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.

THE AUDIT PACK IS ALREADY BUILT

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.

The Results

950+

Users on one QMS after a merger

Linical

50%

Fewer nonconformances and significant deviations

Wellcome-HRB

30–40 min

To scan the whole QMS for gaps

AGADA Biosciences

How it works

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.

SPONSOR AND REGULATORY AUDITS UNDER GCP

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

Qualio compliance frameworks view showing clause coverage and open gaps for each framework

DEVIATIONS AND CAPA UNDER GCP AND cGMP

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

CAPA-034 for a cleanroom humidity excursion, from deviation DEV-112 through root cause, corrective action and effectiveness check, with its audit trail

TRAINING AND CHANGE CONTROL UNDER PART 11

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