Clinical trialsOfficial

EMA publishes notice to sponsors on validating computerised systems in clinical trials

🇪🇺 EMA · Wed 28 Oct 2026

The EU regulator has issued a notice on the validation and qualification of computerised systems used in clinical trials; the details are not set out in the information available.

The European Medicines Agency (EMA) has published a notice to sponsors on the validation and qualification of computerised systems used in clinical trials. The item is dated 28 October 2026.

The text of the notice was not available when this article was prepared, and the summary on file gives no detail on its specific requirements, scope or any timelines. This report is therefore limited to the existence and subject of the publication.

As general context, computerised systems used in clinical trials, such as those that capture, process or store trial data, are generally expected to be fit for purpose and to support the reliability of trial data. Validation and qualification are the usual means of demonstrating this.

Sponsors should consult the notice on the EMA website directly to confirm what it asks of them.

What it means for your team

  • Sponsors and their QA teams should read the notice and compare it with their current computerised system validation procedures.
  • Teams responsible for data integrity should check whether existing practices for clinical trial systems are consistent with the notice.
  • Pharmacovigilance teams that rely on trial systems for safety data should check with QA whether the notice affects them.
  • No requirements or deadlines can be confirmed until the full text has been reviewed.

Official source: EMA ↗

Article written by VigiEye from the official source (EMA). AI-assisted; check the source before acting.

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