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Inspections Prompt EU Advice On Validating Computerized Clinical Trial Systems

 
• By Vibha Sharma

Deficiencies relating to the qualification and validation of computerized systems used for managing clinical trial data remains an ongoing concern for the European Medicines Agency, which has now issued advice on the matter.

Young businessman working on a virtual screen of the future and sees the inscription: Clinical trial
Sponsor Is Responsible For Validating Clinical Trial Computer Systems • Source: Shutterstock

The European Medicines Agency has expressed concern over recent inspection findings where clinical trial sponsors were unable to demonstrate how they qualified/validated the computerized systems that are used for managing trial data.

The inspection findings have prompted the EMA to issue a notice to trial sponsors on the topic, which clarifies that failure to document and demonstrate the validated state of...

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