Open Source · Self-Hosted · GxP Compliant
OV

OpenVAL

The open source GxP validation lifecycle platform for pharma, biotech, and medical devices.

One platform. Any validation process. Any discipline. Fully auditable.

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373
Database Tables
30
Validation Disciplines
26
Development Phases
58
Protocol Templates
100%
Audit Compliant
Interface Preview

Dark Teal. Built for validation professionals.

A purpose-built design system. Not another blue enterprise tool.

openval.yoursite.com
OPENVAL ◈ MATC · Madison
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🔔
3
ME
VALIDATION
⊞Dashboard
◈Protocols
▶Executions
◆Test LibraryEE
⟳Traceability
QUALITY
✓CAPA7
↻Change Control
⚠Deviations2
DOCUMENTS
⊟Library
◎Pending4
Protocols
LabWare LIMS 8.0 · IQ / OQ / PQ validation project
Total
12
Passed
7
In Review
3
⚠ Action
2
RefTitleStatusDue
IQ-0042LIMS IQ Protocol v1.0● PASSEDApr 01
OQ-0043LIMS OQ Protocol v1.0◉ REVIEWApr 15
PQ-0044LIMS PQ Protocol v1.0⚠ OVERDUEMar 30
UAT-0045LIMS UAT Protocol v1.0◷ DEVIATIONApr 22
Design System

Teal + Gold. Not another blue enterprise tool.

950#002A25
900#004D45
800
600★#00A090
500
400
G600
G★#E2A837
G400
Pass#86C140 — warm lime green
Fail#E54B2E — warm coral red
Deviation#F97316 — orange
AI / EE#8B5CF6 — purple
Info#3B82F6 — blue
Platform

30 validation disciplines. One platform.

Every type of validation your program needs — in a single, auditable system.

💻
Computer System Validation
Full IQ/OQ/PQ/UAT lifecycle. FDA CSA (Sept 2025) dual-mode. DQ, SAT, FAT, retrospective assessment. Reusable test case library.
21 CFR Part 11
⚙️
Equipment & CQV
Equipment qualification, analytical instrument validation, commissioning & qualification with punch items, paperless handover packages, P&ID walkdowns.
GAMP 5
🧬
Process Validation
Stage 1/2/3 (Design → PPQ → CPV). Cleaning validation with MACO/ADE/LD50. Sterilization (F0, SAL). Cold chain / temperature mapping.
FDA PV Guidance
✅
Quality Management
CAPA, Change Control, Deviations, OOS/OOT, Complaints, Audit Management, Periodic Review, Validation Debt Tracker.
21 CFR 211
📄
Document System
Block-based WYSIWYG editor. 58 pre-built templates. Electronic logbooks. Drawing management. Validation packages with release notes.
EU Annex 11
🤖
AI Assistance
Draft generation, regulatory gap analysis, natural language → test steps, video-to-script, completeness scoring, validation debt prioritization.
Enterprise EE
Design Components

Every component designed for GxP workflows.

Status badge library

● PASSED ✗ FAILED ◷ DEVIATION ◉ IN REVIEW ⚠ OVERDUE ◈ APPROVED 🤖 AI ASSIST ◆ ENTERPRISE

Callout personality

ℹ
21 CFR 11.10(e) requirement
Audit trail must capture server-side timestamps only.
★
Action required
Periodic review overdue by 14 days.
✓
All criteria met
24 steps passed. Ready for QA review.

21 CFR Part 11 signature record

Approval block · IQ-0042 v1.0
ME
Michael Escamilla
APPROVED · QA Manager
2026-04-08
14:23 UTC
✓
TJ
Tracy Johnson
REVIEWED · Val. Engineer
2026-04-08
12:11 UTC
✓
RK
Ravi Kumar
AUTHORED · CSV Specialist
2026-04-08
09:45 UTC
✓
+
Director Sign-off · Awaiting signature
Regulatory

Built for auditors. Not just compliance checkboxes.

Every architectural decision made with a regulator in the room.

✓ Compliant
21 CFR Part 11
SHA-256 hash chain audit trail, server-side timestamps, re-authentication at every signing, record hash linkage.
✓ Compliant
EU Annex 11
Validated system with bundled VP-001–VP-015, configurable headers, distribution controls, version management.
✓ Aligned
FDA CSA Sept 2025
Dual CSV/CSA mode. Intended use per feature. Unscripted testing capture. Critical thinking rationale required.
✓ Aligned
GAMP 5 2nd Ed.
Category-driven validation scope. Risk-based testing matrix. Reusable test case library. OOTB/Configured/Custom.
✓ Enforced
ALCOA+
Attributable · Contemporaneous · Original · Enduring · Available — all enforced by architecture, not policy.
✓ Aligned
ICH Q8/Q9/Q10
QbD framework, design space documentation, quality risk management, product lifecycle management.
Database

373 tables. Complete from day one.

UUID primary keys · UTC timestamps · JSON as TEXT for multi-DB portability · No hard deletes anywhere.

Part 1130Core: auth, audit trail, systems, protocols, documents, workflows, CAPA
Part 331Quality: OOS/OOT, EM, stability, batch, complaints, inspection, SPC
Part 533Validation workflows: projects, plans, sign-offs, lifecycle state machines
Part 737Disciplines: logbooks, drawings, cleaning, cold chain, CQV, sterilization
Part 820Document system: block model, flowcharts, validation packages, AI log
Part 991Complete: workspaces, teams, eBR, regulatory, integrations, dashboards
Part 1011Astellas gap fill: RASC, SMM, SRP, EOL, SRS, vendor releases, EHSA
TOTAL373tables across 10 schema parts

Ready to validate differently?

Free, open source, self-hosted. Built for the people who make medicines safe.

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