This document, first published on 7 April 2020, has been updated to refer to currently applicable Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use and to the revised ICH E6 (R3) Guideline for Good Clinical Practice.
References to Q&As published on the EMA website have been replaced with reference to Guideline on computerised systems and electronic data in clinical trials.
These changes are administrative in nature and do not alter requirements.
📅 Release Date: 29 october 2026
🏛️ Regulatory Body: European Medicines Agency (EMA)
📄 Document: Notice to Sponsors on Validation and Qualification of Computerised Systems Used in Clinical Trials (Rev. 1)
🔗 Read the official notice :https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/notice-sponsors-validation-qualification-computerised-systems-used-clinical-trials_en.pdf