---
title: How Cogstate cut ISO audit prep in half and is tripling its compliance coverage with Qualio
canonical: "https://www.qualio.com/customers/cogstate-case-study"
updatedDate: "2026-10-26T21:28:43.000Z"
description: "How a neuroscience endpoint company cut ISO 9001 surveillance audit prep by 50%, predicted more than 70% of auditor findings in advance, and is pursuing three more compliance frameworks simultaneously."
categories: [Clinical Trials]
---

## How Cogstate cut ISO audit prep in half and is tripling its compliance coverage with Qualio

faster ISO 9001 surveillance audit prep

of auditor findings predicted before the audit

more compliance frameworks pursued in parallel

Qualio gives us a clear picture of where we stand. It saves time on the initial work so we can focus on more strategic things.

## Results

Cogstate, a neuroscience endpoint company serving global biopharma sponsors, cut ISO 9001 surveillance audit prep by 50%, predicted more than 70% of auditor opportunities for improvement in advance, and is now achieving compliance readiness across three more standards simultaneously, with the same QA team.

[Compliance Intelligence](/compliance-management-software) replaced Cogstate's manual, sequential compliance process with always-on gap visibility, enabling a lean QA team to prep faster, predict more, and achieve compliance readiness with more standards at once.

> Before Qualio, the level of manual effort required to pursue new certifications meant we could only take on one standard per year. Now, we're managing multiple frameworks simultaneously and staying ahead of them.
>
> — Allison Iles, Quality Engineer, Cogstate

## How it works

Cogstate serves clinical trial sponsors who regularly audit their vendors against ISO, FDA, and GxP requirements. Before Qualio, the team tracked every requirement in spreadsheets, mapping hundreds of documents clause by clause to regulatory requirements. A full gap analysis for a single framework could take several weeks.

[Compliance Intelligence](/compliance-management-software) accelerated audit prep for Cogstate's ISO 9001 surveillance by 50%, with AI-supported gap analysis and mapping of SOPs, procedures, and records to clause-level 9001 requirements.

Next, Cogstate is focused on demonstrating compliance with ISO 13485 and preparing for an ISO 27001 surveillance audit with Qualio, while simultaneously using the system to assess and monitor compliance with ICH GCP E6 R3, 21 CFR Part 11, and ISO 9001. This is allowing Cogstate to manage dozens of annual customer audits more effectively, replacing audit prep sprints with continuous visibility of compliance against regulatory requirements.

Qualio's cross-standard document mapping showed that Cogstate is already meeting more than 80% of their ISO 13485 requirements, saving the team months of groundwork. Qualio's remediation recommendations have also extended QA's reach: the IT team managing ISO 27001 can now act on gaps independently, without relying on QA for every question.

As Cogstate manages quality and compliance processes in Qualio, their risk analysis updates in real time.

## Get audit-ready in weeks. Stay audit-ready forever.