Prototype
Shape working software
AI-assisted prototyping turns domain context into usable software that can be reviewed, tested, and promoted.
Yttrigen · Validated Velocity
Yttrigen helps regulated healthcare, pharma, and medtech teams turn working software into governed, tested, deployable applications with validation evidence built into the lifecycle.
lifecycle stages under one governed path
of releases carry archived evidence
evidence pillars: traceability, OQ, PQ, and release gates
continuous trail from prototype to production
Governed SDLCOQ and PQ evidenceTraceabilityRelease control21 CFR Part 11 awareCSA/CSV compatible
Assurance pipeline
One governed path from prototype to production, with evidence attached at every stage.
Govern
Promote into control
A Yttrigen Project gives the work a governed lifecycle with change context, traceability, and review points.
Validate
Prove the behavior
ValidKeep connects requirements, OQ drivers, PQ telemetry, signatures, and release evidence.
Deploy
Release with handoff
Yttrigen delivery prepares the validation package, environment path, deployment record, and operating handoff.
Operate
Preserve continuity
The production path keeps evidence, operational context, and support decisions attached to the software.
Traceability
Every important decision has a line back to intent.
OQ Evidence
Business behavior is exercised, not merely described.
PQ Evidence
The running system proves its operating profile.
Release Gates
Promotion is explicit, reviewable, and recorded.
Build in Studio
AI-assisted prototyping with container preview, Git-backed saves, and a path to promotion when you are ready for validation.
Govern with ValidKeep
Governed SDLC, assurance profiles, OQ drivers, PQ telemetry, signatures, and release evidence: connected to your working software.
Environment landscape
High Assurance Landscape
Non GxP
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Skip
Sandbox
Immediate VM preview
Online
Prototype
Free online preview
GxP
Local Development
Developer laptop
CR-101
Development
devcr/* branches
CR-101
CR-102
CR-103
Integration
CR merge & PR
Release R-42
Verification
verifyrelease/*
Live
Production
main branch
Verify in the CLI
validkeep-cli
Built for regulated teams
Quality leaders
Evidence, signatures, and release gates you can defend in audit.
IT and platform
Governed landscape, environment promotion, and operational handoff.
Operations
Software that keeps working with traceability after go-live.
Product owners
Move from prototype to production without rebuilding from scratch.
Internal quality toolsSpreadsheet remediationClinical and quality operationsMedtech softwarePharma manufacturing support
"Validation is not the tax you pay after building. It is the evidence the software carries as it moves."
Blog by topic
Methodology and architecture writing, grouped by theme.
Platform & architecture
ValidKeep ecosystem, governed SDLC landscape, assurance profiles, and ysbuild authoring.
Validation methodology
OQ at capability boundaries, PQ under load, fractal modules, and verification architecture.
Regulated AI
Deterministic build strategies and agent governance in GxP contexts.