GMP Validation Platform — Now in Beta

The modern standard for
validation and qualification.

ValiTrail manages the entire lifecycle for equipment, cleanrooms, and computerised systems. Generate compliant requirements, collaborate with suppliers, and capture electronic signatures in one traceable platform.

Built for Regulatory Compliance

21 CFR Part 11
EU Annex 11
GAMP 5 2nd Ed.
Part 11 Audit Trail

Built for complex validation workflows.

Explore the core features that make ValiTrail the most powerful validation lifecycle management platform.

Overview

JD

Overview

Welcome back to ValiTrail

Import PDF
+ Create URS
Pending Approvals
3
Requires your signature
In Review
12
Documents currently routing
Approved
48
Finalized documents
My Action Items
Approval RequiredURS-2026-001Autoclave Validation Q3
Review & Sign
Approval RequiredIQ-2026-042HVAC System Upgrade IQ
Review & Sign
Recent Documents
OQ-2026-011Approved

Bioreactor OQ Protocol

Updated today
URS-2026-005Draft

Packaging Line Upgrade

Updated 2d ago

Validation shouldn't be a compliance risk.

Managing validation documents through scattered Word files and email chains is dangerous. It's impossible to reliably track version history, enforce GAMP 5 testing standards, or manage supplier deviations without a dedicated system. ValiTrail replaces the chaos with a unified, traceable platform.

ValiTrail AI

Extract legacy documents into structured data.

Stop manually copy-pasting from Word docs and PDFs. ValiTrail AI securely extracts requirements from past projects into fresh, compliant templates locally on your device.

Legacy_Autoclave_URS_2018.pdf

USER REQUIREMENTS SPECIFICATION

3.1.2 Alarms: The system shall log all alarms and events in a secure electronic format.

4.5 Materials: Equipment must be made of 316L SS for all product contact parts.

5.0 Doc: The vendor will provide IQ/OQ protocols and execution reports.

ValiTrail URS Structured Data
REQ-001
Software

System shall maintain a secure electronic audit trail of all alarms.

REQ-002
Hardware

Product contact surfaces must be constructed from 316L Stainless Steel.

REQ-003
Vendor

Vendor to supply pre-approved IQ/OQ protocols and execution.

Everything you need for validation and qualification

From initial URS generation to supplier sign-off and beyond — ValiTrail covers the full validation lifecycle.

Intelligent URS Generation

Stop starting from blank pages. Draft testable, measurable requirements using our library of equipment templates, or extract requirements from your legacy PDFs automatically.

Real-Time Supplier Collaboration

Invite vendors directly into the platform. Negotiate requirements point-by-point, handle deviations securely, and eliminate email attachments entirely.

Automated Traceability

Every requirement is automatically tracked from draft to final approval. Never manually update a Traceability Matrix in a spreadsheet again.

Audit Trails & E-Signatures

Native 21 CFR Part 11 compliance. Every action is logged immutably, and documents are routed for compliant electronic signatures.

Compliance AI Assistant

Run automated checks against GxP guidelines before sending your URS to QA. Catch missing edge cases and vague acceptance criteria instantly.

Centralized Validation Hub

Manage validation and qualification portfolios across multiple sites. Say goodbye to fragmented data and track global validation progress in one view.

From template to approved URS in 3 steps

No more Word documents, email chains, or manual version tracking.

1

Draft

Start with a template or import a previous document. Automatically generate measurable requirements tailored to your equipment type.

2

Negotiate

Share a secure link with your supplier to review requirements point-by-point directly in the platform. No more email attachments.

3

Approve

Route the finalized URS for electronic signatures. Lock the version and automatically generate the Traceability Matrix.

8
GAMP 5 Sections
100+
Requirement Templates
Part 11
Native Compliance
10x
Faster Than Word

Ready to modernize your validation?

Join validation teams who are ditching spreadsheets and Word documents for a purpose-built platform. Get a personalized walkthrough today.

Request a Demo