live DemoBuilt For
Whether you're defending a validation package in an inspection or governing 150 systems across 25 sites — EVOLV gives you the records to back it up.
🧪 QA Head · CSV Manager
EVOLV generates, verifies, and manages your entire validation portfolio with a complete audit trail FDA inspectors can review on the spot.
📋 VP Regulatory Affairs
QMSR is mandatory. PCCP guidance is final. EVOLV cites the right regulations, routes the right changes, and produces the records you need when an inspector walks in.
💻 CTO · CDO
EVOLV gives you the governance infrastructure to deploy AI in GxP contexts without regulatory exposure — with a full HITL approval layer and immutable decision records.
Regulatory Coverage
Early Access
We're working with a small group of pharma and biotech companies before general availability. Early access partners get priority onboarding, direct access to the founding team, and founding-tier pricing locked in permanently.