Product

AuditTrak

The single workspace for GxP requirements, tests, and traceability

AuditTrak centralizes your GMP lifecycle documentation — URS, FS/DS, risk assessments, test scripts, and executed results — in one validation-ready workspace.

Generate real-time traceability from requirement to test run, keep your validation pack always audit-ready, and cut the effort to manage changes, re-tests, and impact assessments.

Built for Life Sciences IT / OT Use cases CSV, CSA, Annex 11, Part 11 Teams Quality, Validation, IT
Download sample validation pack
AuditTrak UI showing trace matrix and test runs
See how AuditTrak compresses validation cycles

Watch a real example of mapping URS → risks → tests → executed evidence in minutes, not weeks.

Watch mini-demo
Overview

One place for all validation artifacts

AuditTrak is a lightweight validation workspace that brings together requirements, design, risk, and testing so you don't have to chase Word docs, Excel matrices, and SharePoint folders across your SDLC.

Capture URS and FS/DS, link them to risk items, align test scripts, and attach executed evidence — all with a live traceability matrix that updates itself as you work.

When it's time for an audit or release, generate a clean validation pack with the exact structure your SOPs expect, including electronic sign-off history and execution logs.

Visual concept:

URS → Risk Items → Test Cases → Test Runs → Evidence

Every link visible in one trace matrix and one change history view.
Automation where CSV teams actually need it

AuditTrak doesn't try to be an LIMS or QMS. It focuses on the work validation and quality teams do every day: requirements, tests, and evidence.

Smart traceability builder

Import existing URS / FS spreadsheets and test lists, then auto-create links and coverage views so you can see which requirements are untested, partially tested, or impacted by change.

Release pack generator

Generate a validation summary, trace matrix, test inventory, and execution logs formatted to your templates, so you can drop the output straight into your QMS or document management system.

Why AuditTrak

From scattered files to a controlled validation workspace

Embed AuditTrak overview video here

Single source of truth

Link URS, FS/DS, risk items, tests, and evidence together instead of maintaining three different spreadsheets and a folder jungle.

Faster changes

When a requirement changes, AuditTrak highlights impacted tests and evidence so you can plan re-testing without guesswork.

Audit-ready by design

Every executed test has who/when/what, including attachments, comments, and electronic signature history ready for inspectors.

Fits your SDLC

Use AuditTrak alongside Jira, Azure DevOps, or your existing QMS — not as a replacement for everything you already have working.

Customer profile

Built for lean validation and IT quality teams

Biotech
Cell & Gene
Med Device
CDMO
SaaS Vendors
GxP IT Services
What teams say

Validation work without the spreadsheet maze

“We used to track URS, risks, and tests in three different tools. AuditTrak gave us one live trace matrix and cut the time to prepare for audits dramatically.”

IT System Owner
Global Biologics Manufacturer
View sample trace matrix
Resources

Explore AuditTrak

Want to see AuditTrak on one of your systems?