---
title: "QMS Software for CROs and CDMOs | Qualio"
canonical: "https://www.qualio.com/solutions/cro-cdmo"
updatedDate: "2026-11-04T14:49:24.000Z"
description: "Qualio runs the procedures, training, deviations and CAPAs that sponsors audit at CROs and CDMOs, and assesses each record against GCP, ICH E6(R3) and cGMP."
---

# QMS Software for CROs and CDMOs | Qualio

Qualio runs the procedures, training, deviations and CAPAs that sponsors audit at CROs and CDMOs, and assesses each record against GCP, ICH E6(R3) and cGMP.

## Every sponsor audit answered from one system

Procedures, training, deviations and CAPAs for every study, batch and client. Assessed against GCP, ICH E6(R3) and cGMP as they change.

## Each sponsor audits you, and each one asks for the same evidence

A CRO or CDMO is audited by its sponsors as well as by regulators. Under ICH E6(R3) sponsors answer for the work they delegate, so the audits come more often. Quality spends each one pulling the same files from different places.

### Procedures sit on a shared drive

Each sponsor gets a copy, and nobody is sure which version they saw.

### Training sits in spreadsheets

The records for each study team are rebuilt for every audit.

### Deviations sit in a tracker

Each one is chased to its CAPA before the auditor asks.

## Qualio runs the processes sponsors audit and assesses each record against GCP

Qualio holds the procedures, training, deviations, CAPAs and supplier files your sponsors read, each routed to the people who sign it. It maps GCP, ICH E6(R3), Part 11 and cGMP to those records and assesses each one as it changes. When a sponsor books an audit, the evidence is already filed by clause.

Users on one QMS after a merger

Fewer nonconformances and significant deviations

To scan the whole QMS for gaps

## One quality system for every study and every client

Qualio reads SharePoint and Confluence as they are, so the procedures you already have move in without a rewrite.

### Quality Management

Qualio holds the procedures, training, deviations, CAPAs, change controls and supplier files every site works in, so each sponsor reads the approved version.

### Compliance Frameworks

Qualio maps GCP, ICH E6(R3), Part 11 and cGMP once and assesses every record clause by clause as it changes, so you find each gap before the sponsor does.

### Copilot

Drafts the deviation write-up, the change control, the CAPA and the training quiz from your own records. Every output cites its source and waits for your approval.

## Hand the auditor the evidence by clause, the day they ask

- See where every procedure and record stands against GCP and ICH E6(R3) before the auditor arrives
- Export the evidence for each clause, with the approvals and training records behind it
- Close each finding against its clause, with the CAPA linked

## Every protocol deviation is traceable to the CAPA that closed it

- Log the deviation against the study, the procedure and the site it concerns
- Open the investigation from the event, with the write-up drafted and waiting for the investigator's signature
- Pull the trends by study, site and client when a sponsor asks

## A new SOP retrains every study team before it takes effect

- Route each change to the approvers your procedure names and sign it under Part 11
- Make it effective on the date you set, and the retraining goes out that day
- Show a sponsor who was trained on which version, and when

## What CROs and clinical research teams say

## More for CRO and CDMO teams

## Less time on audit prep. More time on the studies.